Search PubMed⌕ Search

SEARCH · Search PubMed

Results for “Inhalation”

Search indexed PubMed citations on genomics, clinical trials, systematic reviews and public health. Explore titles, authors and supplied subject terms, then open the PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 739 records · Page 41Linked to original sources

Airway deposition and airway effects of antiasthma drugs delivered from metered-dose inhalers.

Many different metered-dose inhalation devices are becoming available for the treatment of airway diseases. Each of these inhalers differs in its delivery characteristics. An assessment of the efficacy of drug delivery by these inhalers is essential, in view of their therapeutic use. A review of the literature on the relationship between airway deposition and airway effects of drugs delivered from metered-dose inhalers is presented. Nebulizers or spacers are not discussed. The effect of an inhaler depends on the characteristics of the inhaler and the inhalation manoeuvre performed by the patient. This review focuses on the influence of inhaler characteristics on the airway deposition and airway effects. Data from several studies show that there is a significant relationship between the amount of drug deposited in the airways and the airway effects of the drug. Studies on the relationship between airway deposition and airway effect have been troubled by methodological problems, such as the absence of multiple dose comparisons and the difficulty in obtaining steep dose-response curves. The techniques for measuring airway deposition of inhaled drugs, namely the scintigraphic and the pharmacokinetic method, are discussed and compared. The appropriate use of these techniques can help to define and compare the drug delivery characteristics of different devices, thus enabling inhaled therapy to be optimized.

Administration, Inhalation↗

A review of pregnancy outcomes after exposure to orally inhaled or intranasal budesonide.

BACKGROUND: Inadequately controlled rhinitis is associated with worsening asthma, one of the most common potentially serious causes of pregnancy complications. Recent evidence-based guidelines now stress the importance of inhaled corticosteroids as first-line therapy in controlling asthma during pregnancy, with preference given to budesonide. Both inhaled and intranasal budesonide formulations are rated Pregnancy Category B; all other inhaled and intranasal corticosteroids are rated Pregnancy Category C. OBJECTIVE: To review data from clinical and epidemiological studies investigating the effects of orally inhaled or intranasal budesonide on pregnancy outcomes. METHODS: Clinical and epidemiological studies on the effects of maternal exposure to orally inhaled or intranasal budesonide were identified through searches of the literature indexed on Medline or the Developmental and Reproductive Toxicology (DART) database through January 2005. The search terms used were: 'budesonide' and 'pregnancy'; 'pregnancy complications'; 'teratogens'; 'fetus'; 'embryo'; or 'toxicology'. The search was limited to English-language articles and those evaluating humans. Pertinent abstracts were identified from recent US asthma and allergy meetings. RESULTS: A total of five articles and three abstracts meeting the search criteria were identified. Retrospective epidemiological studies and a randomized, placebo-controlled, multicenter trial found no clinically or statistically significant effects on fetal outcomes among more than 6600 infants whose mothers were exposed to orally inhaled budesonide during pregnancy. Women who reported use of orally inhaled budesonide either during early pregnancy only or throughout pregnancy gave birth to infants of normal gestational age, birth weight, and length, with no increased rate of stillbirths, multiple births, or congenital malformations. In a retrospective case-control analysis, no association was found between inhaled budesonide or intranasal budesonide and the overall rate of infant cardiovascular defects. However, a marginally increased risk of less severe cardiovascular defects (odds ratio = 1.58, 95% confidence interval 1.02 to 2.46) was observed with intranasal budesonide in one analysis, possibly the result of a random association due to multiple testing or an unidentified confounder. CONCLUSION: Maternal exposure to orally inhaled budesonide during pregnancy is not associated with an increased risk of congenital malformations or other adverse fetal outcomes in studies of more than 6600 infants. Data on pregnancy outcomes after maternal exposure to intranasal budesonide are limited, but the totality of evidence, including pharmacological studies showing a much lower systemic exposure after intranasal administration, indicates its safety profile is at least comparable with that of orally inhaled budesonide.

Abnormalities, Drug-Induced↗

Novolizer: how does it fit into inhalation therapy?

Inhalation therapy is the preferred route of administration of anti-asthmatic drugs to the lungs. However, the vast majority of patients cannot use their inhalers correctly, particularly pressurised metered dose inhalers (pMDIs). The actual proportion of patients who do not use their inhalers correctly may even be under-estimated as GPs tend to over-estimate correct inhalation technique. Dry powder inhalers (DPIs) have many advantages over pMDIs. Unlike pMDIs, they are environmentally-friendly, contain no propellant gases and, more importantly, they are breath-activated, so that the patient does not need to coordinate actuation of the inhaler with inspiration. Three key parameters for correct inhaler use should be considered when evaluating existing or future DPI devices and especially when choosing the appropriate device for the patient: (1) usability, (2) particle size distribution of the emitted drug and (3) intrinsic airflow resistance of the device. The Novolizer is a breath-activated, multidose, refillable DPI. It is easy to use correctly, has multiple feedback and control mechanisms which guide the patient through the correct inhalation manoeuvre. In addition, the Novolizer has an intelligent dose counter, which resets only after a correct inhalation and may help to monitor patient compliance. The Novolizer has a comparable or better lung deposition than the Turbuhaler at similar or higher peak inspiratory flow (PIF) rates. A flow trigger valve system ensures a clinically effective fine particle fraction (FPF) and sufficient drug delivery, which is important for a good lung deposition. The FPF produced through the Novolizer is also relatively independent of flow rate and the device shows better reproducibility of metering and delivery performance compared to the Turbuhaler. The low-to-medium airflow resistance means that the Novolizer is easy for patients to use correctly. Even children, patients with severe asthma and patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) have no problems to generate the trigger inspiratory flow rate required to activate the Novolizer. The Novolizer uses an advanced DPI technology and may improve patient compliance.

Administration, Inhalation↗

Inhaled human insulin.

The benefit of subcutaneous insulin therapy in patients with diabetes is frequently limited due to difficulty in convincing patients of the importance of multiple daily insulin injections to cope effectively with meal-associated glycemic changes. Thus, the aim of achieving tight glycemic control, which is critical for reducing the risk of long-term diabetes-related complications, frequently remains elusive. The successful development of an inhalable insulin as a noninvasive alternative promises to change the management of diabetes. The first product to become available to patients is inhaled human insulin, a dry-powder formulation packaged into discrete blisters containing 1 or 3 mg of dry-powder human insulin and administered via a unique pulmonary inhaler device. It has recently been approved in both the United States and the European Union for the control of hyperglycemia in adult patients with type 1 or type 2 diabetes. The pharmacokinetic profile of inhaled human insulin closely mimics the natural pattern of insulin secretion, and resembles that of rapid-acting subcutaneous analogs. Similarly to rapid-acting subcutaneous analogs, inhaled human insulin has a more rapid onset of glucose-lowering activity compared to subcutaneous regular insulin, allowing it to be administered shortly before meals. It has a duration of glucose-lowering activity comparable to subcutaneous regular insulin and longer than rapid-acting insulin analogs. Inhaled human insulin effectively controls postprandial glucose concentrations in patients with type 1 or type 2 diabetes without increasing the risk of hypoglycemia, and even improves fasting glucose levels compared to subcutaneous insulin. Inhaled human insulin has an overall favorable safety profile. There are small reductions in lung function (1-1.5% of total lung forced expiratory volume in the first second [FEV1] capacity) after onset of treatment that are reversible in most patients if treatment is discontinued. Inhaled human insulin is associated with an increase in insulin antibody titers, especially in patients with type 1 diabetes. These increases are not associated with any clinical sequelae. Patient satisfaction data have shown that inhaled human insulin is associated with greater treatment satisfaction relative to subcutaneous insulin in patients with type 1 or type 2 diabetes. This review summarizes the current data on the clinical efficacy and safety of inhaled human insulin in patients with type 1 or type 2 diabetes.

Administration, Inhalation↗

The impact of combined inhaled bronchodilator therapy in the treatment of COPD.

BACKGROUND: Treatment guidelines recommend concomitant use of ipratropium bromide and inhaled beta2-agonists as severity of COPD progresses. While the use of these two agents in a single inhaler may enhance patient compliance and result in cost savings, it may, by itself, increase medication use. We assessed whether the introduction of a combined inhaled bronchodilator in the treatment of COPD modifies the use and costs related to prescribed medications. METHOD: A cohort of subjects > or =45 years old initiating treatment with either a combined inhaled bronchodilator (641 subjects) or ipratropium bromide and inhaled beta2 -agonist (411 subjects) between July 1, 1996, and June 30, 1997, was identified using the Saskatchewan Health databases. The primary outcomes were prescribed medication usage and the subsequent related costs during a 1-year follow-up period. Poisson regression analysis was used to estimate rate ratios (RRs) adjusted for drug use and hospitalization during the year prior to cohort entry. RESULTS: The adjusted RR of inhaled bronchodilator use was elevated for combined inhaled bronchodilator therapy (adjusted RR, 1.16; 95% confidence interval [CI], 1.07 to 1.26). However, the overall costs associated with these inhaled bronchodilators were reduced with combined inhaled bronchodilator therapy (adjusted mean ratio, 0.83; 95% CI, 0.76 to 0.92). The rate of use of other respiratory drugs and antibiotics was similar (adjusted RR, 1.03; 95% CI, 0.93 to 1.16). Applying the rate ratio for cost savings to all new, combined inhaled bronchodilator users led to estimated annual savings in Canadian dollars of 103,468 dollars (95% CI, 48,694 dollars to 146,082 dollars) in this province. CONCLUSION: The introduction of a simpler bronchodilator dosing regimen did not significantly alter the treatment of COPD and resulted in appreciable cost savings.

Administration, Inhalation↗

Underuse of inhaled steroid therapy in elderly patients with asthma.

STUDY OBJECTIVES: Despite their proven efficacy, inhaled steroids may be underused in the elderly asthmatic population. The objectives of this study were to determine if inhaled steroids are underused in the elderly asthmatic population, who are at a high risk for rehospitalization and mortality, and to identify certain risk factors that predict lower use of inhaled steroids in this group of patients. DESIGN: Population-based, retrospective, cohort study using linked data from hospital discharge and outpatient drug databases. PARTICIPANTS: All people > or = 65 years old in Ontario, Canada, who survived an acute exacerbation of asthma between April 1992 and March 1997. MEASUREMENTS AND RESULTS: Of the 6,254 patients, 2,495 patients (40%) did not receive inhaled steroid therapy within 90 days of discharge from their initial hospitalization for asthma. Patients > 80 years old were at a greater risk of not receiving inhaled steroid therapy, compared to those 65 to 70 years of age (adjusted odds ratio [OR], 1.23; 95% confidence interval [CI], 1.05 to 1.47). Patients with a Charlson comorbidity index of > or = 3 were also at an increased risk of not receiving inhaled steroid therapy, compared to those having no comorbidities (adjusted OR, 3.45; 95% CI, 1.56 to 7.69). Moreover, receipt of care from a primary-care physician was independently associated with an elevated risk of not receiving inhaled steroid therapy, compared to receipt of care from respirologists/allergists (adjusted OR, 1.35; 95% CI, 1.10 to 1.61). INTERPRETATION: Forty percent of Ontario patients > or = 65 years old who experienced a recent acute exacerbation of asthma did not receive inhaled steroid therapy near discharge from their initial hospitalization for asthma. Nonreceipt of inhaled steroid therapy was particularly prominent in the older patients with multiple comorbidities. Moreover, those who received care from primary-care physicians were also less likely to receive inhaled steroid therapy, compared to those who received care from specialists.

Acute Disease↗

Factors influencing the responsiveness to inhaled glucocorticoids of patients with moderate-to-severe asthma.

STUDY OBJECTIVES: Inhaled glucocorticoids (GCs) are the most effective control therapy for asthma. Although the clinical effects of inhaled GCs vary, there are few data on the differences in the responsiveness of individuals to inhaled GCs. The purpose of this study was to identify those factors that are associated with responsiveness to high-dose inhaled GCs in patients with moderate-to-severe asthma. DESIGN: This study was a prospective analysis. SETTING: Outpatient clinics of tertiary hospitals. PATIENTS: Eighty-six adult outpatients with moderate-to-severe asthma. METHODS: Eighty-six patients with asthma who had initial FEV1 values of < 80% predicted after they had received inhaled GCs (fluticasone propionate, 1,000 microg/d) for 4 weeks. The primary end points were FEV1, FEV1/FVC ratio, forced expiratory flow (midexpiratory phase), and the score at presentation in the asthma-related quality-of-life questionnaire (AQLQ). RESULTS: The inhalation of GCs for 4 weeks had significant improvements in the FEV1% predicted and in the AQLQ score compared with the baseline values. Asthmatic patients with responses of > 12% (n = 46, 53.4%) in the change in FEV1 (deltaFEV1 = [FEV1 at 4 weeks--baseline FEV1]/baseline FEV1 x 100) also had significantly higher proportions of blood eosinophils and lower FEV1 values (in liters) prior to treatment. The change in FEV1 values correlated with the number of sputum eosinophils prior to GC inhalation (r = 0.242; p < 0.05) and correlated inversely with the FEV1 percent predicted values prior to GC inhalation (r = -0.462; p < 0.001). CONCLUSION: The FEV1 percent predicted and the blood and sputum eosinophil levels prior to GC inhalation are associated with the responsiveness to inhaled GCs in patients with moderate-to-severe asthma.

Administration, Inhalation↗

Inhaled corticosteroids and mortality in COPD.

STUDY OBJECTIVES: To assess the influence of inhaled corticosteroids (ICSs) on mortality in COPD patients, which is currently a controversial topic. SETTING: Manitoba Health maintains a population-wide research database that includes pharmaceutical information. DESIGN AND PATIENTS: We examined mortality in people 90 to 365 days after hospital discharge for COPD, comparing those persons who received inhaled steroids within 90 days of hospital discharge with those who did not. Cox proportional hazards models were used with adjustments for other respiratory drugs, comorbidities, and physician visits before and after hospital discharge. We also compared mortality in patients who received inhaled steroids with those who received other respiratory drugs, but not inhaled steroids, and those who received neither. Using nested case control analysis, we examined the time of receipt of inhaled steroids in relation to fatal events. RESULTS: In people > 65 years of age, inhaled steroids were associated with a 25% reduction in mortality between 90 and 365 days after hospital discharge, while mortality increased with bronchodilator use, physician visits, age, and comorbidities. The exclusion of people who had also received a diagnosis of asthma or had received inhaled steroids before hospitalization did not change the result. Inhaled steroids were associated with an even larger mortality reduction in people aged 35 to 64 years. People who received bronchodilators but no steroids had higher mortality than people who received no bronchodilators or received both bronchodilators and inhaled steroids. The reduction in all-cause mortality was largely due to the decreased number of cardiovascular deaths. The receipt of inhaled steroids within 30 days of death was protective, but this was not the case for greater time intervals. CONCLUSIONS: Therapy with ICSs reduced mortality in COPD patients; the effect was particularly notable for cardiovascular death and was short term in that it was dependent on recent exposure.

Administration, Inhalation↗

Inhaled anesthetic agents.

PURPOSE: The pharmacology, bioavailability and pharmacokinetics, indications, clinical efficacy, adverse effects and toxicities, and dosage and administration of the inhaled anesthetics are reviewed. SUMMARY: The inhaled anesthetics include desflurane, enflurane, halothane, isoflurane, and sevoflurane and are thought to enhance inhibitory postsynaptic channel activity and inhibit excitatory synaptic activity. The mechanism of action of inhaled anesthetics has not been completely defined. A number of factors can influence the pharmacokinetics of inhaled anesthetics, including solubility in blood, cardiac output, tissue equilibration, extent of tissue perfusion, metabolism, and age. All of the available inhaled anesthetics are effective for inducing or maintaining anesthesia or both. Most clinical trials of inhaled anesthetics have evaluated differences in induction and emergence from anesthesia by comparing (1) times to loss of reflex, extubation, and response to verbal commands; orientation to time and place; and ability to sit up without assistance, (2) need for post-surgical analgesia, and (3) time to discharge as measures of efficacy. Adverse effects and toxicities of the inhaled anesthetics include nephrotoxicity, hepatotoxicity, cardiac arrhythmias, neurotoxicity, postoperative nausea and vomiting, respiratory depression and irritation, malignant hyperthermia, and postanesthesia agitation. Safety issues surrounding these gases include occupational exposure and intraoperative fires within the delivery systems used with inhaled anesthetics. Drugs used for anesthesia during surgery can account for 5-13% of a hospital's drug budget. CONCLUSION: The inhaled anesthetics have been shown to be both safe and effective in inducing and maintaining anesthesia. These agents differ in potency, adverse-effect profile, and cost. Newer anesthetic gases, such as sevoflurane and desflurane, appear to have more favorable physico-chemical properties. These factors, as well as patient characteristics and duration and type of procedure, must be considered when selecting an inhaled anesthetic.

Anesthetics, Inhalation↗

The nicotine inhaler: clinical pharmacokinetics and comparison with other nicotine treatments.

Nicotine inhaled in smoke is the most rapid form of delivery of the drug. With smoking, arterial boli and high venous blood nicotine concentrations are produced within seconds and minutes, respectively. The potency of nicotine as the primary reinforcement in tobacco addiction is attributed to this rapid rate of delivery. By design, nicotine treatments reduce the rate and extent of drug delivery for weaning from nicotine during smoking cessation. Theoretically, they prevent relapse by reducing withdrawal and craving associated with the abrupt cessation of cigarettes. The nicotine inhaler treats the complexity of smoking through weaning both from the drug and from the sensory/ritual components associated with smoking. The inhaler is 'puffed' but not lit and there is considerable 'puffing' required to achieve slower rising and lower nicotine concentrations. These factors allow it to be used as a nicotine reduction treatment. One inhaler contains 10 mg of nicotine (and 1 mg of menthol) of which 4 mg of nicotine can be extracted and 2mg are systemically available. Shallow or deep 'puffing' results in similar nicotine absorption. Nicotine is delivered mainly to the oral cavity, throat and upper respiratory tract with a minor fraction reaching the lungs. This was confirmed with positron emission tomography and by assessment of arterial concentrations. A single inhaler can be used for one 20-minute period of continuous puffing or periodic use of up to 400 puffs per inhaler. With controlled puffing in laboratory testing, venous plasma nicotine concentrations from a single inhaler puffed 80 times over 20 minutes averaged 8.1 microg/L at 30 minutes. Lower concentrations of 6.4 to 6.9 microg/L have been reported for self-administration under clinical conditions. The time to peak plasma concentrations varies but is always significantly longer than with cigarette delivery. Estimates of nicotine intake from cotinine concentrations were higher than expected (60 to 70% of baseline smoking concentrations). This elevation may be due to the swallowing of nicotine and subsequent first-pass biotransformation to cotinine. In general, venous blood nicotine concentrations are considerably lower than with smoking and are within the range observed for other nicotine reduction therapies. Efficacy trials show consistent superiority of the inhaler over placebo. Despite the 'cigarette-like' appearance of the inhaler and the associated sensory/ritual elements, little treatment dependence or abuse has been reported. This is attributed to the slow rise time and low nicotine blood concentrations. The inhaler is a valuable addition to treatment of tobacco dependence and can be used alone or with other treatments.

Absorption↗

Pulmonary microvascular responses to inhaled prostacyclin, nitric oxide, and their combination in anesthetized cats.

Using an X-ray television system on anesthetized cats, we directly measured internal diameter (ID) changes in identical small pulmonary vessels (100-1,100 microm ID) in response to inhalations of 25, 250, and 2,500 ng/kg/min aerosolized prostacyclin (PGI2), 4 and 34 ppm nitric oxide (NO), and the combination of aerosolized PGI2 and NO. We also compared ID changes during 250 ng/kg/min PGI2 inhalation both with and without an Nomega-nitro-L-arginine methyl ester (L-NAME, 30 mg/kg I.V.) pretreatment. In the arteries, inhaled PGI2 increased 100-900 microm vessel ID in a dose-dependent manner but caused no significant, or only slight, ID increases in the vessels larger than this. The greatest ID increase ( approximately 22%) was in the 100-500 microm arteries in response to 2,500 ng/kg/min PGI2 inhalation. PGI2 also increased the ID of the veins (6-12%), but the results were not dose related. NO inhalation also resulted in non-uniform ID response patterns similar to PGI2 with no significant, or only minimal, ID increases of the arteries >900 microm. The simultaneous inhalation of 2,500 ng/kg/min PGI2 and 34 ppm NO increased the arterial ID (maximum approximately 34%) more than either drug alone and to almost the same extent as brought about by injected papaverine (2 mg/kg), a smooth muscle relaxant. Inhaled PGI2 (250 ng/kg/min) decreased pulmonary arterial pressure and increased arterial ID to nearly the same extent with or without L-NAME pretreatment. These results indicate that inhaled PGI2 and inhaled NO locally dilate 100-900 microm pulmonary arteries in a dose-dependent manner and with a similar ID response pattern, and that the combination of these drugs produces a more enhanced vasodilator effect compared to their separate effects and induces the maximum dilated states. The data also suggest that inhaled PGI2 dilates these arteries directly, rather than via secondary release of endogenous NO.

Administration, Inhalation↗

Inhaled glucocorticoid therapy in infants at risk for neonatal chronic lung disease.

The primary impetus for the study of inhaled glucocorticoid therapy in the treatment and prevention of neonatal chronic lung disease (CLD) was to achieve effective anti-inflammatory therapy with few adverse effects. Initial reports of inhaled glucocorticoid therapy in infants with established CLD suggest modest improvement in neonatal respiratory outcomes. Recent randomized trials also indicate that inhaled glucocorticoid therapy may provide some benefit, but have not demonstrated a reduction in CLD. Some studies suggest that the pulmonary response to systemic glucocorticoid may be greater and faster than response to inhaled glucocorticoid therapy. Few adverse effects have been noted with inhaled glucocorticoid therapy. One limitation of studies of inhaled glucocorticoid therapy is the uncertainty of the dose delivered and deposited in peripheral airways and regions of the lungs. Experience with and systematic study of inhaled glucocorticoid therapy is still in its early stages. The role of inhaled glucocorticoid therapy in the treatment and prevention of CLD is evolving. Advances in delivery devices and new developments of drug formulations should improve aerosol delivery and deposition in infants. Given the clinical dilemma of systemic glucocorticoid therapy and potential benefits demonstrated by recent trials of inhaled glucocorticoid therapy, further study of inhaled glucocorticoid therapy for CLD is warranted.

Administration, Inhalation↗

Toxicologic testing of inhaled pharmaceutical aerosols.

This paper reviews technical issues related to the toxicologic testing of inhaled pharmaceuticals. Although there are commonalities between approaches to general and inhalation toxicity testing, there also are specific challenges in the toxicity testing of inhaled pharmaceuticals. A major issue is that of dose; inhaled dose is more difficult to determine than intravenous or oral doses. Also, it is harder to relate dose in laboratory animals to that in man for inhalation exposure than for other routes of administration. Additionally, in the case of inhaled pharmaceuticals, people generally inhale through the mouth, whereas most laboratory animals inhale primarily through the nose. This presents significant challenges in exposure methodology and technology that often need innovative approaches involving alteration to particle size of the agent or dosing procedure. Because the respiratory tract is the site of deposition, local respiratory toxicity and possible damage to lung cells need to be assessed. Systemic toxicity also needs to be evaluated and may be an issue in some cases. Special studies on pulmonary function, mucociliary clearance, or immune response may be needed, depending on the nature of the inhaled pharmaceutical. This review explores the main issues involved in toxicity testing of inhaled pharmaceuticals, the approaches that have been used, and the current and future challenges.

Administration, Inhalation↗

[Inadequate technique in the use of inhalers in patients seen at a pneumology clinic].

OBJECTIVE: To assess inhalation technique in out-patient attending a respiratory ward who were using inhaler devices, and to identify factors associated with misuse of these therapies. METHOD: One hundred and seven patients were prospectively studied, of whom 100 completed the study; Inhalation technique was evaluated using a previously elaborated check list. We searched for significant differences between individuals with good or bad inhalation technique. RESULTS: Mean age: 68 +/- 11 years. 68 males and 32 females. Only 31% of cases were observed to make no inhalation errors when first evaluated. Individuals using metered-dose inhalers without spacer chamber made significantly more mistakes than patients using other devices. The main factor associated with poor inhalation technique was found to be the absence of adequate supervised instruction when the treatment was first prescribed. General practitioners were less likely to offer this instruction than other specialists. We did not find significant associations between inhaler misuse and patients' age, sex or the setting (hospital or ambulatory ward) where the treatment was first prescribed. CONCLUSIONS: Incorrect use of inhalers is a frequent finding, and an adequate instruction seems to associate with improvement of patients' skills with use of these devices. Health personnel should be aware that inhalation technique instruction is essential ingredient of patients' management.

Administration, Inhalation↗

Syringe, pen, inhaler - the evolution of insulin therapy.

The therapy with inhalable insulin can be expected to change the present concepts and the market of subcutaneous insulin dramatically within the next years. Several companies are currently developing formulations of inhalable insulin. In the most advanced concept, insulin is delivered as a dry-powder insulin formulation via a special aerosol device system. The phase III studies evaluating the efficiency of the inhaled insulin are already on their way. The recent phase II studies have shown, that the lung is capable of absorbing new insulin formulation in a dose-dependent and reproducible manner. However, a relatively small number of diabetic patients have been included in these studies, yet. The therapeutic efficacy and safety of the inhaled insulin is comparable to that of the usual subcutaneous insulin treatment regimens. The most important advantage of the new therapy is the enhanced therapeutic comfort of the patient who does not need to inject insulin for meal time glucose control. Generally, in terms of glycemic control, inhalable insulin offers no advantages in type 1 diabetics in comparison to an intensified conventional insulin therapy. However, before a large-scale marketing, several open questions have to be carefully investigated, the most important being the possible long-term effects of insulin inhalation for the lung, since insulin is known to have growth-promoting properties. There is still no available clinical data concerning the efficiency of the inhaled insulin in patients with pulmonary diseases which may cause problems in absorption of inhaled insulin due to the smaller cumulative alveolar surface. In smokers without pulmonary disease seems the inhaled insulin to act stronger and faster. Since therapy with inhalable insulin requires larger doses of insulin in comparison to subcutaneous insulin to achieve the same systemic effect, the costs of this therapy need to be clarified, too.

Administration, Inhalation↗

NTP toxicology and carcinogensis studies of vanadium pentoxide (CAS No. 1314-62-1) in F344/N rats and B6C3F1 mice (inhalation).

Vanadium pentoxide, commercially the most important compound of vanadium, presents a potential occupational hazard during the cleaning of oil-fired boilers and furnaces, the handling of catalysts, and during the refining, processing, or burning of vanadium-rich mineral ores or fossil fuels. Vanadium pentoxide was nominated for study by the National Cancer Institute as a representative of the metals class study. Male and female F344/N rats and B6C3F1 mice were exposed to vanadium pentoxide (99% pure) by inhalation for 16 days, 14 weeks, or 2 years. Genetic toxicology studies were conducted in Salmonella typhimurium and mouse peripheral blood. 16-DAY STUDY IN RATS: Groups of five male and five female rats were exposed to particulate aerosols of vanadium pentoxide at concentrations of 0, 2, 4, 8, 16, or 32 mg/m(3) by inhalation, 6 hours per day, 5 days per week for 16 days. Three males in the 32 mg/m(3) group died before the end of the study. Mean body weights of males and females exposed to 8 mg/m(3) or greater were less than those of the chamber controls. Clinical findings included rapid respiration and hypoactivity in rats exposed to 16 or 32 mg/m(3). Relative lung weights of 4 mg/m(3) or greater males and 2 mg/m(3) or greater females were significantly greater than those of the chamber controls. Lavage fluid analysis indicated an inflammatory response in the lung that was either directly mediated by vanadium pentoxide or was secondary to lung damage induced by vanadium pentoxide exposure. 16-DAY STUDY IN MICE: Groups of five male and five female mice were exposed to particulate aerosols of vanadium pentoxide at concentrations of 0, 2, 4, 8, 16, or 32 mg/m(3) by inhalation, 6 hours per day, 5 days per week for 16 days. All males exposed to 32 mg/m(3) and one 8 mg/m(3) male died or were killed moribund before the end of the study. Mean body weights of 16 mg/m(3) males and 8 mg/m(3) or greater females were significantly less than those of the chamber controls, and the 32 mg/m(3) females lost weight during the study. Absolute and relative lung weights of 4 mg/m(3) or greater males and all exposed groups of females and liver weights of 16 mg/m(3) males were significantly greater than those of the chamber controls. The mediastinal lymph nodes were enlarged in 4, 8, and 16 mg/m(3) males and females, and lymphoid hyperplasia was confirmed histologically. Lavage fluid analysis indicated an inflammatory response in the lung that was either directly mediated by vanadium pentoxide or was secondary to lung damage induced by vanadium pentoxide exposure. 3-MONTH STUDY IN RATS: Groups of 10 male and 10 female rats were exposed to particulate aerosols of vanadium pentoxide at concentrations of 0, 1, 2, 4, 8, or 16 mg/m(3) by inhalation, 6 hours per day, 5 days per week for 3 months. Seven males and three females exposed to 16 mg/m(3) died during the study. Mean body weights were significantly less in males exposed to 4 mg/m(3) or greater and in females exposed to 16 mg/m(3). Abnormal breathing, thinness, lethargy, abnormal posture, and ruffled fur were observed in rats exposed to 16 mg/m(3). Hematology results indicated that exposure of rats to vanadium pentoxide induced a microcytic erythrocytosis in males and females. Absolute and relative lung weights were significantly greater for 4 mg/m(3) or greater males and females than for the chamber controls as were the relative lung weights of 2 mg/m(3) males. The estrous cycle of females exposed to 8 mg/m(3) was significantly longer than that of the chamber control group, and the number of cycling females in the 16 mg/m(3) group was reduced. The incidences of several nonneoplastic lesions of the lung and nose were significantly increased in males and females exposed to 2 mg/m(3) or greater. Data from pulmonary function analyses indicated that a restrictive lung disease was present in male and female rats exposed to 4 mg/m(3) or greater, while an obstructive lung disease was present only in the 16 mg/m(3) groups. 3-MONTH STUDY IN MICE: Groups of 10 male and 10 female mice were exposed to particulate aerosols of vanadium pentoxide at concentrations of 0, 1, 2, 4, 8, or 16 mg/m(3) by inhalation, 6 hours per day, 5 days per week for 3 months. One male exposed to 16 mg/m(3) died before the end of the study. Mean body weights of 8 and 16 mg/m(3) males and 4 mg/m(3) or greater females were significantly less than those of the chamber controls. Absolute and relative lung weights of males and females exposed to 4 mg/m(3) or greater were significantly greater than those of the chamber controls. The epididymal spermatozoal motility of males exposed to 8 or 16 mg/m(3) was significantly decreased. Some mice exposed to 2 or 4 mg/m(3) had inflammation of the lung, and all mice exposed to 8 or 16 mg/m(3) had inflammation and epithelial hyperplasia of the lung. 16-DAY SPECIAL STUDY IN RATS: Groups of 60 female rats were exposed to particulate aerosols of vanadium pentoxide at concentrations of 0, 1, or 2 mg/m(3) and groups of 40 female rats were exposed to 4 mg/m(3) by inhalation, 6 hours per day, 5 days per week for 16 days. Alveolar and bronchiolar epithelial hyperplasia was observed in most rats exposed to 2 or 4 mg/m(3) on days 6 and 13. Histiocytic infiltration and inflammation occurred in a time- and concentration-related manner. Cell turnover rates were increased in the terminal bronchioles on days 6 and 13 and in the alveoli in the 4 mg/m(3) group on day 6 and in all exposed groups on day 13. Assessment of lung vanadium concentrations suggested deposition and clearance exhibited linear kinetics over the exposure range studied. Lung clearance half-times ranged from 4.42 to 4.96 days. 16-DAY SPECIAL STUDY IN MICE: Groups of 60 female mice were exposed to particulate aerosols of vanadium pentoxide at concentrations of 0, 2, or 4 mg/m(3) and groups of 40 female mice were exposed to 8 mg/m(3) by inhalation, 6 hours per day, 5 days per week for 16 days. Alveolar and bronchiolar epithelial hyperplasia occurred with similar incidences and severities among the exposed groups on days 6 and 13, and time- and concentration-related increases in the incidences of interstitial inflammation and histiocytic infiltration also occurred in these groups. Cell turnover rates were increased in the terminal bronchioles on day 6 and remained greater than those of the chamber controls on day 13. In the alveoli, cell turnover rates were increased in an exposure concentration-related manner on day 13; cell turnover rates were increased only in the 8 mg/m(3) group on day 6. Assessment of lung vanadium concentrations suggested deposition and clearance exhibited linear kinetics over the exposure range studied. Lung clearance half-times ranged from 2.40 to 2.55 days. 2-YEAR STUDY IN RATS: Groups of 50 male and 50 female rats were exposed to particulate aerosols of vanadium pentoxide at concentrations of 0, 0.5, 1, or 2 mg/m(3) by inhalation, 6 hours per day, 5 days per week for 104 weeks. Survival and body weights of males and females were generally similar to those of the chamber controls. Mean body weights of females exposed to 2 mg/m(3) were less than those of the chamber controls throughout the study. Alveolar/bronchiolar neoplasms were present in exposed groups of male rats, and the incidences often exceeded the historical control ranges. Alveolar/bronchiolar adenomas were present in 0.5 and 1 mg/m(3) females; one 2 mg/m(3) female also had an alveolar/bronchiolar carcinoma. The incidence of alveolar/bronchiolar adenoma in the 0.5 mg/m(3) group was at the upper end of the historical control ranges. Nonneoplastic lesions related to vanadium pentoxide exposure occurred in the respiratory system (lung, larynx, and nose) of male and female rats, and the severities of these lesions generally increased with increasing exposure concentration. 2-YEAR STUDY IN MICE: Groups of 50 male and 50 female mice were exposed to particulate aerosols of vanadium pentoxide at concentrations of 0, 1, 2, or 4 mg/m(3) by inhalation, 6 hours per day, 5 days per week for 104 weeks. Survival of 4 mg/m(3) males was significantly less than that of the chamber controls. Mean body weights of 4 mg/m(3) males and all exposed groups of females were generally less than those of the chamber controls throughout the study, and those of males exposed to 2 mg/m(3) were less from week 85 to the end of the study. Many mice exposed to vanadium pentoxide were thin, and abnormal breathing was observed in some mice, particularly those exposed to 2 or 4 mg/m(3). The incidences of alveolar/bronchiolar neoplasms were significantly increased in all groups of exposed males and females. Nonneoplastic lesions related to vanadium pentoxide exposure occurred in the respiratory system (lung, larynx, and nose) of male and female mice, and the severities of these lesions generally increased with increasing exposure concentration. Bronchial lymph node hyperplasia was present in many exposed females. MOLECULAR ONCOLOGY STUDIES: K-ras codon 12 mutation and loss of heterozygosity on chromosome 6 were detected in vanadium pentoxide-induced alveolar/bronchiolar carcinomas from mice. GENETIC TOXICOLOGY: Vanadium pentoxide was not mutagenic in Salmonella typhimurium strain TA97, TA98, TA100, TA102, or TA1535, with or without induced rat or hamster liver S9 enzymes. CONCLUSIONS: Under the conditions of this 2-year inhalation study, there was some evidence of carcinogenic activity of vanadium pentoxide in male F344/N rats and equivocal evidence of carcinogenic activity of vanadium pentoxide in female F344/Nrats based on the occurrence of alveolar/bronchiolar neoplasms. There was clear evidence of carcinogenic activity of vanadium pentoxide in male and female B6C3F1 mice based on increased incidences of alveolar/bronchiolar neoplasms. (ABSTRACT TRUNCATED)

Animals↗

Recognition and prevention of inhalant abuse.

Inhalant abuse is a prevalent and often overlooked form of substance abuse in adolescents. Survey results consistently show that nearly 20 percent of children in middle school and high school have experimented with inhaled substances. The method of delivery is inhalation of a solvent from its container, a soaked rag, or a bag. Solvents include almost any household cleaning agent or propellant, paint thinner, glue, and lighter fluid. Inhalant abuse typically can cause a euphoric feeling and can become addictive. Acute effects include sudden sniffing death syndrome, asphyxia, and serious injuries (e.g., falls, burns, frostbite). Chronic inhalant abuse can damage cardiac, renal, hepatic, and neurologic systems. Inhalant abuse during pregnancy can cause fetal abnormalities. Diagnosis of inhalant abuse is difficult and relies almost entirely on a thorough history and a high index of suspicion. No specific laboratory tests confirm solvent inhalation. Treatment is generally supportive, because there are no reversal agents for inhalant intoxication. Education of young persons and their parents is essential to decrease experimentation with inhalants.

Administration, Inhalation↗

[Acute effect of inhaled beta(2)-agonists with different type of intrinsic activity on airway resistance in healthy volunteers].

Inhaled beta(2)-agonists (long-acting as well as short acting) are used world-wide for the relief of asthma symptoms. However, there are few reports which have evaluated the additive effect of short-acting beta(2)-agonists to long-acting beta(2)-agonists on airway resistance measured by a plethysmography. This study was designed to evaluate the additive effect of inhaled short-acting beta(2)-agonists (protecarol) to long-acting beta(2)-agonists (salmeterol) on airway resistance in normal healthy volunteers (S+P group). In addition, to compare the effects of beta(2)-agonists which have different types of intrinsic activities, acute effect of inhaled procaterol adding to procaterol was also evaluated (P+P group). Seven healthy volunteers (all male and all non-smokers) were entered in this study. Pulmonary function was measured by a body plethysmography. Forced expiratory volume per 1 second (FEV1), the maximum flow rate at 25% (V(.) 25), the maximum flow rate at 50% of forced vital capacity (V(.) 50), and airway resistance were measured before and after inhalation of salmeterol (1 dry powder, 50 microg) or procaterol (2 puffs, 20 microg). Sixty minutes after inhalation of salmeterol, or 15 minutes after inhalation of procaterol, inhalation of procaterol (2 puffs, 20 microg) was added, and then pulmonary function was monitored. FEV1, V(.) 25, and V(.) 50 were significantly increased after inhalation of salmeterol as well as procaterol. In addition, airway resistance decreased significantly after inhalation of salmeterol as well as procaterol. In the S+P group, additional decrease of airway resistance after inhalation of procaterol was relatively small compared with the P+P group. In conclusion, although additional bronchodilatoric effects were observed in the S+P and P+P group, the effects seemed to be different based on the intrinsic activity of each beta(2)-agonist.

Administration, Inhalation↗