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PubMed2000

Trends in inhalant use among high school students in Illinois: 1993-1995.

Data were analyzed from two years (1993 and 1995) of a statewide survey of high school students on drug use. Changes in the rates of inhalant use, and associations between inhalant use and sociodemographic variables, were examined across the two survey years. Measures of inhalant use included lifetime use, past year use, and past month use. Analyses showed no significant difference in the rates of inhalant use across years. Associations with sex, ethnicity, and age were partly consistent with previous research findings. Both lifetime and recent inhalant use were more prevalent among males than females. Blacks were less likely to use inhalants (lifetime and recent) than other racial/ethnic groups in both survey years. Native Americans showed elevated rates of recent inhalant use in 1993, but not in 1995. While age trends in the 1993 survey were consistent with expectations, age trends in the 1995 survey were not. Recent inhalant use was constant across age groups in the 1995 sample. Also contrary to expectations, inhalant use was not more prevalent in low-income or high-poverty areas. The associations of inhalant use with family intactness and academic performance varied by race/ethnicity. Family intactness was a significant protective factor only for whites and Hispanics. Poor grades were not a significant predictor of lifetime inhalant use for blacks, and the protective effect of high grades was found only for whites. Poor grades were highly predictive of lifetime inhalant use for Asians.

Administration, Inhalation↗
PubMed1999

A comparison of large volume spacer, breath-activated and dry powder inhalers in older people.

AIMS: To see if elderly people can use the breath-activated (Easi-breathe) and dry powder (Turbohaler) inhalers as effectively as the metered-dose inhaler and Volumatic system. METHODS: 102 inhaler-naive patients (aged 75-101, mean 84 years), without cognitive impairment, were randomly allocated one of Easi-breathe, Turbohaler or metered-dose inhaler and Volumatic placebo inhalers. Standardized tuition was done on enrolment and at 6 h review. Inhaler technique was assessed immediately after enrolment tuition and at 6 and 24 h. Assessment was by scoring (0 = poor, 1 = moderate, 2 = perfect) five aspects of technique. RESULTS: Mean total scores were significantly (P < 0.005) higher for Turbohaler and Easi-breathe than metered-dose inhaler and Volumatic on enrolment and 6 h and at 24 h (P < 0.045). Fewer patients achieved excellent scores of 9 or 10 when using metered-dose inhaler and Volumatic. The main difficulties were in assembling the metered-dose inhaler and Volumatic and detecting when the metered-dose inhaler and Volumatic or Easi-breathe was empty. CONCLUSIONS: Breath-activated and dry powder inhalers were more likely to be used correctly than metered-dose inhalers with large volume spacers.

Administration, Inhalation↗
PubMed1999

Inhaled nitric oxide and nifedipine have similar effects on lung cGMP levels in rats.

UNLABELLED: Inhaled nitric oxide (NO) may downregulate the endogenous NO/cyclic guanosine monophosphate (cGMP) pathway, potentially explaining clinical rebound pulmonary hypertension. We determined if inhaled NO decreases pulmonary cGMP levels, if the possible down-regulation is the same as with nifedipine, and if regulation also occurs with the cyclic adenosine monophosphate (cAMP) pathway. Rats were exposed to 3 wk of normoxia, hypoxia (10% O2), or monocrotaline (MCT; single dose = 60 mg/kg) and treated with either nothing (control), inhaled NO (20 ppm), or nifedipine (10 mg x kg(-1) x day(-1). The lungs were then isolated and perfused with physiologic saline. Perfusate cGMP, prostacyclin, and cAMP levels were measured. Perfusate cGMP was not altered by inhaled NO or nifedipine in normoxic or MCT rats. Although hypoxia significantly increased cGMP by 128%, both inhaled NO and nifedipine equally prevented the hypoxic increase. Inhibition of the NO/cGMP pathway with N(G)-nitro-L-arginine methyl ester (L-NAME) decreased cGMP by 72% and 88% in normoxic and hypoxic lungs. Prostacyclin and cAMP levels were not altered by inhaled NO or nifedipine. L-NAME significantly decreased cGMP levels, whereas inhaled NO had no effect on cGMP in normoxic or MCT lungs, suggesting that inhaled NO does not inhibit the NO/cGMP pathway. Inhaled NO decreased cGMP in hypoxic lungs, however, nifedipine had the same effect, which indicates the decrease is not specific to inhaled NO. IMPLICATIONS: High pulmonary pressure after discontinuation of inhaled nitric oxide (NO) may be secondary to a decrease in the natural endogenous NO vasodilator. This rat study suggests that inhaled NO either does not alter endogenous NO or that it has similar effects as nifedipine.

6-Ketoprostaglandin F1 alpha↗
PubMed1995

Cerebral hemodynamics and distribution of left ventricular output during inhalation of nitric oxide.

OBJECTIVES: Inhaled nitric oxide is being utilized as a selective pulmonary vasodilator in the treatment of persistent pulmonary hypertension of the newborn. However, the effects of inhaled nitric oxide on cerebral hemodynamics and distribution of left ventricular output in newborn subjects have not been studied. This study was designed to measure quantitatively the effect of inhaled nitric oxide on the distribution of left ventricular output and on cerebral hemodynamics in a perinatal animal model. DESIGN: Prospective, controlled, experimental study. SETTING: Research laboratory. SUBJECTS: Eight fetal sheep. INTERVENTIONS: Each animal was exposed to three separate study periods: a) mechanical ventilation with low FIO2 (maintaining fetal levels of PaO2); b) inhalation of nitric oxide (20 parts per million) during mechanical ventilation and low FIO2; and c) mechanical ventilation with an FIO2 of 1.0. MEASUREMENTS AND MAIN RESULTS: Left ventricular output and cerebral blood flow were measured with radiolabeled microspheres. Cerebral oxygen delivery and consumption variables were calculated using measurements of arterial and cerebral venous (sagittal sinus) oxygen content. Total left ventricular output did not differ among the three treatment groups: 235 +/- 16 mL/min/kg with hypoxic ventilation; 283 +/- 13 mL/min/kg with nitric oxide inhalation; and 242 +/- 17 mL/min/kg with an FIO2 of 1.0. Lung blood flow increased 2.7-fold with inhaled nitric oxide and 1.6-fold during mechanical ventilation with an FIO2 of 1.0. With a left ventricle microsphere injection, increased lung blood flow is indicative of increased systemic-to-pulmonary shunt across the ductus arteriosus. Whole brain blood flow did not differ between the three groups: 49.6 +/- 6.7 mL/min/100 g with hypoxic ventilation; 46.4 +/- 7.4 mL/min/100 g with nitric oxide inhalation; and 36.4 +/- 3.8 mL/min/100 g with an FIO2 of 1.0. Cerebral oxygen delivery increased during inhalation of an FIO2 of 1.0 when compared with nitric oxide inhalation (p < .007); fractional extraction of oxygen decreased (p < .004 compared with hypoxic ventilation, p < .0005 compared with nitric oxide inhalation). Cerebral oxygen consumption did not differ between the three groups (1.11 +/- 0.12 microns/min/100 g with hypoxic ventilation, 0.95 +/- 0.12 microns/min/100 g with nitric oxide inhalation, and 0.96 +/- 0.08 microns/min/100 g with an FIO2 of 1.0). CONCLUSION: Acute pulmonary vasodilation caused by inhalation of nitric oxide does not change left ventricular output, cerebral blood flow, or cerebral oxygen consumption, despite an increased systemic-to-pulmonary shunt across the ductus arteriosus.

Administration, Inhalation↗
PubMed2001

Uranium and uranium decay series radionuclide dynamics in bone of rats following chronic uranium ore dust inhalation.

The accumulation and release of uranium and some uranium decay chain radionuclides were measured in the bones of rats that had been chronically exposed to inhaled uranium ore dust during the first half (approximately) of their natural adult lifespan. Endochondral bone (femur, tibia, humerus, radius, and ulna), membrane bone (skull roofing bones) and muscle of Sprague-Dawley rats (n = 55) that died at various times up to 65 weeks after the end of chronic inhalation of uranium ore dust aerosol (4.2 h d(-1) for 65 wk) and from age matched controls (n = 10), were analyzed for uranium, 230Th, 226Ra, 210Pb, and 210Po. Overall, during the period of dust inhalation, the nuclides accumulated in the above order of decreasing concentration in dry bone. However, the results demonstrate that there was some differential accumulation of uranium and uranium decay series radionuclides in muscle and two bone types of rats during the chronic inhalation period. The data also show that the bone levels of some, but not all, radionuclides decreased significantly with time after inhalation ceased. Lung uranium concentration at the time of death was a highly significant covariant for temporal changes in the levels of some radionuclides in both endochondral bone and membrane bone, indicating that lung remained a major source of these isotopes for accumulation in these bone types after ore dust inhalation had ceased. For some isotopes, the two bone types behaved differently during the dust inhalation period, and differently again after the dust inhalation ceased. The relative behavior of one bone type compared to the other for a particular isotope during the dust inhalation period did not predict the relative behavior after dust inhalation ceased. However, a faster accumulation of one bone type compared to the other for a particular isotope during the dust inhalation period predicted a faster decrease after dust inhalation ended.

Administration, Inhalation↗
PubMed2006

Pharmacokinetics and pharmacodynamics of high doses of pharmaceutically prepared heroin, by intravenous or by inhalation route in opioid-dependent patients.

A pharmacokinetic-pharmacodynamic study was performed in opioid-dependent patients in the Netherlands, who were currently treated with high doses of pharmaceutically prepared heroin on medical prescription. Besides intravenous heroin, heroin was prescribed for inhalation by "chasing the dragon" method. In this technique, heroin base is heated on aluminium foil, and heroin vapours are inhaled into the lungs. Not much is known about the pharmacokinetics profile and bioavailability of this specific administration method. Therefore, a study was performed on pharmacokinetics and pharmacodynamics of heroin inhalation and intravenous use. Eleven patients who injected heroin and 9 patients who inhaled heroin entered the study. They were on steady-state heroin treatment for at least 12 months. For safety reasons, there was no crossing-over between heroin injection or inhalation. In a double-blind randomised study, 67-100-150% of the regular heroin maintenance dose was administered to each patient. Maximal single heroin dose was 450 mg. Plasma concentrations of heroin and its metabolites 6-monoacetylmorphine, morphine and morphine-glucuronides were analysed using LC-MS-MS. Blood pressure, heart rate, skin temperature and reaction time were assessed. Furthermore, visual analogue scales regarding craving and appreciation of heroin effect were scored by the subjects. Both in inhaling and injecting patients, the areas under curve of heroin and all measured metabolites were linearly related to heroin dose. Mean C(max) of heroin and its metabolites were 2-6 times lower after inhalation, than after intravenous injection. Bioavailability (F) of heroin inhalation was estimated as 52% (95% CI 44-61%). Heroin was rapidly cleared from plasma. Cl/F was 930 l/hr (95% CI 799-1061 l/hr) after intravenous administration, and 1939 l/hr (95% CI 1661-2217 l/hr) after inhalation. Heroin Cl and Vd were correlated to body weight (R(2) 15-19%). Morphine-glucuronides levels were inversely related to creatinine clearance. After heroin administration, the reaction time was significantly prolonged with 28+/-5.3 msec. in injecting and 13+/-4.9 msec. in inhaling patients. Cardiovascular changes were only mild after heroin administration. Craving-scores declined immediately after heroin administration in both administration groups. Subjective heroin effect was rated more positively in heroin inhaling than in injecting patients, despite the lower C(max) levels following heroin inhalation. In both groups, in this blinded study heroin dose increments were more appreciated than dose reductions. Increments of 50% of the regular heroin dose did not cause any serious side effect.

Administration, Inhalation↗
PubMed1998

Urinary N-acetyl-beta-D-glucosaminidase activity in patients with cystic fibrosis on long-term gentamicin inhalation.

OBJECTIVE: To investigate possible renal toxicity of long-term gentamicin inhalation in patients with cystic fibrosis. METHODS: Urinary N-acetyl-beta-D-glucosaminidase (NAG) activity was measured during routine respiratory clinic visits. Outpatient records were reviewed for data on long-term gentamicin inhalation, and parents and patients were interviewed for compliance. Exclusion criteria were irregular gentamicin inhalation, urinary infection or other febrile illness, intravenous aminoglycoside treatment during the previous three months, and diabetes mellitus. Patients were assigned to three groups: group 1, current gentamicin inhalation; group 2, previous gentamicin inhalation that had been stopped at least three months ago; and group 3, never any gentamicin inhalation. RESULTS: 52 patients (34 girls, 18 boys), mean (SD) age 11.5 (5.7) years, entered the study. Patients currently on gentamicin inhalation (n = 20) were significantly younger and had higher urinary NAG activity (0.83 (0.57) U/mmol creatinine) than the 23 patients without gentamicin inhalation (0.26 (0.10) (p = 0.0001) and the nine patients with previous gentamicin inhalation (0.32 (0.15) (p = 0.0125). Twelve patients on current gentamicin inhalation had raised NAG values but all those in groups 2 and 3 had NAG values within the normal range. In patients currently on gentamicin inhalation, there was a positive correlation between urinary NAG activity and cumulative dose of nebulised gentamicin (r = 0.60, p = 0.0049). CONCLUSIONS: Long-term gentamicin inhalation in patients with cystic fibrosis poses a risk of renal toxicity. It is not known whether further treatment might result in more severe renal damage.

Acetylglucosaminidase↗
PubMed2001

Bone mineral density in subjects with mild asthma randomised to treatment with inhaled corticosteroids or non-corticosteroid treatment for two years.

BACKGROUND: Inhaled corticosteroids are clearly beneficial for patients with asthma of moderate severity, but the risks and benefits of using them in patients with milder asthma are less clear. We have compared the change in bone mineral density over 2 years in adults with mild asthma randomised to receive an inhaled corticosteroid or non-corticosteroid treatment. METHODS: Subjects with mild asthma (mean forced expiratory volume in one second (FEV(1)) 86% predicted, mean age 35 years, taking beta agonists only) were randomised to receive inhaled budesonide, inhaled beclomethasone dipropionate, or non-corticosteroid treatment for 2 years in a prospective randomised open study in 19 centres in France, New Zealand, Spain, and the UK. The corticosteroid dose was adjusted according to a written self-management plan. The main outcome measure-change in bone mineral density after 6, 12, and 24 months-was measured "blind". Secondary outcomes included lung function, the relation between change in bone density and inhaled steroid dose and change in biochemical markers of bone metabolism. RESULTS: Of 374 subjects randomised, 239 (64%) completed the study and were included in the analysis. The median daily doses of inhaled budesonide (n=87) and beclomethasone (n=74) were 389 microg and 499 microg, respectively. Subjects treated with an inhaled corticosteroid had better asthma control than those in the reference group (n=78). Change in bone mineral density did not differ between the three groups over the 2 years, nor did it correlate with changes in markers of bone metabolism. The mean change in bone mineral density over 2 years in the budesonide, beclomethasone dipropionate, and reference groups was 0.1%, -0.4%, and 0.4% for the lumbar spine and -0.9%, -0.9%, and -0.4% for neck of the femur. Mean daily dose of inhaled steroid was related to reduction in bone mineral density at the lumbar spine but not at the femoral neck. CONCLUSION: In subjects with mild asthma an inhaled corticosteroid provided better asthma control than alternative non-corticosteroid treatment with no difference in change in bone mineral density over 2 years. The relation between dose of inhaled corticosteroid and change in bone density at the lumbar spine may be due to a direct effect of inhaled corticosteroids on bone. Since inhaled steroid dose is also related inversely to lung function, an effect of asthma severity on bone density was also possible.

Administration, Inhalation↗
PubMed1993

Efficacy and safety of inhaled corticosteroids in asthma. Report of a workshop held in Eze, France, October 1992.

Inhaled glucocorticosteroids have now become first-line therapy for the treatment of chronic asthma in many countries. They are the most effective asthma therapy currently available, and numerous studies have documented their long-term efficacy in asthma control in adults and in children. Inhaled steroids suppress inflammation in asthmatic airways, although their precise molecular mechanism of action is not yet certain. It is likely that steroids affect the transcription of several steroid-responsive genes, and, of particular importance, they may inhibit cytokine gene transcription and cytokine effects, thereby reducing the chronic inflammation in asthmatic airways. Inhaled steroids are now used at a much earlier stage in asthma therapy, and there is a strong argument for their early introduction in both adults and children to prevent asthma morbidity and mortality and possibly the structural changes resulting from uncontrolled chronic inflammation, which may lead to irreversible airflow obstruction in some patients. Of paramount importance is the question of safety as inhaled steroids are likely to be required for a long time. Local side effects caused by oropharyngeal deposition of the inhaled steroid may be reduced by the use of spacer devices and mouthwashing. Systemic side effects caused by gastrointestinal absorption of the fraction deposited in the oropharynx may also be reduced by these devices. There are differences in the systemic bioavailability of the different inhaled steroids currently in use, and inhaled steroids with the lowest bioavailability should be chosen when high doses of inhaled steroids are required for asthma control. Systemic side effects are usually observed only when daily doses of > 800 micrograms are inhaled, and whether effects on very sensitive biochemical indices are relevant to long-term deleterious effects is not yet certain. There is now overwhelming evidence that the doses of inhaled steroids required to control asthma in the majority of adults and children are safe and without systemic side effects. It is important to control asthma with the minimum dose of inhaled steroids possible, however. In the future it may be possible to develop inhaled steroids with even fewer systemic effects if the fraction absorbed from the respiratory tract can be rapidly metabolized in the bloodstream.

Administration, Inhalation↗
PubMed1999

Salbutamol metered-dose inhaler with spacer for hyperkalemia: how fast? How safe?

OBJECTIVE: To determine the efficacy of inhaled salbutamol (rapidly delivered, using a metered-dose inhaler with a spacer device [MDI-S]) in lowering the serum potassium levels in patients with hyperkalemia. DESIGN: A randomized, double-blind, placebo-controlled trial. PATIENTS: Seventeen chronic renal failure patients referred to the Nephrology Unit between October 1, 1997 and March 31, 1998 for hemodialysis were randomized. INTERVENTION AND RESULTS: Group 1 received salbutamol followed by a placebo. Group 2 received a placebo followed by salbutamol. Each patient inhaled 1,200 microg salbutamol or a placebo through an MDI-S within 2 min. Blood samples were obtained repeatedly before inhalation and after 1, 3, 5, 10, and 60 min. The pulse rate and blood pressure were repeatedly measured. Insulin levels were examined in a subset of patients (n = 10) before, and 1 and 5 min following inhalation. Salbutamol's known side effects, palpitation, tachycardia tremor, and headache, were recorded. Potassium levels rose after 1 min following the completion of treatment and then decreased steadily thereafter. A rise of > or = 0.1 mEq/L was seen in 10 of 17 patients (59%) during the treatment period and there was no change (0%) seen during the placebo period (p < 0.0001). Within 3 min after inhalation of salbutamol, potassium levels declined as a function of time. Potassium levels in those patients taking the placebo did not change as a function of time (p < 0.001). The difference between the placebo and the salbutamol-treated periods reached significance after 5 min (p < 0.05). The serum glucose levels rose following inhalation of salbutamol, with a significant rise after 3 min. The heart rate rose significantly within the first 5 min following inhalation. Serum insulin levels remained unchanged 1 min after inhalation; however, after 5 min, a significant elevation was detected. CONCLUSION: Salbutamol inhalation of 1,200 microg, using an MDI-S, has a relatively rapid onset of action that induces a consistent reduction in serum potassium levels, starting 3 to 5 min following delivery. Unexpectedly, a paradoxical elevation was detected in serum potassium levels in the first minutes following inhalation. This effect, although minor (0.15 mEq/L above baseline), may cast some doubt on the role of salbutamol inhalation as the first treatment for excessive hyperkalemia.

Administration, Inhalation↗
PubMed2004

Inhaled corticosteroids, bone mineral density and fracture in older people.

The efficacy of inhaled corticosteroids in the treatment of asthma has been firmly established in a variety of settings. The majority of asthma management plans now recommend the use of inhaled corticosteroids at an early stage. This means that most patients with asthma will be prescribed an inhaled corticosteroid at some point in time and many patients with asthma will use these drugs for several years. Inhaled corticosteroids are also used in the treatment of other conditions, particularly chronic obstructive pulmonary disease (COPD). Since inhaled corticosteroids are absorbed into the systemic circulation, they can have systemic adverse effects, such as suppression of the hypothalamic-pituitary-adrenal axis and increasing the risk of bruising. However, perhaps the greatest concern for patients is whether the regular use of inhaled corticosteroids has an adverse impact on the bone mineral density and increases the risk of fracture. There is now accumulating evidence from epidemiological studies that the use of inhaled corticosteroids is inversely related to bone mineral density in a dose-dependent fashion. However, data from two clinical trials of moderately high doses of inhaled corticosteroids in patients with COPD have produced conflicting results and while the larger study of triamcinolone found a significant impact of this drug on bone mineral density, a smaller study of budesonide found no effect. Epidemiological research into the relationship between inhaled corticosteroids and fracture is at an early stage. To date, only three studies in this area have been reported, all of which have used different approaches to try to minimise the impact of bias and confounding. There is a lack of consistency between the final estimates of the impact of inhaled corticosteroids on fracture risk. However, taken together these data suggest that the short to medium term use of inhaled corticosteroids is associated with a small adverse effect on bone. Doctors and patients need to be aware of this risk and balance it against the known beneficial effects of inhaled corticosteroids.

Administration, Inhalation↗
PubMed2006

Pharmacodynamic and pharmacokinetic considerations in choosing an inhaled corticosteroid.

Inhaled corticosteroids are effective in controlling airway inflammation. Their anti-inflammatory effect is primarily topical, at the site of deposition in the airways. Consequently, traditional pharmacodynamic and pharmacokinetic concepts, which rely on measuring blood concentrations of drug, have limited applicability for evaluating the efficacy of topically acting inhaled corticosteroids. Important factors affecting efficacy of inhaled corticosteroids are: (i) intrinsic properties of the drugs, particularly their affinity for the corticosteroid receptor; and (ii) the newer pharmacodynamic concept of deposition characteristics of the drug formulation. Small particle formulations, especially those developed in the metered-dose inhaler with the new hydrofluoroalkane propellant, deposit to a much greater extent in the lung and may consequently have improved clinical efficacy. Lipid conjugation of inhaled corticosteroids within the lung may allow prolonged duration of effect, enabling once-daily administration. Pharmacodynamic and pharmacokinetic principles probably do not play a role in describing upper airway adverse effects occurring with inhaled corticosteroids. These are probably also determined by intrinsic properties of the drug and deposition characteristics. However, pharmacodynamic and pharmacokinetic principles seem to be important in addressing systemic safety concerns with inhaled corticosteroids. Those inhaled corticosteroids with a longer serum half-life, especially if they have higher affinity for the corticosteroid receptor, may be associated with greater systemic effects. A new pharmacokinetic concept suggests that increased protein binding within the systemic circulation and high systemic clearance of an inhaled corticosteroid may reduce the risk for systemic effects. These new pharmacodynamic and pharmacokinetic concepts provide a useful framework for identifying the characteristics of an inhaled corticosteroid with an improved benefit-to-risk profile. Increased lung deposition and reduced deposition in the upper airway should result in an inhaled corticosteroid with favorable clinical efficacy and a decreased risk for topical upper airway adverse effects. An inhaled corticosteroid with high plasma protein binding and rapid clearance might pose much less risk for systemic adverse effects than currently available drugs in this class.

Administration, Inhalation↗
PubMedDate not supplied

Update on inhaled corticosteroids: safety, compliance, and new delivery systems.

Since the introduction of inhaled beclomethasone, inhaled corticosteroids have revolutionized the treatment of asthma. Inhaled corticosteroids provide the most potent and consistently effective long-term control of asthma. They have become the mainstay of therapy for chronic disease and have been recommended for asthmatics of all severities. During the past two decades, after the introduction of beclomethasone, several new inhaled corticosteroids have been introduced. With more widespread use of these agents, particularly in pediatric patients, concerns about safety have risen. These concerns emanate from the use of higher dose inhaled corticosteroids and higher potency molecules. The side effects of most concern are those that are similar to those associated with systemic corticosteroids. Recently, the U.S. Food and Drug Administration (FDA) issued a class warning of potential growth suppression in some pediatric patients using inhaled corticosteroids. Patient compliance with inhaled corticosteroid therapy is problematic. Some patients think that all inhaled corticosteroid therapy is inherently dangerous because they confuse it with systemic corticosteroid or even anabolic steroid use. Most of the products are available only as metered dose inhalers. Use of these inhalers is difficult and often poorly taught to patients. The two newest inhaled corticosteroids, budesonide and fluticasone, are available as dry powder inhalers with new delivery systems.

Administration, Inhalation↗
PubMed2006

Meta-analysis: efficacy and safety of inhaled insulin therapy in adults with diabetes mellitus.

BACKGROUND: Injection insulin therapy is not readily accepted by patients and many health care providers; therefore, less invasive options for insulin therapy are desirable. PURPOSE: To examine the efficacy, safety, and patient acceptability of inhaled insulin therapy in nonpregnant adults with diabetes mellitus. DATA SOURCES: English-language studies in MEDLINE, the Cochrane Clinical Trials Register (through June 2006), and U.S. Food and Drug Administration review documents of the first formulation of inhaled insulin approved for clinical use. STUDY SELECTION: Randomized, controlled trials of at least 12 weeks' duration that compared inhaled insulin with another active therapy and reported hemoglobin A1c levels in adults with type 1 or type 2 diabetes mellitus. DATA EXTRACTION: Two reviewers independently assessed trials for inclusion and extracted data. Differences were resolved by consensus. DATA SYNTHESIS: Sixteen open-label trials met the inclusion criteria (4023 patients; age range, 18 to 80 years). Among patients with type 1 or type 2 diabetes, there was a small decrease in hemoglobin A1c level from baseline that favored subcutaneous insulin over inhaled insulin (weighted mean difference, 0.08% [95% CI, 0.03% to 0.14%]), although there was no difference in the proportion of participants achieving hemoglobin A1c levels less than 7%. Inhaled insulin lowered hemoglobin A1c levels more (weighted mean difference favoring inhaled insulin, -1.45% [CI, -1.80% to - 1.10%]) compared with fixed doses of oral agents but much less when compared with oral agents titrated to glycemic efficacy (weighted mean difference favoring inhaled insulin, -0.20% [CI, -0.34% to - 0.07%]). Severe hypoglycemia was more likely to occur with inhaled insulin than with oral agents (risk ratio, 3.1 [CI, 1.0 to 9.1]), but there was no increased risk compared with subcutaneous insulin. There was an increased incidence of mild to moderate nonprogressive dry cough in patients treated with inhaled insulin (risk ratio, 3.5 [CI, 2.2 to 5.6]) and a mild decrease in certain pulmonary function testing variables, which did not progress over 2 years. Patients preferred inhaled insulin over subcutaneous insulin. LIMITATIONS: All trials were open label, which may introduce bias. Most of the trials were of 24 weeks' duration or less, limiting assessment of long-term safety. CONCLUSIONS: Inhaled insulin offers an alternative noninvasive option for premeal insulin administration, with glycemic efficacy slightly less than subcutaneous regular insulin and increased patient acceptability. Until long-term safety data are available, inhaled insulin should be reserved for nonpregnant adults with diabetes who are opposed to injections and who would otherwise delay appropriate and timely therapy with insulin.

Administration, Inhalation↗
PubMed2001

Dual components of optimal asthma therapy: scientific and clinical rationale for the use of long-acting beta-agonists with inhaled corticosteroids.

The authors describe the scientific rationale for using an inhaled corticosteroid with an inhaled long-acting beta 2-agonist. They discuss the clinical trials demonstrating that using an inhaled corticosteroid with an inhaled long-acting beta 2-agonist provides greater overall asthma control compared with increasing the dose of inhaled corticosteroid. In addition, they review the clinical trials comparing the addition of a leukotriene modifier to an inhaled corticosteroid versus using an inhaled corticosteroid with an inhaled long-acting beta 2-agonist. Discussion also includes descriptions of trials showing reduced exacerbations of asthma when using an inhaled corticosteroid with an inhaled long-acting beta 2-agonist. Finally, the authors provide evidence for the ability to detect deteriorating asthma when using an inhaled corticosteroid with an inhaled long-acting beta 2-agonist, and they provide a comparison of salmeterol and formoterol, two long-acting beta 2-agonists.

Administration, Inhalation↗
PubMed1994

[Poor technique in the use of inhalation drugs by patients with chronic bronchitis/pulmonary emphysema].

OBJECTIVE: To describe errors in inhaler technique of patients with chronic obstructive pulmonary disease (COPD). SETTING: Outpatient clinic, Department of Pulmonary Medicine, Medisch Spectrum Twente, Enschede, the Netherlands. DESIGN: Descriptive. METHOD: Adult COPD patients who already used an inhaler were asked to demonstrate their inhaler technique. Using a inhaler-specific checklist errors were registered. A division was made into good, adequate and inadequate technique. For each inhaler a selection of critical actions with regard to effective inhaler technique was made. RESULTS: Inhaler technique was assessed in 123 COPD patients. Over one-third of all patients had a very poor inhaler technique, which probably resulted in little or even no drug deposition at all. 42% of the patients performed all essential inhaler actions correctly. For patients with a Diskhaler this was 86%, significantly higher than for the other inhalers, Rotahaler and Turbuhaler, which did not differ much (35% and 46%). Poor inhalation technique leads to insufficient bronchodilating or prophylactic effect, to the prescription of more or additional medication with a higher probability of side effects, and to increased costs. CONCLUSION: The inhalation technique can be improved substantially with a good instruction protocol.

Administration, Inhalation↗
PubMedDate not supplied

Patient satisfaction with the Diskhaler and the Diskus inhaler, a new multidose power delivery system for the treatment of asthma.

To evaluate patient satisfaction with two breath-actuated powder inhalers (Diskhaler and Diskus), investigators asked patients to complete questionnaires as part of a randomized, double-masked, double-dummy, placebo-controlled study of fluticasone propionate powder (500 mg twice daily) in the treatment of chronic persistent asthma. At baseline, patients rated the importance of various inhaler attributes (i.e., ease of use, ease of loading with medication, ease of holding and operating, ease of cleaning, and ease of telling how many doses of medication are left). After 2 weeks of placebo and 6 and 12 weeks of active therapy, patients rated the inhalers on these same attributes. They also rated their general satisfaction with the inhalers and how comfortable they were using them. After 12 weeks, patients also rated the durability and convenience of carrying each device and were asked to indicate which they preferred. Data were available from 213 patients. All seven inhaler attributes measured were considered important by the majority of patients (71% to 91%), contributing to the validity of the patient-rated performance assessments. After 12 weeks of use, 57% to 88% of patients expressed a high level of satisfaction with the performance of the Diskhaler on all attributes; a high level of overall satisfaction (72%) and comfort (79%) was reported with this inhaler. Patients rated the performance of the Diskus inhaler very favorably, with 76% to 96% expressing a high level of satisfaction on all attributes; a high level of overall satisfaction (87%) and comfort (85%) was reported with this inhaler. At end point, 61.4% preferred the Diskus inhaler, 25.4% preferred the Diskhaler inhaler, and 13.2% expressed no preference. These breath-actuated powder inhalers may be acceptable alternatives to traditional metered-dose inhalers for the treatment of patients with asthma.

Adolescent↗
PubMed1999

Efficiency of inhaled nitric oxide as rescue therapy during severe ARDS: survival and factors associated with the first response.

PURPOSE: The purpose of this study was to determine if the response to inhaled nitric oxide (NO) as salvage therapy is an independent factor for survival in adult respiratory distress syndrome (ARDS) patients and to identify the factors that predict the response to inhaled NO during ARDS. MATERIALS AND METHODS: This was a multicenter, 2-year retrospective, clinical study in five university surgical or medical intensive care units, including all consecutive patients with ARDS in whom inhaled NO was tried. Clinical data (medical history, diagnoses), general severity scores (SAPS II, OSF), biological data, radiological and hemodynamic data at admission, at the beginning of the ARDS, and under treatment with inhaled NO were recorded. The NO response was defined as the variation of PaO2/Fio2 ratio before initiation and after 30 minutes of NO inhalation (VarPaO2/FiO2). RESULTS: Ninety-three patients aged 49 +/- 18 years were studied. Mean SAPS II was 45 +/- 16. Before the beginning of inhaled NO, PaO2/Fio2 ratio was 95 +/- 53 mm Hg and lung injury score 2.7 + 0.3. VarPao2/Fio2 when NO was started (11 +/- 4 ppm) was 26 +/- 44.5 mm Hg (median 17 mm Hg). Intensive care unit mortality was 74%. None of the parameters studied were predictors of response to inhaled NO, although there was a tendency for the youngest patients with the more severe hypoxemia to have a better response. Response to first inhaled NO test (VarPaO2/FiO2) was univariately associated with survival (Survivors: 45 +/- 44 mm Hg vs. Nonsurvivors: 20 +/- 43 mm Hg, P = .01), but this difference disappeared after adjusting for other prognostic factors (P = .16) selected by multivariate analysis. Finally, inhaled NO was continued for more than 1 day for 75 patients, and definitively stopped for 18 patients. Intensive care unit mortality (73% vs. 78%) was not different between these groups (P = .25, Log-rank test). CONCLUSIONS: We conclude that (1) efficacy of inhaled NO in improving oxygenation was moderate and difficult to predict, (2) response to first NO inhalation was not associated with prognosis, and (3) treatment of the most severe ARDS patients with inhaled NO did not influenced their intensive care unit survival.

Adult↗