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PubMed2006

[How should inhaled corticosteroids be prescribed in asthma?].

The treatment of persistent asthma is based on the concept of a maintenance therapy (inhaled corticosteroids +/- long-acting beta-2-agonists) that is associated with a reliever therapy (short-acting beta-2-agonists). A recent study has suggested a new approach: budesonide/formoterol combination as both maintenance and reliever medication. The patient is told to adjust his medication by himself according to his symptoms. The advantage and potential weakness of this approach will be discussed in the present review.

Administration, Inhalation↗
PubMed1997

Fatal pulmonary edema after nitric acid inhalation.

We report a case of acute inhalation injury of nitric acid in a 56-year old white male. The patient presented conscious and dyspnoic at the emergency department after cleaning a copper chandelier with nitric acid. He had to be intubated 2 h after admission and mechanically ventilated because of fulminant respiratory insufficiency. As all sources of mechanical ventilation failed, extracorporeal membrane oxygenation had to be established 7 h after admission. With the additional use of surfactant and low dose inhalation therapy with nitric oxide (NO), the patient could be stabilised for 3 days and lung function improved temporarily. Despite all efforts the patient died at the fourth day from refactory respiratory failure. Pathologic examination revealed massive pulmonary edema without signs of inflammation. Thus, nitric acid inhalation induced pulmonary edema appears to be a most severe situation in which even most modern therapeutic interventions fail. As, in respect of recent literature and our case no promising therapy for nitric acid inhalation pulmonary edema is available, our efforts have to be directed towards prevention of nitric acid exposure.

Accidents, Home↗
PubMed1994

[Evaluation of aerosol therapy of streptomycin for tracheobronchial tuberculosis].

The clinical features of tracheobronchial tuberculosis are distinct from those of pulmonary tuberculosis in some aspects. Streptomycin (SM) is claimed by some investigators that it has a tendency to promote the development of bronchial stenosis. The purpose of the present investigation is to point out that aerosol therapy of SM is useful for patients with tracheobronchial tuberculosis. Prior to clinical application of the inhalation therapy, we confirmed that the therapy was not harmful. Serum concentration of SM, when inhaled, was measured in 9 volunteers. Before and after administration of SM aerosol, spirograms were examined in 4 volunteers, and no special abnormality was recognized. It seemed that serum concentration of SM after the administration was too low to evoke adverse reactions (less than 3.0 gamma). In 6 patients, blood gases were measured, and no obvious change was observed. In 41 patients with bronchial tuberculosis, bronchofiberscopic examinations were performed twice or more. We observed the ulcerous lesions of bronchial tuberculosis at various stages of healing, and could classify the ulcerous lesions into the following three stages. Active Stage: stage A; ulcer formation without regenerating epithelium, Healing Stage: stage H; ulcer formation with regenerating epithelium, Scarring Stage: stage S; and no ulcer formation. Only the lesions of stage A were observed before treatment. In many patients during the first and second month of treatment, the lesions were at stage A or H. It was found that healing of the lesions of tracheobronchial tuberculosis progressed through the stages A, H, and S, in this order.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Inhalation↗
PubMed2003

Cost-effectiveness of salmeterol in patients with chronic obstructive pulmonary disease: an economic evaluation.

Chronic obstructive pulmonary disease (COPD) is associated with a large economic and social burden. Few economic studies have examined the benefits of inhaled therapy for patients with COPD. This 16-week study examined the cost-effectiveness of salmeterol in this patient group. Patients with a history of COPD were randomised to treatment with salmetrol 50 mcg (229 patients) or placebo (227 patients) twice daily administered by metered-dose inhaler in addition to normal therapy. Forced expiratory volume (FEV1) was measured and patients recorded the impact of their symptoms in a daily diary. Health status was assessed using the St Georges Respiratory Questionnaire. A significantly higher proportion of salmeterol-treated patients had an increase of >15% in FEV1. Salmeterol patients had a higher mean proportion of symptom-free days and nights than those in the placebo group. More salmeterol patients had a clinically significant improvement in health status. Total healthcare costs were increased in the salmeterol group, but hospital and GP visit costs and concurrent COPD medication costs were lower. The reduction in hospital costs was sufficient to offset a substantial portion of the acquisition cost of salmeterol. Addition of salmeterol to COPD patients' current therapy improved lung function, health status at the expense of a modest increase in costs compared with usual therapy.

Administration, Inhalation↗
PubMed1997

Choice of bronchodilator therapy in chronic obstructive pulmonary disease.

The majority of patients with chronic obstructive pulmonary disease may derive benefit from bronchodilator therapy, particularly those patients with severe disease. Currently, three classes of bronchodilator are available: anticholinergics, beta 2-adrenergic agonists and methyl-xanthines. Several factors should be considered when choosing a bronchodilator. Inhaled therapy is generally preferred over oral treatment as the inhaled route reduces systemic exposure to the drug, whereas oral therapy has the advantages of convenience and ease of use. The anticholinergics (e.g. ipratropium bromide) and beta 2-agonists (e.g. salbutamol) are used via the inhaled route and have approximately equivalent acute bronchodilator effects; they differ pharmacokinetically in onset of effect and duration of action and the anticholinergic may be superior in its long-term effects on lung function.

Adrenergic beta-Agonists↗
PubMed2000

High dose inhalation interleukin-2 therapy for lung metastases in patients with malignant melanoma.

BACKGROUND: The lungs are a frequent site of metastasis in patients with melanoma, and this may cause respiratory problems in the terminal phase of the illness. Inhalation interleukin (IL)-2 therapy to the lung has been piloted and appears to be well tolerated. METHODS: Twenty-seven patients were treated with single agent dacarbazine and concurrent high dose inhalation IL-2 36 million IU per day). The patients previously had progressed on chemotherapy, predominately dacarbazine-based regimens. Patients included those with American Joint Committee on Cancer Stage IV melanoma, predominately those with lung metastases, but patients with extrapulmonary metastases also were allowed on the study. RESULTS: Five of the 27 patients experienced a complete pulmonary remission. Eight patients achieved a partial pulmonary remission, and 5 patients experienced stabilization of their disease. Eight patients developed pulmonary metastases. One patient was not evaluable. Four of the five patients who achieved a complete response and seven of the eight patients who achieved a partial response previously were treated with dacarbazine and progressed. There were no responses in extrapulmonary metastases. Side effects of treatment were minimal. The complete responses all were durable with a follow-up of 12 months, whereas patients with partial responses and stable disease progressed when IL-2 was discontinued. CONCLUSIONS: Inhalation therapy with IL-2 for pulmonary metastases from melanoma appears to be safe. The current preliminary study suggests efficacy although concurrent chemotherapy was given, thus confounding results to some extent. Therefore, these results need to be reproduced without concomitant chemotherapy. In addition, a strategy comprised of therapy with IL-2 inhalation until disease progression may prolong responses.

Administration, Inhalation↗
PubMed2004

Cyclodextrins as a potential carrier in drug nebulization.

The inhalation route is widely studied for many drug applications focusing on either local or systemic distributions. One matter of concern is the solubilization of hydrophobic drugs. We have studied the feasibility of using different cyclodextrins (CDs) to elaborate pharmaceutical formulations for the inhalation route and tested the short-term toxicity of such formulations administered by inhalation to C57BL/6 mice. We have shown that HP-beta-CD, gamma-CD, as well as RAMEB aqueous solutions can undergo aerosolization and that the resulting droplet-size ranges are compatible with pulmonary deposition. In vivo, we have demonstrated that short-term exposure to inhaled HP-beta-CD, gamma-CD and RAMEB solutions are non-toxic after assessing bronchoalveolar lavage (BAL), lung and kidney histology, bronchial responsiveness to methacholine and blood urea. The only change noted is a slight increase in lymphocyte count in the BAL after HP-beta-CD and gamma-CD inhalation. We conclude that CDs are useful in significantly enhancing the solubility of apolar drugs with a view to inhalation therapy although an increase in lymphocyte counts in the BAL after CDs inhalations needs further investigations.

Administration, Inhalation↗
PubMed1995

Continuing patient care with metered-dose inhalers.

International guidelines recommend inhaled therapy over oral therapy for asthma because of greater efficacy and safety. Metered-dose inhalers (MDIs) are the delivery system of choice for the majority of patients with asthma. They have been well tried and tested and proven to be safe, reliably delivering a reproducible and precise dose, and account for 85% of the 400 million inhalers currently sold worldwide. Current products using chlorofluorocarbon (CFC) 11/12 as the propellant are being reformulated. Under the Montreal Protocol, CFCs are to be phased out worldwide, though MDIs have been granted temporary exemption, thus far until 1997. Two propellants, hydrofluoroalkane (HFA) 134a and 227, have been identified by the pharmaceutical industry to replace CFCs. However, they have different properties and reformulation has been difficult in relation to surfactants, valves and elastomeric seals. The manufacturing process has been re-engineered to take place at high pressure, because at normal pressure HFA134a is a gas, in contrast with CFC 11 which is a liquid at room temperature. Glaxo has carried out an extensive toxicological assessment of HFA134a and thorough clinical testing has shown it to be well tolerated. To date they have carried out safety and efficacy testing on reformulations of salbutamol, salmeterol and fluticasone propionate (FP). Single-dose studies of salbutamol, 200 micrograms, with HFA134a have been shown to provide equivalent protection against bronchial provocation by histamine in both adults and children with asthma when compared with the currently available CFC preparations. In a subsequent 4-week study, both formulations had similar effects on morning peak flow and the patients believed that the two preparations were equivalent.

Administration, Inhalation↗
PubMed2006

Performance of Turbuhaler((R)) in Patients with Acute Airway Obstruction and COPD, and in Children with Asthma : Understanding the Clinical Importance of Adequate Peak Inspiratory Flow, High Lung Deposition, and Low In Vivo Dose Variability.

The dry-powder inhaler (DPI) Turbuhaler((R)) has been on the market for nearly two decades. Products containing terbutaline, formoterol, budesonide, and the combination budesonide/formoterol are widely used by patients with asthma and COPD. Most patients and physicians find Turbuhaler((R)) easy to use, and local side effects are rare. This is thought to arise from the lack of additives or only small amounts in the formulation, in addition to minimal deposition of the drug in the oropharynx and on the vocal cords during inspiration.The function of Turbuhaler((R)) has frequently been questioned. This article aims to review and clarify some key issues that have been challenged in the literature (e.g. the effectiveness of Turbuhaler((R)) in patients with more restricting conditions), to discuss the importance of lung deposition, and to explain the low in vivo variability associated with Turbuhaler((R)) and the lack of correlation with the higher in vitro variability.Turbuhaler((R)), like other DPIs, is flow dependent to some degree. However, a peak inspiratory flow (PIF) through Turbuhaler((R)) of 30 L/min gives a good clinical effect. These PIF values can be obtained by patients with conditions thought to be difficult to manage with inhalational agents, such as asthmatic children and adult patients with acute severe airway obstruction and COPD. Excellent clinical results with Turbuhaler((R)) in large controlled studies in patients with COPD and acute severe airway obstruction provide indirect evidence that medication delivered via Turbuhaler((R)) reaches the target organ.Due to the large amount of small particles and the moderate inbuilt resistance in Turbuhaler((R)), which opens up the vocal cords during inhalation, Turbuhaler((R)) is associated with a high lung deposition (25-40% of the delivered dose) compared with pressurized metered-dose inhalers (pMDIs) and other DPIs. A good correlation has been found between lung deposition and clinical efficacy. A high lung deposition always results in the best ratio between clinical efficacy and risk of unwanted systemic activity. Studies with Turbuhaler((R)) also show that the in vivo variation in lung deposition is significantly lower compared with a pMDI or, for example, the Diskus((R)) inhaler, and much lower than the in vitro dose variability seen in laboratory tests. Turbuhaler((R)) appears to be a reliable DPI which can be used with confidence by patients with airway diseases, including those with clinical conditions believed to be difficult to manage with inhalational therapy.

Administration, Inhalation↗
PubMed1993

[Assessment of the amount of drug deposited in the lungs of asthmatic children using disodium cromoglycate as the marker].

Disodium cromoglycate (DSCG) is easily absorbed from the airways and lungs, and is excreted unchanged in the urine and bile. Therefore it is possible to estimate the dose of DSCG deposited in the airways and lungs based upon urinary excretion. The urinary concentration of DSCG was measured by the HPLC method in 78 asthmatic children aged 0 to 16 years after they had inhaled 20 mg nebulizer solutions with facemasks. Jet-type nebulizers were used. The mean urinary excretion of DSCG in the patients aged 0, 1, 2 and 3 years from 4-hour urinary collection represented 0.204%, 0.231%, 0.593%, 0.790%, respectively, of the dose administered. In the patients aged 3, 4, 5-6, 7-9 and 10-16 years, from 24-hour urinary collection, the figures were 0.625%, 0.895, 0.855, 1.176%, 1.070%, respectively. The mean dose deposited in the airways and lungs of the age groups 0-1, 2, 3, 4-6, 7-9, and 10-16 years represented approximately 0.5%, 1.4%, 1.4-1.8%, 2.0%, 2.7%, 2.4%, respectively, of the dose administered. Although there was a wide range in the total amount of DSCG deposited in the airways and lungs of asthmatic children, these data seem to provide a useful guide to standardizing the dosing in inhalation therapy.

Administration, Inhalation↗
PubMed1998

Inhaled nitric oxide therapy for adult respiratory distress syndrome.

The selective pulmonary vasodilatory effects of inhaled nitric oxide decrease pulmonary artery hypertension and improve arterial oxygenation in patients with ARDS without causing concomitant systemic vasodilation. Inhaled nitrix oxide therapy may decrease the prevalence of pulmonary edema, pulmonary barotrauma, and oxygen toxicity that occur with current ARDS treatment. The effect of nitric oxide on oxygenation and pulmonary artery pressure may allow more time for the lungs to recover. Initial results of clinical trials are encouraging; however, the impact of inhaled nitric oxide therapy on patients with ARDS remains unclear. Further research is needed to develop safe delivery systems and monitoring techniques for routine clinical use, to determine potential adverse and toxic effects of nitric oxide therapy on patients, and to determine the effects of long-term exposure to nitric oxide among healthcare workers. Concomitant administration of other medications with inhaled nitric oxide should also be investigated.

Administration, Inhalation↗
PubMed1992

Intravenous magnesium for acute asthma: failure to decrease emergency treatment duration or need for hospitalization.

STUDY OBJECTIVE: To evaluate the efficacy of routine early administration of i.v. magnesium to patients with acute asthma. DESIGN: Prospective, randomized clinical trial. SETTING: Urban teaching hospital emergency department. TYPE OF PARTICIPANTS: One hundred twenty consecutive patients aged 18 to 65 years with acute asthma unresponsive to a single albuterol treatment. INTERVENTIONS: All patients received oxygen, 125 mg i.v. methylprednisolone, and hourly albuterol inhalation therapy. The study group also received 2 g i.v. magnesium sulfate infused over 20 minutes. MEASUREMENTS AND MAIN RESULTS: Demographic and clinical characteristics were similar in both groups. Hospitalization was necessary in 13 of 58 patients who received magnesium (22%; 95% confidence intervals [CI], 13% to 32%) and 11 of 62 control patients (17%; 95% CI 10% to 26%; P = .523). Duration of ED treatment in discharged patients was 224 +/- 75 minutes in the magnesium group (95% CI, 208 to 240 minutes) and 228 +/- 90 minutes in the control group (95% CI, 209 to 247 minutes, P = .832). In addition, changes in peak expiratory flow were not statistically different. CONCLUSION: Routine early administration of IV magnesium in acute asthma does not alter treatment outcome.

Acute Disease↗
PubMed1987

[Use of inhalation of ultrasonic aerosols and galvanic current in the treatment of patients with pulmonary tuberculosis].

Multimodality treatment of 83 patients with newly detected destructive forms of pulmonary tuberculosis included the use of inhalation of isoniazid and streptomycin in ultrasonic aerosols in combination with galvanic current. This method was well tolerated by the patients, inhalation agents showed high efficacy: elimination of bacteria and disintegration cavity closing in most of the patients occurred in the first 4 months, i. e. by the end of a course of inhalation therapy. The incorporation of rifampicin in the therapeutic scheme did not result in the improvement of therapeutic results but increased the frequency of side effects (toxic and hepatotoxic). The time course of radionuclide scanning showed that the improvement of the capillary blood flow was more frequently observed in therapy with galvanic current.

Administration, Inhalation↗
PubMed2000

Delivery of fenoterol via Respimat, a novel 'soft mist' inhaler. a randomised, double-blind (within device), placebo-controlled, cross-over, dose-ranging study in asthmatic patients.

BACKGROUND: The phase-out of chlorofluorocarbons (CFCs) for metered dose inhalers (MDIs) has prompted the development of alternative propellants and the design of propellant-free devices for inhalation therapy. OBJECTIVE: This study was carried out to determine the dose of fenoterol inhaled from Respimat (RMT), a new propellant-free soft mist inhaler, which is equivalent in terms of efficacy and safety to 1 puff of either 100 or 200 microg fenoterol inhaled from a conventional CFC-MDI (Berotec). METHODS: Sixty-two asthmatic patients (35 male, 27 female) with a mean baseline FEV(1) of 1.7 liters, corresponding to 55% of the predicted normal value, were randomized at two study centers to 4 of a total of 8 possible treatments: placebo; 12.5, 25, 50, 100, or 200 microg fenoterol via RMT, and 100 or 200 microg fenoterol delivered via the MDI. RESULTS: Fifty-nine patients completed the study as planned. Results of the therapeutic equivalence test for the primary endpoint, average FEV(1) (AUC(0-6))/6 and for the secondary endpoint, peak FEV(1), showed that the 12.5- and 25-microg fenoterol doses administered via RMT were equivalent to the 100 microg fenoterol dose from the MDI. The 50-, 100- and 200-microg fenoterol doses delivered by RMT did not meet the criterion for therapeutic equivalence with the 100-microg dose from the MDI, and if tested for a difference would have been significantly different in favor of RMT. All 5 RMT fenoterol doses were therapeutically equivalent to the MDI 200-microg fenoterol dose. Headache, reported by 4 patients on test days and 2 patients between test days in those randomized to RMT, was the most common adverse event, but the active treatments were generally well tolerated with no dose-dependent increases in incidence or severity of adverse events observed. CONCLUSIONS: The results from the study suggest that safe and efficacious bronchodilation can be obtained from single-dose fenoterol administered via RMT. Use of lower absolute doses to obtain a clinically significant improvement in pulmonary function may be possible because of the increased lung deposition achievable with the novel soft mist inhaler.

Adult↗
PubMed1998

[Clinical and pathophysiologic problems associated with smoke inhalation injury].

Smoke inhalation injury is one of the primary determinants of survival following major burn injury. The primary site of injury in smoke inhalation appears to be the small airway rather than the alveoli, and thus small airway occlusion caused by edema and pseudomembrane formation are the primary mechanisms of progressive hypoxia. Ventilation-perfusion (VA/Q) alterations after smoke inhalation are characterized by increased blood flow to low VA/Q compartments, although an increase in true shunt (VA/Q = 0) was not a consistent finding. This differs considerably from most adult respiratory distress syndrome (ARDS) patients or oleic acid-induced lung edema models, in which an increase in true shunt is the major mechanism of hypoxia. Such differences lead to different responses to nitric oxide (NO) inhalation therapy, and NO does not improve oxygenation and outcome in patients with smoke inhalation injury. In the treatment of inhalation injury, meticulous removal of pseudomembrane by fiberoptic bronchoscopy is essential, the use of high concentrations of oxygen should be avoided since it can cause absorption atelectasis. High-frequency percussive ventilation is a suitable treatment for inhalation injury, as it improves oxygenation and facilitates removal of pseudomembrane.

Burns, Inhalation↗
PubMedDate not supplied

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↗
PubMed2000

Does nitric oxide prevent oxidative mediated lung injury?

UNLABELLED: The US Food and Drug Administration recently approved nitric oxide (NO) inhalation therapy for newborn infants >34 wk of gestation with hypoxic respiratory failure associated with pulmonary hypertension. In clinical trials, this therapy has reduced the need for extracorporeal membrane oxygenation. It has not reduced mortality, however. A body of accumulating data indicates that NO may act as an antioxidant as well as a prooxidant, depending on a number of known and unknown factors, e.g. the concentration of NO itself and the concentration of other oxidants. In low doses, NO is an antioxidant and in high doses its prooxidant effects are more pronounced. In this issue of Acta Paediatrica, new information regarding this question has come to light. Turanlanthi et al. have found that NO in relatively high doses induces free radical mediated injury in the lungs of 10-wk-old Wistar rats, while in combination with hyperoxia it attenuates the oxidative stress of hyperoxia alone. Recently, it has also become clear that NO acts as a second messenger activating a number of cytokines and inducing apoptosis. There therefore seems to be a close relation between NO, oxidative stress, regulation of growth and inflammation. For these reasons, long-term follow-up studies of newborn infants treated with NO inhalation are needed. So far, NO therapy has not been successful in premature infants. CONCLUSIONS: NO inhalation has a number of both short-term and long-term potential adverse effects, and is still at the experimental stage in premature infants. Consequently, there is a need for further clinical studies monitoring also the long-term consequences of this therapy.

Free Radical Scavengers↗