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PubMed1998

Safety and efficacy of a high cumulative dose of salbutamol inhaled via Turbuhaler or via a pressurized metered-dose inhaler in patients with asthma.

An open, crossover and randomized study was carried out to compare the safety and efficacy of salbutamol inhaled using the dry-powder inhaler Turbuhaler, and using a pressurized metered-dose inhaler (pMDI). Twelve patients with moderate to severe asthma, aged 47-68 years, were included in the study. On two separate days, patients received a total dose of 1600 micrograms of salbutamol administered in a cumulative dose fashion: 100, 100, 200, 400 and 800 micrograms at 3-min intervals. Salbutamol inhaled via Turbuhaler caused a larger decrease in serum potassium concentration than did salbutamol inhaled via pMDI. The estimated relative dose potency of the hypokalaemic effect of salbutamol Turbuhaler vs salbutamol pMDI was 2.0 with a 95% confidence interval of 1.3-3.6. Turbuhaler caused a small (but statistically significantly greater than with pMDI) increase in heart rate, QTc interval and tremor. Blood pressure was unaffected by the treatments. No adverse events of clinical relevance were reported. The estimated relative dose potency of the bronchodilating effect (FEV1) of salbutamol Turbuhaler vs salbutamol pMDI was 3.0 with a 95% confidence interval of 1.8-5.8. In conclusion, salbutamol inhaled via Turbuhaler was more potent and seemed to have a better therapeutic ratio than salbutamol inhaled via pMDI. Both treatments were equally well tolerated.

Adrenergic beta-Agonists↗
PubMed2000

Improved delivery of ipratropium bromide using Respimat (a new soft mist inhaler) compared with a conventional metered dose inhaler: cumulative dose response study in patients with COPD.

Respimat (RMT) is a reusable, propellant-free, soft mist inhaler (SMI), a novel device for inhalation therapy. We conducted a three-period cross-over study to evaluate the safety and efficacy of cumulative doses of ipratropium bromide inhaled from RMT (Two dose levels) or from a pressurized metered dose inhaler (MDI), in 36 patients with chronic obstructive pulmonary disease (COPD). The bronchodilator effect of ipratropium bromide was greater when administered via RMT (10 or 20 microg per puff, given double-blind within device, to total doses of 160 or 320 microg) than via MDI (20 microg per puff, total dose 320 microg). The bronchodilator effects of the 160 and 320 microg doses delivered via RMT were similar. Cumulative ipratropium bromide doses of 320 microg given via MDI or RMT and 160 microg given via RMT produced similar safety profiles. Between 45 min after the first drug inhalation and 45 min after the final dose, greater bronchodilatory effect was obtained from half the cumulative dose of ipratropium (RMT 10 microg per puff) when compared with the MDI (20 microg per puff). Therefore, ipratropium bromide delivered by RMT is as safe as, and can be more effective than, the MDI on acute administration in patients with COPD.

Administration, Inhalation↗
PubMed1997

Cost-effectiveness analysis of a dry powder inhaler (Turbuhaler) versus a pressurised metered dose inhaler in patients with asthma.

In an open randomised parallel-group study, 1004 patients with asthma in 7 countries were randomised to receive asthma treatment via 2 different kinds of inhalers: an aerosol pressurised metered dose inhaler (pMDI) and a dry powder inhaler (Turbuhaler). The patients were treated for 52 weeks with inhaled corticosteroids and/or inhaled beta 2-agonists. All patients were considered adequately treated with inhaled corticosteroids and/or inhaled beta 2-agonists via pMDI before inclusion in the study. Healthcare utilisation variables were attached to the case record forms of the patients, thus making an economic analysis possible. Because of the difficulty of comparing costs between countries, each country was analysed separately. Canadian patients constituted the largest subpopulation (445 patients) and were therefore used in this analysis. From the analysis, we concluded that the effectiveness of treatment (measured as the number of exacerbations and days with exacerbation) was significantly better for patients treated via Turbuhaler than via a pMDI (p = 0.03). Furthermore, the total annual costs of treatment were, on average, $Can331 less (p < 0.01) for patients using Turbuhaler than for those using a pMDI (mainly due to lower costs for hospitalisation and medication). The cost differences between inhaled corticosteroids and inhaled beta 2-agonists were significantly in favour of treatment via Turbuhaler (p < 0.01). Thus, the results of this study suggest that treatment via Turbuhaler is a cost-effective strategy in patients with asthma in Canada.

Adrenergic beta-Agonists↗
PubMed1999

New formulation metered dose inhaler increases breath alcohol levels.

A new, chlorofluorocarbon-free metered dose inhaler containing salbutamol, with small amounts of ethanol as a co-solvent, has recently been released. We evaluated the effect on breath alcohol levels of two inhalations from this metered dose inhaler. In 10 volunteers, breath alcohol levels rose to 17.9 micrograms 100 ml-1 breath after an inhalation with a good technique, and to 35 micrograms 100 ml-1 breath (the current legal limit for driving in the UK) after a poor inhalation. Breath alcohol levels were reduced by the use of a spacer device, and in all cases fell to near zero after 2 min. In patients who have just used this type of metered dose inhaler, breath alcohol measurements should be defferred for at least 2 min.

Adult↗
PubMed2000

Acceptance of the Accuhaler, a multi-dose powder inhaler, among asthmatic patients: a comparison with the pressurized metered-dose inhaler.

This study aimed to evaluate dry powder inhaler naive asthmatic patients' perception and preference of the Accuhaler, a multidose dry powder inhaler and the pressurized metered dose inhaler (pMDI). After the first instruction, 66.7% of 48 patients enrolled in the study could demonstrate the correct use of the Accuhaler. When the patients were asked to compare the pMDI and the Accuhaler after using the Accuhaler to administer salmeterol for 4 weeks, the Accuhaler scored significantly better than the pMDI for the following features: knowing how many doses are left, presence of an attached cover, taste, instruction for use, attractiveness, ease of use, ease of holding, shape, and comfortable mouthpiece. The pMDI scored better to the Accuhaler in terms of size. More patients preferred the Accuhaler than the pMDI; the presence of a dose counter and perceived ease of use were the main reasons cited for their preference for the Accuhaler.

Administration, Inhalation↗
PubMed2002

Modulite: a means of designing the aerosols generated by pressurized metered dose inhalers.

Although popular, the pressurized metered dose inhaler generates coarse, fast moving clouds so that the fraction reaching the lung is small. These shortcomings can be redressed by Modulite which permutes the following variables: the non-volatile components of a solution formula, the actuator orifice geometry, the volume of the metered solution and the vapour pressure of the propellants. This permits the design of aerosols with chosen particle size and plume speed. This facilitates co-ordination of dose generation with inspiration, reduces oropharyngeal deposition and provides a mechanism for targeting drug delivery to different parts of the lung. These principles are exemplified by designing an HFA-propelled beclometasone dipropionate product which closely matches existing products which use chlorofluorocarbons.

Aerosol Propellants↗
PubMed1983

Fenoterol inhalation powder as an alternative to treatment with the metered dose inhaler.

Nine adult asthmatics took part in a cumulative dose response comparison of fenoterol (Berotec) inhalation powder and fenoterol metered dose inhaler. The study was carried out as a double-blind investigation using a double-dummy technique. No significant difference was observed in the lung function, in tremor or pulse rate on comparison of the two modes of administration. It is concluded that fenoterol inhalation powder is an effective and freon-free alternative to the metered dose inhaler.

Adult↗
PubMed1998

Effects of inhaled fluticasone propionate administered with metered dose inhaler and spacer in mild to moderate croup: a negative preliminary report.

Beneficial effects of treatment of viral croup with inhaled corticosteroids and administered with a jet-nebulizer have been reported in recent years. To facilitate such therapy at home and avoid hospitalization, the administration of inhaled corticosteroids with a metered dose inhaler (MDI) with a holding-chamber was studied as a potential alternative. In a hospital-based prospective, double-blind, randomized study, 17 children admitted with croup were treated with either fluticasone propionate MDI (2,000 microg with the Babyhaler spacer) or placebo. The primary outcome variable was the croup symptom score recorded from 0 up to 24 hours. Secondary outcome variables were the need for administration of nebulized corticosteroids with a nebulizer, the need for intubation, and the duration of hospitalization. The administration of the drug with an MDI and spacer was well tolerated in each child. In all children the clinical course was favorable, without any significant differences between the actively treated and placebo-treated group. One child needed additional use of inhaled corticosteroids with a jet nebulizer, despite treatment with fluticasone. Mean duration of hospitalization was 2.6 (1-4) and 2.4 (1-4) days for treatment with fluticasone and placebo, respectively. No undesirable side effects of treatment were reported. In conclusion, this study did not demonstrate therapeutic benefits of fluticasone propionate when administered with an MDI and a spacer compared with placebo. We hypothesize that the lack of effect is probably due to the inadequate deposition of adequate inhaled corticosteroids in the upper airways.

Administration, Inhalation↗
PubMed2000

Transition to CFC-free metered dose inhalers--into the new millennium.

Metered dose inhalers (MDIs) are the most popular vehicle for drug delivery into the lungs and some 500 million are manufactured each year. All MDIs marketed prior to 1995 contained chlorofluorocarbons (CFC) as a propellant. These are implicated in the depletion of stratospheric ozone and, except for specific exemptions, their production has been banned since 1996 under the terms of the Montreal Protocol. Hydrofluoroalkanes have been identified as suitable alternatives for MDI propellants but their physico-chemical properties differ significantly from CFCs and an extensive redevelopment and testing programme has been required to demonstrate the safety, quality and efficacy of HFA containing MDIs. Hydrofluoroalkanes contribute to global warming but the benefit to human health through continued MDI availability currently outweighs the environmental concern. Several HFA-MDIs have reached the market and the transition to replace existing CFC-MDIs is now underway.

Aerosol Propellants↗
PubMed1988

High speed photographic analysis of aerosols produced by metered dose inhalers.

The design of pressurized metered dose inhalers (MDI) used to assess asthma is variable. We have examined the aerosol spray flumes generated by four commercially available MDI products using high speed video photography. For this purpose a moulded jacket was designed which could hold the inhaler in an immovable position during actuation. Fresh inhalers were fitted in the jacket after thorough shaking and three successive actuations 30 s apart were filmed with a high speed video camera (200 frames s-1). The aerosol, ejected at high velocity into calm room air, was seen to have a 'jet' phase followed by a 'cloud' phase as a result of particle dispersion. Filming was continued till the flume could no longer be visualized on the TV monitor. High speed photography was used to record flumes seen on the video monitor, to enable characterization of flume appearance, dimensions and mean velocity.

Aerosols↗
PubMed1994

Misuse of metered-dose inhalers in hospitalized patients.

Metered-dose inhalers (MDIs) have been associated with a high rate of misuse. Medical personnel also have a poor understanding of MDI technique. Hospitalized patients had their MDI technique observed before and after a series of inservices were provided to hospital personnel on correct MDI use. The rate of misuse did not change with 55 of 72 (76 percent) patients making errors in the first group before, and 45 of 55 (82 percent) patients making errors in the second group after staff education (p = 0.46). The average number of errors per patient was 2.39 in group 1 and 2.45 in group 2 (p = 0.93). Alternatives to deal with this high rate of MDI misuse are discussed.

Administration, Inhalation↗
PubMed1993

A comparison of albuterol administered by metered dose inhaler (and holding chamber) or wet nebulizer in acute asthma.

BACKGROUND: Comparative studies of albuterol by wet nebulizer or metered dose inhaler have tested fixed doses of medications. We compared the dose-response relationship to albuterol by wet nebulization or metered dose inhaler in acute asthma. METHODS: Randomized, double-blind, placebo-controlled trial. Patients with acute asthma received either albuterol, 0.4 mg, by metered dose inhaler (and holding chamber) or albuterol, 2.5 mg, by wet nebulizer every 30 min until maximal bronchodilation. Forty patients (forced expiratory volume in 1 s [FEV1]: 1.15 +/- 0.43 L; 36 +/- 12 percent predicted) received metered dose inhaler and 40 others (FEV1: 1.08 +/- 0.52 L; 35 +/- 16 percent predicted) received wet nebulization. RESULTS: Twenty-six patients (65 percent) receiving metered dose inhaler and 30 (75 percent) receiving wet nebulization achieved maximal bronchodilation after two doses. Almost all reached maximal bronchodilation by four doses. The FEV1 improved by 0.72 +/- 0.49 L for metered dose inhaler and 0.68 +/- 0.61 L for wet nebulizer (p = 0.71). A significant linear relationship was seen in both groups (metered dose inhaler r = 0.94; wet nebulizer r = 0.98) between the log dose of albuterol and change in FEV1. About 1/6 the wet nebulizer dose of albuterol was needed to achieve similar response to the metered dose inhaler. CONCLUSIONS: Albuterol by metered dose inhaler provided similar bronchodilation to that achieved by wet nebulization in patients with acute asthma. The cumulative dose-response technique is applicable in the emergency department setting and is helpful in comparing the relative utility of various bronchodilator regimens.

Acute Disease↗
PubMed2001

Systematic review of clinical effectiveness of pressurised metered dose inhalers versus other hand held inhaler devices for delivering beta (2 )agonists bronchodilators in asthma.

OBJECTIVES: To determine the clinical effectiveness of pressurised metered dose inhalers compared with other hand held inhaler devices for delivering short acting beta(2) agonists in stable asthma. DESIGN: Systematic review of randomised controlled trials. DATA SOURCES: Cochrane Airways Group specialised trials database (which includes hand searching of 20 relevant journals), Medline, Embase, Cochrane controlled clinical trials register, pharmaceutical companies, and bibliographies of included trials. TRIALS: All trials in children or adults with stable asthma that compared the pressurised metered dose inhaler (with or without a spacer device) against any other hand held inhaler device containing the same beta(2) agonist. RESULTS: 84 randomised controlled trials were included. No differences were found between the pressurised metered dose inhaler and any other hand held inhaler device for lung function, blood pressure, symptoms, bronchial hyperreactivity, systemic bioavailability, inhaled steroid requirement, serum potassium concentration, and use of additional relief bronchodilators. In adults, pulse rate was lower in those using the pressurised metered dose inhaler compared with those using Turbohaler (standardised mean difference 0.44, 95% confidence interval 0.05 to 0.84); patients preferred the pressurised metered dose inhaler to the Rotahaler (relative risk 0.53, 95% confidence interval 0.36 to 0.78); hydrofluoroalkane pressurised metered dose inhalers reduced the requirement for rescue short course oral steroids (relative risk 0.67, 0.49 to 0.91). CONCLUSIONS: No evidence was found to show that alternative inhaler devices are more effective than standard pressurised metered dose inhalers for delivering acting beta(2 )agonist bronchodilators in asthma. Pressurised metered dose inhalers remain the most cost effective delivery devices.

Adrenergic beta-Agonists↗
PubMed2004

Efficacy and safety of mometasone furoate dry powder inhaler vs fluticasone propionate metered-dose inhaler in asthma subjects previously using fluticasone propionate.

OBJECTIVE: To compare the efficacy and safety of mometasone furoate dry powder inhaler (DPI) administered once daily in the evening with fluticasone propionate metered-dose inhaler (MDI) administered twice daily. METHODS: An 8-week, randomized, open-label, parallel-group study compared mometasone furoate DPI, 400 microg every evening (1 puff daily), with fluticasone propionate MDI, two 125-microg puffs twice daily, in 167 adults and adolescents with moderate persistent asthma previously using fluticasone propionate. The primary efficacy variable was the change in forced expiratory volume in 1 second (FEV1) from baseline to the end point. Variables such as response to therapy and subject satisfaction with the inhaler devices were also analyzed. RESULTS: Improvement in FEV1 was noted at the week 2 visit with both treatments. This improvement was maintained at the 4- and 8-week visits and at the end point for both groups. The mean percent change in FEV1 from baseline to the end point was 4.58% with mometasone furoate DPI and 6.98% with fluticasone propionate MDI (P = .35). At the end point, physicians rated 62% of the mometasone furoate DPI group as "improved" or "much improved" compared with 47% of the fluticasone propionate MDI group (P = .007). A significantly greater proportion of subjects in the mometasone furoate DPI group "liked the inhaler a lot" vs subjects in the fluticasone propionate MDI group (46.8% vs 22.4%; P = .01). Both treatments were well tolerated. CONCLUSION: Mometasone furoate DPI, 400 microg every evening, provided comparable efficacy as fluticasone propionate MDI, two 125-microg puffs twice daily, in subjects with moderate persistent asthma previously treated with fluticasone propionate.

Adolescent↗
PubMed2004

Efficacy, tolerability, and effect on asthma-related quality of life of formoterol bid via multidose dry powder inhaler and albuterol QID via metered dose inhaler in patients with persistent asthma: a multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group study.

BACKGROUND: Inhaled beta(2)-agonists are widely used in asthma treatment. The design limitations of pressurized metered dose inhalers (pMDIs) have prompted the development of dry powder inhalers (DPIs) for the delivery of asthma medications. OBJECTIVE: The goal of this study was to evaluate the efficacy, tolerability, and effect on asthma-related quality of life (QOL) of a long-acting beta(2)-adrenoreceptor agonist, formoterol, delivered via multidose DPI, compared with albuterol delivered via pMDI or placebo in adolescents and adults with persistent asthma. METHODS: This multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel-group study was conducted in outpatient clinics at 18 US centers. Adolescents and adults with persistent asthma received formoterol 10 pg BID via multidose DPI, albuterol 180 microg QID via pMDI, or placebo for 12 weeks. The primary efficacy variable was the 12-hour AUC of forced expiratory volume in 1 second (FEV(1)) after 12 weeks treatment. Secondary efficacy variables included asthma-related QOL, asthma symptom scores, rescue medication use, and other pulmonary function measures. RESULTS: A total of 239 patients (147 females, 92 males; age range, 13-85 years) with persistent asthma were enrolled (formoterol, n = 80; albuterol, n = 79; placebo, n = 80). Formoterol delivered via the multidose DPI resulted in clinically relevant and statistically significant increases in 12-hour AUC of FEV(1) after 12 weeks of treatment compared with albuterol pMDI and placebo (P < 0.019 and P < 0.001, respectively). Asthma-related QOL (total score) was significantly improved with formoterol treatment compared with placebo (P < 0.015). Nocturnal asthma symptom scores significantly improved with formoterol compared with albuterol and placebo (P < 0.001 and P < 0.003, respectively) and rescue medication use was significantly less with formoterol compared with albuterol and placebo (P < 0.004 and P < 0.002, respectively). Treatment with formoterol was well tolerated. CONCLUSIONS: In this study of adolescents and adults with persistent asthma, 12 weeks of treatment with formoterol 10 microg BID delivered via a multidose DPI provided significantly greater 24-hour bronchodilation compared with albuterol and placebo and resulted in significant improvements in asthma-related QOL compared with placebo. Formoterol was well tolerated in these patients.

Administration, Inhalation↗
PubMed2000

Comparison of the effect on bronchial hyperresponsiveness of beclomethasone dipropionate administered via a novel multidose dry-powder inhaler or a conventional pressurised metered dose inhaler.

BACKGROUND: Treatment with inhaled corticosteroids improves symptoms and reduces bronchial hyperresponsiveness (BHR) associated with asthma. Delivery of drugs into the lung is dependent on the inhaler device. Furthermore, environmental concerns regarding the use of chlorofluorocarbon propellants in pressurised inhalers and patient acceptability of inhaler devices both influence the extent of use of different delivery systems. OBJECTIVES: To compare the efficacy of beclomethasone dipropionate (BDP) administered via a novel multidose dry-powder inhaler (DPI) and a conventional pressurised metered-dose inhaler (pMDI) with spacer in patients with BHR. METHODS: A randomised, double-blind, crossover study was carried out in a group of 27 patients (aged 19-55 years) with a clinical diagnosis of reversible airway disease, who demonstrated BHR to methacholine (PD(20) < or =6.4 mg). Each patient received BDP (< or =2 mg/day) via the DPI or pMDI, for periods of 4 weeks. The randomised treatment periods were preceded by 3-week washout periods when no corticosteroid was used. Five clinic visits marked the start and end of each study phase. The primary efficacy endpoint was BHR as defined by the pharmacodynamic parameter, PD(20), which was determined at the start and end of each treatment period. Clinical endpoints including lung function, symptoms and adverse events were also evaluated. RESULTS: Both treatments caused a significant decrease in BHR (p<0.05 vs. pre-treatment values). Mean +/- SD changes in log PD(20) were: DPI 0.59+/-1.29; pMDI 0.59+/-0.94 mg. There was no statistically significant difference between treatments and no evidence of a carry-over effect between treatments on BHR. Clinical efficacy and safety parameters also demonstrated no statistically significant treatment differences, and patients found the DPI easier to use. CONCLUSION: Efficacy of BDP in reducing BHR is comparable via the DPI and pMDI plus spacer.

Administration, Inhalation↗