Bronchodilating effects of salbutamol from a novel inhaler Airmax TM (original) (raw)
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Medical Journal of Australia, 1989
Twenty-one patients with mild-to-moderately-severe asthma participated in a placebo-controlled, double-blind, cross-over, randomized bronchodilator study of 200 Ilg of salbutamol (Glaxo) and 200 Ilg of salbutamol in the form of salbutamol sulphate (Riker;SO-Illand 2SiJl valves) that were administered by metered-dose inhalers. The mean baseline forced expired volumes in one second (FEY1) were similar for the four separate study days. The three active treatments caused a significantly-greater FEY1 response than did placebo for four hours (P<O.OS) and no difference was found between the treatments (P> O.OS). The power of the study was 7S% with a clinically-significant difference in the FEY 1 response of 2S%. The administration of 200 Ilg of salbutamol (Glaxo) caused the same FEY1 response as did that of 400 Ilg of salbutamol at the end of that study day (P> O.OS), but both 200-llg doses of salbutamol sulphate (Riker) caused a smaller FEY 1 response than did the 400 Ilg of salbutamol sulphate (P<O.OS). These observations indicate that no clinically-significant difference occurs between the bronchodilator effects of salbutamol and those of salbutamol sulphate which is administered as 200 Ilg of salbutamol equivalent, with different propellant mixtures, dispersal agents and valvular systems.
Journal of Allergy and Clinical Immunology, 1995
Background: New formulations of non-chlorofluorocarbon-containing propellants for pressurized metered-dose inhaler delivery systems must be developed in response to the forthcoming ban on chlorofluorocarbon (CFC) production. Objective: This study compared the bronchodilator effects of 100, 200, and 300 lag (base equivalent) of salbutamol in a novel CFC-free propellant system (Airomir in the 3M CFC-Free System; 3M Pharmaceuticals, St. Paul, Minn.; 108 IN of salbutamol sulfate or 90 IN of salbutamol base equivalent per inhalation) with that of 100 and 200 ixg of salbutamol base in a conventional CFC propellant system (Ventolin, CFC-11/12; Allen and Hanburys, Division of Glaxo Inc., Research Triangle Park, N.C.; 90 tN of salbutamol base per inhalation) and placebo. Methods: Twenty-six patients with chronic, stable asthma, who had a forced expiratory volume in 1 second (FEV1) between 50.0% and 75.0% of predicted normal value, entered this randomized, double-blind, double-dummy, 6-period, crossover study. FEV 1 was measured before and at multiple time points (ranging from 10 to 480 minutes) after administration of one, two, and three inhalations of salbutamol/CFC-free (100, 200, and 300 IN); one and two inhalations of salbutamol/CFC ; and placebo. Safety parameters included adverse events, heart rate, blood pressure, physical examinations, electrocardiograms, and clinical laboratory tests. Parametric analysis of variance models appropriate for a 6-period crossover design were used, along with multiple comparisons according to Tukey's method. Results: All active treatments produced significantly (p < O. 0001) greater bronchodilation than placebo. The bronchodilator effect, as measured by FEV z (peak percent change, peak as a percent of predicted value, duration, and area under the curve) after two inhalations of salbutumol/CFC-free was clinically comparable to two inhalations of salbutamol/CFC, with no clinically meaningful differences in safety parameters between the two delivery systems or between different dose levels. Conclusion: These results suggest that salbutamol/CFC-free may offer a suitable alternative for salbutamol/CFC when the need arises to change from CFC-containing salbutamol products. (J ALLERGY CLIN IMMUNOL 1995;96.'50-6.)
Journal of Allergy and Clinical Immunology, 1995
Background: New formulations of non-chlorofluorocarbon-containing propellants for pressurized metered-dose inhaler delivery systems must be developed in response to the forthcoming ban on chlorofluorocarbon (CFC) production. Objective: This study compared the bronchodilator effects of 100, 200, and 300 lag (base equivalent) of salbutamol in a novel CFC-free propellant system (Airomir in the 3M CFC-Free System; 3M Pharmaceuticals, St. Paul, Minn.; 108 IN of salbutamol sulfate or 90 IN of salbutamol base equivalent per inhalation) with that of 100 and 200 ixg of salbutamol base in a conventional CFC propellant system (Ventolin, CFC-11/12; Allen and Hanburys, Division of Glaxo Inc., Research Triangle Park, N.C.; 90 tN of salbutamol base per inhalation) and placebo. Methods: Twenty-six patients with chronic, stable asthma, who had a forced expiratory volume in 1 second (FEV1) between 50.0% and 75.0% of predicted normal value, entered this randomized, double-blind, double-dummy, 6-period, crossover study. FEV 1 was measured before and at multiple time points (ranging from 10 to 480 minutes) after administration of one, two, and three inhalations of salbutamol/CFC-free (100, 200, and 300 IN); one and two inhalations of salbutamol/CFC ; and placebo. Safety parameters included adverse events, heart rate, blood pressure, physical examinations, electrocardiograms, and clinical laboratory tests. Parametric analysis of variance models appropriate for a 6-period crossover design were used, along with multiple comparisons according to Tukey's method. Results: All active treatments produced significantly (p < O. 0001) greater bronchodilation than placebo. The bronchodilator effect, as measured by FEV z (peak percent change, peak as a percent of predicted value, duration, and area under the curve) after two inhalations of salbutumol/CFC-free was clinically comparable to two inhalations of salbutamol/CFC, with no clinically meaningful differences in safety parameters between the two delivery systems or between different dose levels. Conclusion: These results suggest that salbutamol/CFC-free may offer a suitable alternative for salbutamol/CFC when the need arises to change from CFC-containing salbutamol products. (J ALLERGY CLIN IMMUNOL 1995;96.'50-6.)
Respiratory Medicine, 2007
Background: Salbutamol, the most widely used short-acting b 2-agonist, consists of a racemic mixture of equal amounts of two enantiomers, (R)-salbutamol and (S)-salbutamol. The bronchodilator effects of salbutamol are attributed entirely to (R)-salbutamol (levosalbutamol), while (S)-salbutamol has been shown to possess bronchospastic and pro-inflammatory effects both in vitro and in vivo studies. Levosalbutamol, the (R)enantiomer of salbutamol is currently available only in a liquid formulation for use via a nebulizer. Recently, levosalbutamol to be administered via a pressurized metered dose inhaler (pMDI) has been developed. Aims: To compare the time-dependent bronchodilator responses of single doses of 100 mcg levosalbutamol and 200 mcg racemic salbutamol administered via a pMDI in subjects with stable mild-to-moderate bronchial asthma over a period of 6 h. Methods: Single doses of 100 mcg levosalbutamol, 200 mcg salbutamol and placebo were administered with a pMDI in 30 stable asthmatic subjects in a randomized, double-blind, placebo-controlled, three-way cross over study. Forced expiratory volume in 1 s (FEV 1) and forced vital capacity (FVC) were measured at baseline, and over 6 h post-study drug administration.
European Journal of Clinical Pharmacology, 1999
In this double-blind, placebo-controlled, crossover study we compared the bronchoprotective effects of formoterol 12 g inhaled via an HFA-134a inhaler (Modulite ® HFA) versus a CFC and a DPI device in 38 patients with mildto-moderate persistent asthma. All three formoterol preparations signifi cantly increased methacholine PD 20 and FEV 1 and improved small airway function parameters compared with placebo (p ! 0.001). No signifi cant differences were observed between formoterol formulations. In conclusion, Modulite ® HFA formoterol was found to be an effective and well tolerated treatment in patients with asthma, with comparable effi cacy to current formoterol preparations.
CHEST Journal, 2000
To determine the protective effect of salbutamol, 100 g, inhaled by different devices (pressurized metered-dose inhaler [pMDI; Ventolin; GlaxoWellcome; Greenford, UK], pMDI ؉ spacer [Volumatic; GlaxoWellcome], or breath-activated pMDI [Autohaler; 3M Pharmaceuticals; St. Paul, MN]) on bronchoconstriction induced by methacholine. Design: Randomized, double-blind, cross-over, placebo-controlled study. Patients: Eighteen subjects with stable, moderate asthma, asymptomatic, receiving regular treatment with salmeterol, 50 g bid, and inhaled beclomethasone dipropionate, 250 g bid, in the last 6 months, with high hyperreactivity to methacholine (baseline provocative dose of methacholine causing a 20% fall in FEV 1 [PD 20 ] geometric mean [GM], 0.071 mg). Subjects were classified into two groups: subjects with incorrect (n ؍ 5) pMDI inhalation technique, and subjects with correct (n ؍ 13) inhalation technique. Methods and measurements: After cessation of therapy for 3 days, all subjects underwent four methacholine challenge tests, each test 1 week apart, each time 15 min after inhalation of salbutamol, 100 g (via pMDI, pMDI ؉ spacer, or Autohaler), or placebo. The protective effect on methacholine challenge test was evaluated as the change in the PD 20 , and expressed in terms of doubling doses of methacholine in comparison with placebo treatment. Results: The PD 20 was significantly higher after salbutamol inhalation than after placebo inhalation, but no significant difference was observed among the three different inhalation techniques. Only when salbutamol was inhaled via pMDI ؉ spacer, PD 20 was slightly but not significantly higher (pMDI GM, 0.454 mg; pMDI ؉ spacer GM, 0.559 mg; and Autohaler GM, 0.372 mg; not significant [NS]) than other inhalation techniques. Similar results (mean ؎SEM) were obtained with doubling doses of methacholine (pMDI, 2 ؎ 0.47; pMDI ؉ spacer, 3 ؎ 0.35; and Autohaler, 2.4 ؎ 0.40; NS). No significant difference was found among techniques when subjects with correct or incorrect inhalation technique were separately considered. Conclusions: Our data show that the protective effect of salbutamol, 100 g, on methacholineinduced bronchoconstriction is not affected by the different inhalation techniques, although inhalation via pMDI ؉ spacer tends to improve the bronchoprotective ability of salbutamol. These data confirm the clinical efficacy of salbutamol, whatever the device, and the patient's inhalation technique.
Canadian Respiratory Journal, 1997
STUDY OBJECTIVE: To compare two dosing regimens of salbutamol in acute asthma.DESIGN: Prospective randomized double-blind trial.SETTING: Urban emergency department.TYPE OF PARTICIPANTS: Patients who presented to the emergency department with moderate to severe asthma.INTERVENTIONS: All patients had pulmonary function testing and were randomized to group A (control; n=25) or group B (experimental; n=23). Group A (control) patients received salbutamol 2.5 mg delivered by wet aerosol at 0, 1 and 2 h (total dose 7.5 mg). At 20, 40, 80 and 100 mins a placebo aerosol was given. Group B patients received salbutamol 5 mg at 0 min and one-third the initial dose every 20 mins for a total of six doses by wet aerosol (total dose 15 mg).RESULTS: There were no differences in age, sex, preadmission medications or initial forced expiratory volume in 1 s (FEV1) between the groups. Forty-eight patients completed the study. Both groups of patients improved with mean absolute change in FEV1of 700 mL in...
The aim of the present study was to demonstrate the effect of inhalation-flow, inhalationvolume and number of inhalations on aerosol-delivery of inhaled-salbutamol from two different dry powder inhalers (DPIs) in both healthy-subjects and chronic obstructive pulmonary disease (COPD) patients. Relative pulmonary-bioavailability and systemic-bioavailability of inhaled-salbutamol, delivered by Diskus and Aerolizer, was determined in 24-COPD patients and 24-healthy subjects. The healthy-subjects and the COPD-patients participated in the study for 7 days in which they received 4 study doses of 200 lg salbutamol (one slow-inhalation, two slow-inhalations, one fast-inhalation, and two fast-inhalations) in four alternative days with 24 hr washout period after each dose. Two urine-samples were collected from each study subjects. The first was provided 30 min post inhalation (USAL0.5), as an index of relative pulmonary-bioavailability, and the second was pooled to 24 hr post inhalation (USAL24), as an index of systemic-bioavailability. Fast-inhalation resulted in significantly higher USAL0.5 and USAL24 than slow-inhalation (p˂ 0.05) after one-inhalation in both healthy-subjects and COPD-patients but there was no significant difference between slow and fast-inhalation after two-inhalations. One-inhalation resulted in significantly higher USAL0.5 and USAL24 in healthy-subjects compared to COPD-patient at both slow and fastinhalation (p˂0.05) except USAL0.5 with Diskus at slow-inhalation there was no significant difference. Also, two-inhalations resulted in significantly higher USAL0.5 and USAL24 compared to one-inhalation at slow-inhalation only (p˂0.05). No significant difference was found between Aerolizer and Diskus except in USAL0.5 of one slow-inhalation in both healthsubjects and COPD-patients (p ¼ 0.048 and 0.047, respectively). Device-formula relation is present at low inhalation-flow since Diskus resulted in significantly higher USAL0.5 and USAL24 in healthy-subjects compared to COPD-patient at slow inhalation than Aerolizer. It is essential to inhale-twice and as hard and deep as possible from each dose when using DPI especially with COPD-patients having poor inspiratory efforts such as elderly patients and children.
Background: Asthma is a chronic inflammatory disease of the airway with relapse and remission. There are different forms or variants of asthma eg: Intermittent Asthma, Persistent Asthma. Loss of control of any form or variant of asthma is termed as Acute exacerbation: which may cause mild to life threatening attack. Salbutamol inhalation is the key to control the acute attack. With its own advantages and disadvantages different delivery systems have been developed for asthma medications. Efficacy assessment compared between pMDI with Spacer and DPI(Aerolizer) about bronchodilator response in mild to moderate acute exacerbation of Asthma in young patients(19 years to 40 years) at out patient basis. Patients with severe acute exacerbation were excluded. Methods: This observational study was done at outpatient basis in Brahmanbaria Medical College Hospital, Concept Hospital, Feni & National Hospital, Dagonbhuiyan, Feni, Bangladesh and the sample was 100 Acute Asthma patients over a period of six months from January 2017 to July 2017. The patients were selected by pre-diagnosed Asthma patients as Acute exacerbation of Asthma by typical symptoms eg: Mild exacerbation: patient was dyspnoeic but can complete sentences and Moderate exacerbation; patient was more dyspnoeic and can,t complete a sentence in one breath. Initial peak expiratory flow rate (PEFR) was recorded. Randomly distributed two groups of equal number of patients received 500 micro-gm of salbutamol either by MDI with spacer and DPI (Aerolizer).Subsequent Subjective assessment were done by patient,s clinical status and objective follow-up were done by peak flow meter to record PEFR. Results: The subjective and objective improvement were observed with pMDI with spacer and DPI evident by symptoms and PEFR. Conclusion: Dry powder inhaler is better compliant in younger patient as it is effort dependent with greater Peak Inspiratory Flow Rate (PIFR) usually 60L/min or higher, measured by In-Check DIAL. However this study showed that in acute Asthma where there is loss of control equal amount of drug delivered by MDI with spacer showed better bronchodilator response.