scholarly journals Dose-response Protective Effect of Salbutamol on Methacholine Airway Responsiveness using Pressurized Metered Dose Inhalers and Turbuhalers

1998 ◽  
Vol 5 (2) ◽  
pp. 119-123 ◽  
Author(s):  
Albert G Wong ◽  
Paul M O'Byrne ◽  
Christer Lindbladh ◽  
Mark D Inman ◽  
Elisabeth Ståhl ◽  
...  
Keyword(s):  
Protective Effect ◽  
Forced Expiratory Volume ◽  
Airway Responsiveness ◽  
Dose Inhaler ◽  
Metered Dose Inhalers ◽  
Double Blind ◽  
Beta Agonists ◽  
Metered Dose ◽  
Dose Dependent Fashion ◽  
Dose Dependent

The purpose of this study was to estimate the relative dose potency of salbutamol Turbuhaler compared with salbutamol pressurized metered dose inhaler (pMDI) with respect to the protective effect against methacholine bronchoconstriction. Twenty-three asthmatic subjects with stable asthma participated in the study. Baseline forced expiratory volume in 1 s (FEV1) was 70% or more of predicted, and baseline methacholine provocative concentration causing a 20% fall in FEV1(PC20) was 4 mg/mL or less. The design was randomized, double-blind, double-dummy, crossover and placebo controlled and was conducted over seven study days. On each study day, the subjects inhaled 50 µg or 100 µg of salbutamol via Turbuhaler, 100 µg, 200 µg, 400 µg or 800 µg of salbutamol via pMDI, or placebo in randomized order. PC20was determined 30 mins after inhalation. Increasing doses of salbutamol pMDI increased the PC20in a dose-dependent fashion from 3.9 mg/mL after placebo to 13.3 mg/mL after pMDI 100 µg, 19.0 mg/mL after 200 µg, 32.6 mg/mL after 400 µg, and 35.1 mg/mL after 800 µg. The half-maximum response dose for pMDI (ED50) was 104 µg. Salbutamol Turbuhaler 50 µg increased the PC20to 10.0 mg/mL and 100 µg to 12.6 mg/mL. Salbutamol pMDI 200 µg provided significantly greater protection to methacholine than pMDI 100 µg or Turbuhaler 100 µg and significantly less protection than pMDI 400 µg (P<0.05). This study demonstrates that the relative protective dose potency of inhaled beta-agonists can be determined by comparing their effects on methacholine airway responsiveness. The estimated relative protective dose potency for salbutamol Turbuhaler in comparison with pMDI was 1.38 (95% CI 0.67 to 2.87) at 50 µg and was 0.96 (95% CI 0.56 to 1.64) at 100 µg.

scholarly journals Improvements in lung function with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler versus dual therapies in patients with COPD: a sub-study of the ETHOS trial

2021 ◽  
Vol 15 ◽  
pp. 175346662110343 ◽  
Author(s):  
Klaus F. Rabe ◽  
Fernando J. Martinez ◽  
Dave Singh ◽  
Roopa Trivedi ◽  
Martin Jenkins ◽  
...  
Keyword(s):  
Lung Function ◽  
Area Under The Curve ◽  
Forced Expiratory Volume ◽  
Phase Iii ◽  
Dose Inhaler ◽  
Chronic Obstructive ◽  
Severe Exacerbation ◽  
Double Blind ◽  
Metered Dose ◽  
Formoterol Fumarate

Background: In the phase III, 52-week ETHOS study in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), triple therapy with budesonide/glycopyrrolate/formoterol fumarate (BGF), at two inhaled corticosteroid dose levels, resulted in significantly lower moderate/severe exacerbation rates versus glycopyrrolate/formoterol fumarate (GFF) and budesonide/formoterol fumarate (BFF). Here, we report results from the ETHOS pulmonary function test (PFT) sub-study, which assessed lung function in a subset of ETHOS patients. Methods: ETHOS (NCT02465567) was a randomized, double-blind, multi-center, parallel-group study in patients with moderate to very severe COPD who had experienced ⩾1 moderate/severe exacerbation in the previous year. Patients received BGF 320/18/9.6 µg, BGF 160/18/9.6 μg, GFF 18/9.6 µg, or BFF 320/9.6 µg twice daily via a single metered dose Aerosphere inhaler for 52 weeks. A subset of patients participated in the 4-hour PFT sub-study; primary endpoints were change from baseline in morning pre-dose trough forced expiratory volume in one second (FEV1) versus GFF and FEV1 area under the curve from 0 to 4 hours (AUC0–4) versus BFF at week 24. Results: The PFT modified intent-to-treat population included 3088 patients (mean age 64.4 years; mean reversibility post-albuterol 16.7%; mean post-albuterol FEV1% predicted 42.8). BGF 320/18/9.6 µg and 160/18/9.6 µg significantly improved morning pre-dose trough FEV1 at week 24 versus GFF ( p ⩽ 0.0035 for both). Improvements in trough FEV1 were also observed at week 52 for BGF 320/18/9.6 µg and 160/18/9.6 µg versus GFF ( p ⩽ 0.0005 for both). For FEV1 AUC0–4 at week 24, BGF 320/18/9.6 µg and 160/18/9.6 µg showed significant improvements versus BFF ( p < 0.0001 for both). Improvements were maintained at week 52 ( p < 0.0001). Conclusions: BGF 320/18/9.6 µg and 160/18/9.6 µg significantly improved trough FEV1 versus GFF and FEV1 AUC0–4 versus BFF at week 24. The lung function benefits with both doses of BGF were maintained following 52 weeks of treatment. The reviews of this paper are available via the supplemental material section.

Effects of bronchodilator particle size in asthmatic patients using monodisperse aerosols

2003 ◽  
Vol 95 (5) ◽  
pp. 2106-2112 ◽  
Author(s):  
Omar S. Usmani ◽  
Martyn F. Biddiscombe ◽  
Julia A. Nightingale ◽  
S. Richard Underwood ◽  
Peter J. Barnes
Keyword(s):  
Particle Size ◽  
Plasma Potassium ◽  
Forced Expiratory Volume ◽  
Dose Inhaler ◽  
Therapeutic Drug ◽  
Double Blind ◽  
Asthmatic Patients ◽  
Metered Dose ◽  
Aerosol Particle Size ◽  
Forced Expiratory Flow

Aerosol particle size influences airway drug deposition. Current inhaler devices are inefficient, delivering a heterodisperse distribution of drug particle sizes where, at best, 20% reaches the lungs. Monodisperse aerosols are the appropriate research tools to investigate basic aerosol science concepts within the human airways. We hypothesized that engineering such aerosols of albuterol would identify the ideal bronchodilator particle size, thereby optimizing inhaled therapeutic drug delivery. Eighteen stable mildly to moderately asthmatic patients [mean forced expiratory volume in 1 s (FEV1) 74.3% of predicted] participated in a randomized, double-blind, crossover study design. A spinning-top aerosol generator was used to produce monodisperse albuterol aerosols that were 1.5, 3, and 6 μm in size, and also a placebo, which were inhaled at cumulative doses of 10, 20, 40, and 100 μg. Lung function changes and tolerability effects were determined. The larger particles, 6 and 3 μm, were significantly more potent bronchodilators than the 1.5-μm and placebo aerosols for FEV1and for the forced expiratory flow between exhalation of 25 and 75% of forced vital capacity. A 20-μg dose of the 6- and 3-μm aerosols produced FEV1bronchodilation comparable to that produced by 200 μg from a metered-dose inhaler. No adverse effects were observed in heart rate and plasma potassium. The data suggest that in mildly to moderately asthmatic patients there is more than one optimal β2-agonist bronchodilator particle size and that these are larger particles in the higher part of the respirable range. Aerosols delivered in monodisperse form can enable large reductions of the inhaled dose without loss of clinical efficacy.

scholarly journals Salmeterol and Airway Response to Allergen

1997 ◽  
Vol 4 (1) ◽  
pp. 37-40 ◽  
Author(s):  
Donald W Cockcroft ◽  
Veronica A Swystun ◽  
Rajesh Bhagat ◽  
Sanjay Kalra
Keyword(s):  
Inhaled Corticosteroids ◽  
Day Treatment ◽  
Tertiary Care ◽  
Forced Expiratory Volume ◽  
Airway Responsiveness ◽  
Double Blind ◽  
Regular Treatment ◽  
Beta Agonists ◽  
Randomized Crossover Trial ◽  
Airway Response

BACKGROUND: Regular treatment with inhaled salbutamol (seven to 14 days) increases airway responsiveness to allergen.OBJECTIVE: To assess the effect of salmeterol 50 µg twice daily for six days on the early asthmatic response to allergen (PC15).DESIGN: Double-blind, randomized, crossover trial comparing salmeterol with placebo (twice daily over six days) with one week or more washout. Forced expiratory volume in 1 s (FEV1) and allergen PC15were measured 36 h after each treatment was discontinued.SETTING: Tertiary care out-patient bronchoprovocation laboratory.SUBJECTS: Fourteen atopic asthmatics well controlled with (n=5) or without (n=9) inhaled corticosteroids. Subjects did not use inhaled beta-agonists for at least two weeks before and during the trial.RESULTS: FEV1was slightly but significantly lower 36 h after the last dose of salmeterol versus placebo (3.28±0.83 versus 3.40±0.88 L, P=0.032). Airway responsiveness to allergen increased by about half a doubling concentration (log10PC152.71±0.61 versus 2.85±0.61, P=0.047).CONCLUSION: A six-day treatment course of salmeterol 50 μg twice daily resulted in a slight decline in FEV1and a modest increase in airway response to allergen at 36 h.

Evaluation of a Breath Operated Powder Inhaler

1988 ◽  
Vol 16 (3) ◽  
pp. 201-203 ◽  
Author(s):  
G. M. Pover ◽  
C. G. Langdon ◽  
S. R. Jones ◽  
C. Fidler
Keyword(s):  
Single Dose ◽  
Crossover Study ◽  
Forced Expiratory Volume ◽  
Dose Inhaler ◽  
Metered Dose Inhaler ◽  
Double Blind ◽  
Bronchodilator Response ◽  
Dose Effects ◽  
Metered Dose ◽  
Response Change

A randomized, double-blind, double-dummy crossover study on 42 asthmatics was carried out to compare the single dose effects of salbutamol administered from the widely used metered dose inhaler and a breath operated system (Diskhaler®). The bronchodilator response (change in forced expiratory volume in the first second) was almost identical for the two systems. The Diskhaler® system however, since it is breath operated, obviates the need for hand–breath coordination.

Evaluation of levalbuterol metered dose inhaler in pediatric patients with asthma: a double-blind, randomized, placebo- and active-controlled trial

2006 ◽  
Vol 22 (6) ◽  
pp. 1217-1226 ◽  
Author(s):  
William E. Berger ◽  
Henry Milgrom ◽  
David P. Skoner ◽  
Kenneth Tripp ◽  
Merdad V. Parsey ◽  
...  
Keyword(s):  
Pediatric Patients ◽  
Controlled Trial ◽  
Dose Inhaler ◽  
Metered Dose Inhaler ◽  
Double Blind ◽  
Metered Dose

Bronchodilators in critical illness

2016 ◽  
Author(s):  
Rajiv Dhand ◽  
Michael McCormack
Keyword(s):  
Drug Delivery ◽  
Dry Powder Inhaler ◽  
Dose Inhaler ◽  
Positive Pressure ◽  
Therapeutic Effects ◽  
Artificial Airway ◽  
Beta Agonists ◽  
Metered Dose ◽  
Wide Variability ◽  
Device Placement

Inhaled beta-agonists and anticholinergic agents, as well as systemically administered methylxanthines, are frequently employed to achieve bronchodilation in critically-ill patients. Inhaled agents are given by pressurized metered dose inhaler (pMDI), nebulizer, or dry powder inhaler. In ventilator-supported patients, aerosolized agents are generally only administered by pMDI or nebulizer. The ventilator circuit, artificial airway, and circuit humidity complicate the delivery of aerosolized agents, and there is a wide variability in drug delivery efficiency with various bench models of mechanical ventilation. Aerosolized drug by pMDI is affected by the use of spacer devices, synchronization of pMDI actuation and ventilator breath delivery, and appropriate priming of the pMDI device. The efficiency of aerosolized drug delivery by jet nebulization is also affected by device placement in the circuit, as well as by a number of other factors. Several investigators have demonstrated comparable efficiency of aerosol delivery with mechanically-ventilated and ambulatory patients when careful attention is given to the technique of administration. Appropriate administration of aerosolized bronchodilators in patients receiving invasive or non-invasive positive pressure ventilation produces significant therapeutic effects.

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