Efficacy and safety of ipratropium bromide-albuterol compared with albuterol in patients with moderate-to-severe asthma: a randomized controlled trialReport as inadecuate




Efficacy and safety of ipratropium bromide-albuterol compared with albuterol in patients with moderate-to-severe asthma: a randomized controlled trial - Download this document for free, or read online. Document in PDF available to download.

BMC Pulmonary Medicine

, 16:65

Asthma and allergic disorders

Abstract

BackgroundMany patients with asthma require frequent rescue medication for acute symptoms despite appropriate controller therapies. Thus, determining the most effective relief regimen is important in the management of more severe asthma. This study’s objective was to evaluate whether ipratropium bromide-albuterol metered-dose inhaler CVT-MDI provides more effective acute relief of bronchospasm in moderate-to-severe asthma than albuterol hydrofluoroalkaline ALB-HFA alone after 4 weeks.

MethodsIn this double-blind, crossover study, patients who had been diagnosed with asthma for ≥1 year were randomized to two sequences of study medication -as needed- for symptom relief 1–7 day washout before second 4-week treatment period: CVT-MDI-ALB-HFA or ALB-HFA-CVT-MDI. On days 1 and 29 of each sequence, 6-hour serial spirometry was performed after administration of the study drug. Co-primary endpoints were FEV1 area under the curve AUC0–6 and peak post-dose forced expiratory volume in 1 s FEV1 response change from test day baseline after 4 weeks. The effects of -as needed- treatment with ALB-HFA-CVT-MDI were analyzed using mixed effect model repeated measures MMRM.

ResultsA total of 226 patients, ≥18 years old, with inadequately controlled, moderate-to-severe asthma were randomized. The study met both co-primary endpoints demonstrating a statistically significant treatment benefit of CVT-MDI versus ALB-HFA. FEV1 AUC0-6h response was 167 ml for ALB-HFA, 252 ml for CVT-MDI p <0.0001; peak FEV1 response was 357 ml for ALB-HFA, 434 ml for CVT-MDI p <0.0001. Adverse events were comparable across groups.

ConclusionsCVT-MDI significantly improved acute bronchodilation over ALB-HFA alone after 4 weeks of -as-needed- use for symptom relief, with a similar safety profile. This suggests additive bronchodilator effects of β2-agonist and anticholinergic treatment in moderate-to-severe, symptomatic asthma.

Trial registrationClinicalTrials.gov No.: NCT00818454; Registered November 16, 2009.

KeywordsRandomized controlled trial Moderate-to-severe asthma Ipratropium bromide Albuterol hydrofluoroalkaline Ipratropium bromide-albuterol metered-dose inhaler Anticholinergic-β2-agonist Bronchodilation As-needed Acute symptom relief AbbreviationsACQasthma control questionnaire

AEadverse event

ALB-HFAalbuterol hydrofluoroalkaline

AQLQasthma quality of life questionnaire

AUCarea under the curve

BMIbody mass index

CFCchlorofluorocarbon

COPDchronic obstructive pulmonary disease

CVTipratropium bromide-albuterol sulfate

ECGelectrocardiogram

FASfull analysis set

FEV1forced expiratory volume in 1 second

FVCforced vital capacity

ICSinhaled corticosteroid

LABAlong-acting β2-agonist

MDImetered-dose inhaler

MMRMmixed effect model repeated measures

PEFpeak expiratory flow

SABAshort-acting β2-agonist

Electronic supplementary materialThe online version of this article doi:10.1186-s12890-016-0223-3 contains supplementary material, which is available to authorized users.

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Author: James F. Donohue - Robert Wise - William W. Busse - Sandra Garfinkel - Valentina B. Zubek - Mo Ghafouri - Raymond C. Ma

Source: https://link.springer.com/



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