Bronchodilatory Responses to Formoterol, Ipratropium, and Their Combination in Patients With Stable Copd

Abstract

SUMMARYWe studied 27 patients with stable chronic obstuctive pulmonary disease (COPD) in a randomised, single‐blind, within‐patient, placebo‐controlled clinical study. Each patient was assigned on six separate days to receive one of the following drug regimens in random order: A. 40 μg ipratropium bromide (Atrovent MDI, 20 μg/puff) plus 2 puffs placebo; B. 12 μg formoterol fumarate (Foradil MDI,12 μg/puff) plus 3 puffs placebo; C. 80 μg ipratropium; D. 24 μg formoterol plus 2 puffs placebo; E. 12 μg formoterol plus 40 μg ipratropium plus 1 puff placebo; F. 4 puffs placebo. On each study day, Spirometric indices and vital signs were measured at 5, 10, 15 and 60 minutes, and hourly thereafter up to and including 12 hours after study drug administration. Mean peak FEV1 change (primary endpoint) was maximum with the administration of the combination of ipratropium and formoterol (335.2 ml, SE 24.6), and it differed significantly from the observed peak changes following single administration of the two tested doses of ipratropium (p<0.05 and p<0.05 respectively). Safety and tolerability were satisfactory throughout the study.

The efficacy and safety of additional treatment with short-acting muscarinic antagonist combined with long-acting beta-2 agonist in stable patients with chronic obstructive pulmonary disease: A systematic review and meta-analysis

“…15–21 The peak response of FEV1 from baseline by a single inhalation was an outcome in three reports. 18–20 We judged that there would be indirectness of the results because of the low number of included studies.…”