Conditions: Chronic Obstructive Pulmonary Disease - COPD
Keywords: Perforomist Pressair COPD Cigarette smoking Formoterol fumarate long-acting β2-adrenergic agonists (LABA) long-acting muscarinic antagonists (LAMA)
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 132
Healthy volunteers: no

Brief summary:
To assess the bronchodilation of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID) administered via Pressair® compared to placebo and to open-label nebulized formoterol fumarate (20 μg and 40 μg).

Detailed description:
This is a prospective, randomized, double-blind, 5-period incomplete unbalanced crossover, placebo and active comparator (open-label) controlled, multicenter clinical trial to assess the efficacy and safety of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) BID administered via Pressair® compared to placebo and to open-label formoterol fumarate (20 μg BID and 40 μg single dose) administered as an inhalation solution via a standard jet nebulizer (with a mouthpiece) connected to an air compressor (Perforomist® Inhalation Solution). The drug product is an inhalation powder comprising of micronized aclidinium bromide and micronized formoterol fumarate with α-lactose monohydrate as the carrier, presented in a breathactuated device-metered dry-powder inhaler (DPI). It has been approved under the trademarks of Genuair® and/or Pressair® in some territories.

Arms:
arm 1: Participants received formoterol fumarate 6 μg administered via Pressair twice daily (BID). arm 2: Participants received formoterol fumarate 12 μg administered via Pressair BID. arm 3: Participants received formoterol fumarate 24 μg administered via Pressair BID. arm 4: Participants received placebo to formoterol fumarate administered via Pressair BID. arm 5: Participants received Perforomist inhalation solution and were instructed to take one puff from each of the two Pressair inhalers or to inhale one vial from the Perforomist 20 μg inhalation solution BID for 7 ± 1 consecutive days. arm 6: Participants received Perforomist 40 μg (2 vials of Performist 20 μg) as a single dose of administration.

Interventions: intervention 1: Formoterol fumarate (6 μg) intervention 2: Formoterol furmarate (20 μg) intervention 3: Placebo for formoterol fumarate intervention 4: Formoterol fumarate (12 μg) intervention 5: Formoterol fumarate (40 μg)
Intervention descriptions: intervention 1: Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI) intervention 2: Oral Inhalation (via a standard jet nebulizer connected to an air compressor. intervention 3: Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI) intervention 4: Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI) intervention 5: Oral Inhalation (via a standard jet nebulizer connected to an air compressor.

Protocol document: