NCT02796651

Formoterol Dose Ranging Study (ACHIEVE Duaklir USA Phase IIb)

A Randomized, Double-blind, Placebo-controlled, Incomplete Unbalanced, Crossover Study to Assess the Efficacy and Safety of Three Doses of Formoterol Fumarate in Pressair® Compared With Perforomist® Inhalation Solution (20 and 40 μg Open-label) in Moderate to Severe COPD Patients With Reversible Airway Disease.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 40 Years – 130 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease - COPD

Interventions

Type	Name	Description
DRUG	Formoterol fumarate (6 μg)	Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI)
DRUG	Formoterol furmarate (20 μg)	Oral Inhalation (via a standard jet nebulizer connected to an air compressor.
DRUG	Placebo for formoterol fumarate	Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI)
DRUG	Formoterol fumarate (12 μg)	Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI)
DRUG	Formoterol fumarate (40 μg)	Oral Inhalation (via a standard jet nebulizer connected to an air compressor.

Timeline

• Start date: 2016-06-30
• Primary completion: 2016-12-07
• Completion: 2016-12-07
• First posted: 2016-06-13
• Last updated: 2018-02-07
• Results posted: 2018-02-07

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study