Formoterol Dose Ranging Study (ACHIEVE Duaklir USA Phase IIb).

2016-06-13 17:08:21 | BioPortfolio


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).


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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Chronic Obstructive Pulmonary Disease (COPD)


Formoterol fumarate (6 μg), Formoterol furmarate (20 μg), Placebo for formoterol fumarate, Formoterol fumarate (12 μg), Formoterol fumarate (40 μg)


Research Site
United States


Not yet recruiting



Results (where available)

View Results


Published on BioPortfolio: 2016-06-13T17:08:21-0400

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PubMed Articles [897 Associated PubMed Articles listed on BioPortfolio]

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Comparison of the effect of beclometasone/formoterol in asthma patients after methacholine-induced bronchoconstriction: a non-inferiority study using metered dose versus dry powder inhaler.

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Medical and Biotech [MESH] Definitions

A pharmaceutical preparation of budesonide and formoterol fumarate that is used as an ANTI-ASTHMATIC AGENT and for the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

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An ADRENERGIC BETA-2 RECEPTOR AGONIST with a prolonged duration of action. It is used to manage ASTHMA and in the treatment of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.

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