Formoterol dose ranging study (ACHIEVE Duaklir USA Phase IIb)

Study identifier:D6571C00002

ClinicalTrials.gov identifier:NCT02796651

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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.

Medical condition

Chronic obstructive pulmonary disease - COPD

Phase

Phase 2

Healthy volunteers

No

Study drug

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

Sex

All

Actual Enrollment

132

Study type

Interventional

Age

40 Years - 130 Years

Date

Study Start Date: 30 Jun 2016
Primary Completion Date: 07 Dec 2016
Study Completion Date: 07 Dec 2016

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2018 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

PAREXEL

Inclusion and exclusion criteria