Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient with Mild to Moderate Asthma

Study identifier:LAC-MD-21

ClinicalTrials.gov identifier:NCT01641081

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Phase II, Randomized, Placebo-controlled, Double-blind, Double-dummy, 5-period Complete Crossover study of the Bronchodilator Effects of Formoterol Fumarate Inhalation Powder in Patients with Mild to Moderate Asthma.

Medical condition

asthma

Phase

Phase 2

Healthy volunteers

No

Study drug

Formoterol Fumarate in the Pressair DPI, Low Dose, Formoterol Fumarate in the Pressair DPI, High Dose, Foradil Aerolizer, Low Dose, Foradil Aerolizer, High Dose, Placebo

Sex

All

Actual Enrollment

174

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Jun 2012
Primary Completion Date: 01 Feb 2013
Study Completion Date: 01 Feb 2013

Study design

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

Verification:

Verified 01 Jan 2017 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria