Single dose study to assess efficacy and safety of 4 doses of LAS100977 in chronic obstructive pulmonary disease (COPD) population

Study identifier:M/100977/25

ClinicalTrials.gov identifier:NCT01425814

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A phase IIa, randomised, single dose, double-blind, double-dummy, 6 way complete cross-over, placebo controlled clinical trial to assess the efficacy, safety and tolerability of 4 strengths of LAS100977 QD compared to placebo and an active comparator in patients with stable moderate to severe chronic obstructive pulmonary disease (COPD)

Medical condition

Chronic obstructive pulmonary disease (COPD)

Phase

Phase 2

Healthy volunteers

No

Study drug

LAS100977, Reference, Placebo

Sex

All

Actual Enrollment

87

Study type

Interventional

Age

40 Years +

Date

Study Start Date: 01 Aug 2011
Primary Completion Date: 01 Mar 2012
Study Completion Date: 01 Mar 2012

Study design

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

Verification:

Verified 01 Feb 2017 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria