Single dose study to assess efficacy, safety and tolerability of LAS100977 in asthmatic patients.

Study identifier:M/100977/202

ClinicalTrials.gov identifier:NCT01425801

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 doses of LAS100977 QD compared to placebo and an active comparator in patients with persistent asthma.

Medical condition

asthma

Phase

Phase 2

Healthy volunteers

No

Study drug

LAS100977 0.313 μg, LAS100977 0.625 μg, LAS100977 1.25 μg, LAS100977 2.5 μg, Salbutamol 400 μg, Salbutamol placebo, LAS100977 placebo

Sex

All

Actual Enrollment

62

Study type

Interventional

Age

18 Years - 70 Years

Date

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

Study design

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

Verification:

Verified 01 Apr 2018 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria