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
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| Arms | Assigned Interventions |
|---|---|
| Experimental: LAS100977 0.625 μg Single-dose LAS100977 0.625 μg, during double-blind treatment period | Drug: LAS100977 0.625 μg Dry powder inhalation, once-daily, single-dose Drug: Salbutamol placebo Pressurized inhalation, once-daily |
| Experimental: LAS100977 1.25 μg Single-dose LAS100977 1.25 μg, during double-blind treatment period | Drug: LAS100977 1.25 μg Dry powder inhalation, once-daily, single-dose Drug: Salbutamol placebo Pressurized inhalation, once-daily |
| Experimental: LAS100977 2.5 μg Single-dose LAS100977 2.5 μg, during double-blind treatment period | Drug: LAS100977 2.5 μg Dry powder inhalation, once-daily, single-dose Drug: Salbutamol placebo Pressurized inhalation, once-daily |
| Active Comparator: Salbutamol Single-dose salbutamol 400 μg, during double-blind treatment period | Drug: Salbutamol 400 μg Pressurized inhalation suspension, once-daily, single-dose Drug: LAS100977 placebo Dry powder inhalation, once-daily |
| Placebo Comparator: Placebo Placebo to LAS100977, and placebo to salbutamol | Drug: Salbutamol placebo Pressurized inhalation, once-daily Drug: LAS100977 placebo Dry powder inhalation, once-daily |
| Experimental: LAS100977 0.313 μg Single-dose LAS100977 0.313 μg, during double-blind treatment period | Drug: LAS100977 0.313 μg Dry powder inhalation, once-daily, single-dose Drug: Salbutamol placebo Pressurized inhalation, once-daily |
Contacts
Investigators
Principal Investigator
Carol Astbury
AstraZeneca
