Study identifier:M/100977/202
ClinicalTrials.gov identifier:NCT01425801
EudraCT identifier:N/A
CTIS identifier:N/A
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.
asthma
Phase 2
No
LAS100977 0.313 μg, LAS100977 0.625 μg, LAS100977 1.25 μg, LAS100977 2.5 μg, Salbutamol 400 μg, Salbutamol placebo, LAS100977 placebo
All
62
Interventional
18 Years - 70 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Apr 2018 by AstraZeneca
AstraZeneca
-
No locations available
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 |