Clinical Trial to Assess the Protective Effect of the Fixed Drug Combination of Disodium Cromoglycate Plus Reproterol in Comparison to the Single Components and Placebo in Adults With Exercise Induced Asthma Randomised, Placebo-controlled, Double-blind, Crossover, Multicentre Study (AERIA)

NCT00777348 Phase 2 COMPLETED

This is a multicentre, randomised, double-blind, placebo-controlled, 4-way cross-over study. At each study visit a standardised treadmill test will be performed to provoke EIA. Before and after the challenge test pulmonary function variables (e.g. forced expiratory volume in one second (FEV1)) will be measured in order to assess the protective effect of the study medication.

Details

Lead sponsor	MEDA Pharma GmbH & Co. KG
Phase	Phase 2
Status	COMPLETED
Enrolment	62
Start date	2007-11
Completion	2008-10

Conditions

• Asthma, Exercise-Induced

Interventions

• Combination DSCG and Reproterol

Primary outcomes

• Primary objective: to demonstrate superiority of the protective effect of the fixed combination of disodium cromoglycate (DSCG) plus reproterol in comparison to the single component reproterol in adults suffering from exercise induced asthma (EIA). — 5, 10, 15, 30 and 60 minutes after drug application

Countries

Germany