NCT00777348

To Assess the Protective Effect of the Fixed Drug Combination of Disodium Cromoglycate Plus Reproterol

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: MEDA Pharma GmbH & Co. KG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

* 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). * Secondary objectives: to demonstrate superiority of the protective effect of DSCG plus reproterol in comparison to the single component DSCG; to demonstrate superiority of the protective effect of each single component in comparison to placebo. In addition, the tolerability of medications will be documented.

Conditions

• Asthma, Exercise-Induced

Interventions

Type	Name	Description
DRUG	Combination DSCG and Reproterol	1:

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-10-22
• Last updated: 2022-02-07

Locations

7 sites across 1 country: Germany