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

Asthma, Exercise-Induced Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00777348
Study type	Interventional
Source	Viatris Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	November 2007
Completion date	October 2008

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