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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

  • 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.

    • Sponsor: MEDA Pharma GmbH & Co. KG

    Current Primary Outcome: 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). [ Time Frame: 5, 10, 15, 30 and 60 minutes after drug application ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome: 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. [ Time Frame: 5, 10, 15, 30 and 60 minutes after drug application ]

    Original Secondary Outcome: Same as current

    Information By: MEDA Pharma GmbH & Co. KG

    Dates:
    Date Received: October 21, 2008
    Date Started: November 2007
    Date Completion:
    Last Updated: April 7, 2009
    Last Verified: April 2009