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.
* 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
62
Kurmittelhaus der Moderne
Bad Reichenhall, Germany
Asthma Center Buchenhoehe
Berchtesgaden, Germany
Practice Dr. T. Ginko
Bonn, Germany
Clinic St. Georg Leipzig, Robert Koch Clinic
Leipzig, Germany
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
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
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Clinical Research Pneumology, III. Medical Clinic, University Clinic Mainz
Mainz, Germany
Practice Dr. W. Schürmann
Marburg, Germany
Institute for Pulmonary Research GmbH
Wiesbaden, Germany