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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT No.: 2007-002553-23 |
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| Name | Class |
|---|---|
| ClinResearch, GmbH | OTHER |
| Sanofi | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | DSCG + Reproterol |
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| 2 | Active Comparator | DSCG |
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| 3 | Active Comparator | Reproterol |
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| 4 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination DSCG and Reproterol | Drug | 1: |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5, 10, 15, 30 and 60 minutes after drug application |
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Inclusion Criteria:
Exclusion Criteria:
Safety concerns:
Lack of suitability for the trial:
Administrative reasons:
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| Name | Affiliation | Role |
|---|---|---|
| Roland Buhl, MD, Prof. | Clinical Research Pneumology, III. Medical Clinic, University Clinic Mainz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kurmittelhaus der Moderne | Bad Reichenhall | D-83435 | Germany | |||
| Asthma Center Buchenhoehe |
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| ID | Term |
|---|---|
| D001250 | Asthma, Exercise-Induced |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| C014792 | reproterol |
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| Berchtesgaden |
| D-83471 |
| Germany |
| Practice Dr. T. Ginko | Bonn | D-53119 | Germany |
| Clinic St. Georg Leipzig, Robert Koch Clinic | Leipzig | D-04207 | Germany |
| Clinical Research Pneumology, III. Medical Clinic, University Clinic Mainz | Mainz | D-55131 | Germany |
| Practice Dr. W. Schürmann | Marburg | D-35037 | Germany |
| Institute for Pulmonary Research GmbH | Wiesbaden | D-65187 | Germany |
| D000092202 |
| Exercise-Induced Allergies |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |