Exercise induced asthma MedDRA version: 9.1 Level: LLT Classification code 10015649 Term: Exercise induced asthma
Conditions
Interventions
Trade Name: Allergospasmin N
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: Cromoglycate
CAS Number: 15826-37-6
Other descriptive name: Disodium Cromoglycate
Concentratio
Sponsors
MEDA Pharma GmbH & Co. KG
MEDA Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Female and male subjects aged 18 – 65 years 2. Exercise induced asthma with reversible airway obstruction: twice proven EIA defined as maximum decrease in FEV1 against the baseline value of at least 20% (first test results can be obtained during the last 12 months) 3. Baseline FEV1 before challenge must be at least 70% of the predicted FEV1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Safety concerns: 1. Subjects with hypersensitivity to DSCG, reproterol, menthol, peppermint or other excipients of the study medication 2. Pregnancy, breast-feeding or planned pregnancy during the study. Women of child bearing potential not using a highly effective method of birth control defined as those which results in a low failure rate (i.e. 10 pack-years (a pack-year is 20 cigarettes per day for one year or equivalent) 22. Exposure to another investigational agent within the last 4 weeks prior to this one or during this study 23. Non-cooperative subjects not able to understand the instructions for use of the devices Administrative reasons: 24. Lack of ability or willingness to give informed consent 25. Lack of willingness to have personal study related data collected, archived or transmitted according to protocol 26. Anticipated non-availability for study visits / procedures 27. Personnel involved in the planning or conduct of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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 Objective: 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.;Primary end point(s): Confirmatory: maximum percentage decrease in FEV1 from baseline (t=-5 for fixed combination vs. reproterol and t=-25 for other comparisons) | — |
Countries
Germany
Outcome results
None listed