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 - AERIA

• Conditions: MedDRA version: 9.1Level: LLTClassification code 10015649Term: Exercise induced asthma; Exercise induced asthma

• Registration Number: EUCTR2007-002553-23-DE
• Lead Sponsor: MEDA Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-06
• Last Update Posted: 3 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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. < 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, tubal ligation or vasectomised partner.
3. Subjects with an asthma exacerbation within 4 weeks prior to the study start. Asthma exacerbation defined as use of oral (systemic) glucocorticosteroids, unscheduled consultation of a medic due to asthma, hospitalisation, or additional treatment of asthma with antibiotics
4. Eosinophilic pneumonia
5. Clinically significant cardiovascular diseases (e.g. cardiac infarction, cardiac dysrhythmia, hypertrophic obstructive cardiomyopathy, coronary heart disease...)
6. Resting blood pressure over 140/90 mmHg
7. Diastolic blood pressure after treadmill-test over 120 mmHg
8. Malignancies including phaeochromocytoma within the last 5 years
9. Severe hyperthyreosis, thyreotoxicosis, instable diabetes mellitus
Lack of suitability for the trial:
10. Subjects with seasonal asthma during their asthma season
11. Infectious disease of the upper airways within 2 weeks prior to the study and within 4 weeks prior to study in case of use of antibiotics
12. Relevant respiratory disorder other than asthma
13. Clinically significant renal, endocrine, haematological, hepatic, immunological, gastrointestinal, neurological, or psychiatric diseases
14. Any chronic disease which might influence absorption, metabolism, or excretion of the trial substances
15. Change of inhalative glucocorticosteroid dosage and / or antiasthmatic controller therapy within the last 4 weeks prior to or during the study
16. Concomitant systemic treatment with glucocorticosteroids
17. Concomitant treatment with any ß-antagonistic drug
18. Need of rescue medication within 15 min after challenge
19. Concomitant therapy with antidepressants or neuroleptics
20. Drug or alcohol abuse which would interfere with the subjects proper completion of the protocol assignment and mentally handicapped subjects
21. Smokers within the last 6 months or smoking history > 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)