Status:
COMPLETED
To Assess the Protective Effect of the Fixed Drug Combination of Disodium Cromoglycate Plus Reproterol
Lead Sponsor:
MEDA Pharma GmbH & Co. KG
Collaborating Sponsors:
ClinResearch, GmbH
Sanofi
Conditions:
Asthma, Exercise-Induced
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 ch...
Detailed Description
* 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 ad...
Eligibility Criteria
Inclusion
- Female and male subjects aged 18 - 65 years
- 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)
- Baseline FEV1 before challenge must be \> or = 70% of the predicted FEV1
Exclusion
- Safety concerns:
- Subjects with hypersensitivity to DSCG, reproterol, menthol, peppermint or other excipients of the study medication
- 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 result 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
- 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
- Eosinophilic pneumonia
- Clinically significant cardiovascular diseases (e.g. cardiac infarction, cardiac dysrhythmia, hypertrophic obstructive cardiomyopathy, coronary heart disease…)
- Resting blood pressure over 140/90 mmHg
- Diastolic blood pressure after treadmill-test over 120 mmHg
- Malignancies including phaeochromocytoma within the last 5 years
- Severe hyperthyreosis, thyreotoxicosis, instable diabetes mellitus
- Lack of suitability for the trial:
- Subjects with seasonal asthma during their asthma season
- 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
- Relevant respiratory disorder other than asthma
- Clinically significant renal, endocrine, haematological, hepatic, immunological, gastrointestinal, neurological, or psychiatric diseases
- Any chronic disease which might influence absorption, metabolism, or excretion of the trial substances
- Change of inhalative glucocorticosteroid dosage and / or antiasthmatic controller therapy within the last 4 weeks prior to or during the study
- Concomitant systemic treatment with glucocorticosteroids
- Concomitant treatment with any ß-antagonistic drug
- Need of rescue medication within 15 min after challenge
- Concomitant therapy with antidepressants or neuroleptics
- Drug or alcohol abuse which would interfere with the subjects proper completion of the protocol assignment and mentally handicapped subjects
- 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)
- Exposure to another investigational agent within the last 4 weeks prior to this one or during this study
- Non-cooperative subjects not able to understand the instructions for use of the devices
- Administrative reasons:
- Lack of ability or willingness to give informed consent
- Lack of willingness to have personal study related data collected, archived or transmitted according to protocol
- Anticipated non-availability for study visits / procedures
- Personnel involved in the planning or conduct of the study
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00777348
Start Date
November 1 2007
End Date
October 1 2008
Last Update
February 7 2022
Active Locations (7)
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1
Kurmittelhaus der Moderne
Bad Reichenhall, Germany, D-83435
2
Asthma Center Buchenhoehe
Berchtesgaden, Germany, D-83471
3
Practice Dr. T. Ginko
Bonn, Germany, D-53119
4
Clinic St. Georg Leipzig, Robert Koch Clinic
Leipzig, Germany, D-04207