To Assess the Protective Effect of the Fixed Drug Combination of Disodium Cromoglycate Plus Reproterol (AERIA)

This is an interventional treatment trial for Asthma, Exercise-Induced Read More

Inclusion Criteria:

• 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 Criteria:

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