Status:
COMPLETED
The Effect of Physical Exercise in a Cold Air Environment on Normal Volunteers and Asthmatic Patients
Lead Sponsor:
KU Leuven
Conditions:
Asthma, Exercise-Induced
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The purpose of the study is to compare airway physiologic reactions to physical exercise in a cold air environment (-5°C, 60% relative humidity) between normal volunteers and subjects with mild/modera...
Detailed Description
It is already demonstrated that exercising during cold air exposure and at a high altitude may induce asthmatic symptoms, a variable degree of airway obstruction and increased neutrophilic airway infl...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA - healthy volunteers
- age between 18 and 60 years at time of signing informed consent
- BMI between 18-28 kg/m2
- able to comply with study protocol, in the investigator's judgement
- non-smoking or ex-smokers for at least 12 months with less than 10 pack years
- no immunoglobulin E (IgE) mediated hypersensitivity
- normal spirometry \& normal ECG at screening
- negative histamine provocation (defined as His- if PC20 \>/= 8 mg/ml and His+ healthy controls if PC20 \> 4 mg/ml and \< 8 mg/ml)
- INCLUSION CRITERIA - asthmatic patients
- age between 18 and 60 years at time of signing informed consent
- BMI between 18-28 kg/m2
- able to comply with study protocol, in the investigator's judgement
- non-smoking or ex-smokers for at least 12 months with less than 10 pack years
- physician-diagnosed asthma for more than 6 months
- post bronchodilator FEV1 of ≥ 80% at screening
- documented airway reversibility either by means of post bronchodilator reversibility of \> 12% and \> 200 ml or in the previous 6 months or by means of documented airway hyperresponsiveness (histamine PC20 \<8 mg/ml) at screening
- Asthma Control Questionnaire (ACQ) \< 1,5
- regular treatment with inhaled corticosteroids (ICS) with or without long-acting beta-agonists (LABA) (unchanged dose for at least 1 month)
- normal ECG at screening
- EXCLUSION CRITERIA - healthy volunteers
- physician-diagnosed asthma or history of (post)infectious bronchial hyperreactivity
- major pulmonary or cardiovascular disease
- treatment with β-blockers
- pregnancy
- EXCLUSION CRITERIA - asthmatics patients
- unable to produce sputum with sputum induction
- previous history of intubation or admission to the intensive care unit due to asthma
- severe asthma exacerbation within one year prior to screening visit
- treatment with oral or systemic steroids within one year prior to screening visit
- previous treatment with biologics for asthma
- treatment with β-blockers
- other major concurrent pulmonary (such as chronic obstructive pulmonary disease, cystic fibrosis, sarcoidosis, interstitial lung disease, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, bronchiectasis) or cardiovascular disease
- pregnancy
Exclusion
Key Trial Info
Start Date :
June 3 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03840044
Start Date
June 3 2019
End Date
May 30 2020
Last Update
December 17 2020
Active Locations (1)
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1
UZ Leuven Gasthuisberg
Leuven, Belgium, 3000