The Effect of Physical Exercise in a Cold Air Environment on Normal Volunteers and Asthmatic Patients (ALASCAIR1)
Asthma, Exercise-Induced
About this trial
This is an interventional basic science trial for Asthma, Exercise-Induced focused on measuring Asthma, Exercise, Cold air exposure
Eligibility Criteria
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
Sites / Locations
- UZ Leuven Gasthuisberg
Arms of the Study
Arm 1
Arm 2
Other
Other
Healthy volunteers
Asthmatic subjects
Healthy volunteers will perform the same protocol as foreseen for asthmatic patients. Both will perform the cold air exercise test with pre -and post-exposure evaluation of on FEV1, respiratory symptoms, functional airway integrity, local and systemic inflammation and on the airway microbiome.
Asthmatic patients will perform the same protocol as foreseen for healthy volunteers. They will perform the cold air exercise test with pre -and post-exposure evaluation of on FEV1, respiratory symptoms, functional airway integrity, local and systemic inflammation and on the airway microbiome.