REPLACE: Can Exercise Replace Inhaled Corticosteroid Treatment in Asthma? A RCT

At least 102 asthmatics will be randomized 2:1 (2 to training group; 1 to control) and undergo 6 months of intervention or usual lifestyle.

Subjects must have confirmed asthma diagnosis, on a stable treatment with inhaled corticosteroid, symptomatic and untrained.

At enrollment and during the study asthma medicine is adjusted based on asthma symptoms evaluated by ACQ-5. 6 treatment steps are pre-defined, and if well controlled asthma, subjects are down-titrated one step, if uncontrolled, subjects are uptitrated one step.

Inclusion criteria

• Asthma (The diagnose of asthma is based on symptoms and at least one positive asthma test the last 5 years (AHR to either mannitol or methacholine, reversibility to beta2-agonist, peak flow variation or positive eucapnic voluntary hyperventilation test))
• ACQ ≥ 1 and ≤ 2.5
• On a daily dose of ICS at a minimum of 400 µg budesonide or equivalent ICS for 3 months and with no changes in asthma medicine 4 weeks prior to enrollment
• Untrained (no participation in vigorous exercise for more than 1 hour per week during the last 2 month)
• Capable of exercising on bike

Exclusion criteria

• Unable to speak and understand Danish
• Infection within 4 weeks prior to visit 100*
• Asthma exacerbation within 4 weeks prior to visit 100*
• Hospitalized for an asthma attack during the last 2 months
• Treatment with immunotherapy within 5 T½ of the treatment drug prior to visit 100
• Initiation of allergen immunotherapy within 3 months prior to visit 100 or plan to begin therapy during study period
• Treatment with peroral prednisolone
• Respiratory: other chronic pulmonary disease of clinically significance
• Cardiovascular: Unstable ischemic heart disease, myocardial infarction within the last 12 months, symptomatic heart failure (NYHA III-IV or EF <40%), symptomatic heart arrhythmia (documented with ECG), uncontrolled hypertension (>155/100)
• Pregnancy or breastfeeding or planned pregnancy within the next 12 months
• Other inflammatory or metabolic diseases with the exception of rhinitis, atopy and well-controlled hypothyroidism treated with or without Eltroxin
• Vaccination less than 2 weeks prior to any visit
• Current or former smokers with > 20 pack years
• Subjects, who by investigators determination, will not be able to adhere to study protocol

• If patients are excluded due to a recent infection or exacerbation they can undergo re-screening after a total of 4 weeks after end of exacerbation treatment/clearing the infection.