Status:
COMPLETED
REPLACE: Can Exercise Replace Inhaled Corticosteroid Treatment in Asthma? A RCT
Lead Sponsor:
Bispebjerg Hospital
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
To evaluate if physical exercise intervention leads to an improved asthma control as measured by Asthma Control Questionnaire (ACQ-5) in such a magnitude that inhaled corticosteroid can be reduces in ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2020
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03290898
Start Date
October 13 2017
End Date
December 4 2020
Last Update
March 15 2021
Active Locations (1)
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1
Respiratory Research Unit, Birpebjerg Hospital
Copenhagen NV, Denmark, 2400