Clinical trial NCT03290898: REPLACE: Can Exercise Replace Inhaled Corticosteroid Treatment in Asthma? A RCT
Official title: REPLACE: Can Exercise Replace Inhaled Corticosteroid Treatment in Asthma? A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Exercise
Asthma treatment
Inhaled corticosteroid
Rehabilitation
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, controlled parallel group, outcome assessor blinded, clinical trial
Primary purpose: TREATMENT

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 asthmatics.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reduced inhaled corticosteroid (ICS) 6 months
timeFrame: 6 months +/- 7 days
Secondary outcomes:
measure: Reduced inhaled corticosteroid (ICS) 12 months
timeFrame: 12 months +/- 7 days
measure: Cumulated ICS 6 months
timeFrame: 6 months +/- 7 days
measure: Cumulated ICS 12 months
timeFrame: 12 months +/- 7 days
measure: Cumulated Long acting beta2 agonists (LABA) 6 months
timeFrame: 6 months +/- 7 days
measure: Cumulated LABA 12 months
timeFrame: 12 months +/- 7 days
measure: Exacerbation rate 6 months
timeFrame: 6 months +/- 7 days
measure: Exacerbation rate 12 months
timeFrame: 12 months +/- 7 days
measure: miniAQLQ 6 months
timeFrame: 6 months +/- 7 days
measure: miniAQLQ 12 months
timeFrame: 12 months +/- 7 days
measure: Fraction of exhaled Nitrogen Oxid 6 months
timeFrame: 6 months +/- 7 days
measure: Fraction of exhaled Nitrogen Oxid 12 months
timeFrame: 12 months +/- 7 days
measure: Sputum cell count 6 months
timeFrame: 6 months +/- 7 days
measure: Sputum cell count 12 months
timeFrame: 12 months +/- 7 days
measure: Systemic inflammation 6 months
timeFrame: 6 months +/- 7 days
measure: Systemic inflammation 12 months
timeFrame: 12 months +/- 7 days
measure: Airway hyperresponsiveness
timeFrame: 6 months +/- 7 days
measure: FEV1 6 months
timeFrame: 6 months +/- 7 days
measure: FVC 6 months
timeFrame: 6 months +/- 7 days
measure: FEV1 12 months
timeFrame: 12 months +/- 7 days
measure: FVC 12 months
timeFrame: 12 months +/- 7 days
measure: Cardiopulmonary fitness
timeFrame: 6 months +/- 7 days
measure: Change in fat and muscle composition (DEXA scan)
timeFrame: 6 months +/- 7 days
Other outcomes:
measure: Eosinophilic subpopulation - exploratory analyses 6 months
timeFrame: 6 months +/- 7 days
measure: Eosinophilic subpopulation - exploratory analyses 12 months
timeFrame: 12 months +/- 7 days
Locations:
city: Copenhagen NV
country: Denmark
facility: Respiratory Research Unit, Birpebjerg Hospital
Study officials:
affiliation: Rigshospitalet, Denmark
name: Vibeke Backer, professor
role: PRINCIPAL_INVESTIGATOR
References: