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

Bispebjerg Hospital150 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Asthma

Interventions

High Intensity Interval TrainingBEHAVIORAL

Training (HIIT)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Respiratory Research Unit, Birpebjerg Hospital

Copenhagen NV, Denmark

Outcomes

Primary Outcomes

Reduced inhaled corticosteroid (ICS) 6 months

The proportion of participants at 6 months that have been down-titrated in ICS dose by at least 25% compared to the participants' baseline dose

Time frame: 6 months +/- 7 days

Secondary Outcomes

Reduced inhaled corticosteroid (ICS) 12 months

The proportion of participants at 12 months that have been down-titrated in ICS dose by at least 25 % compared to baseline.

Time frame: 12 months +/- 7 days

Cumulated ICS 6 months

Change from baseline in cumulated dose of ICS at 6 months

Time frame: 6 months +/- 7 days

Cumulated ICS 12 months

Change from baseline in cumulated dose of ICS at 12 months

Time frame: 12 months +/- 7 days

Cumulated Long acting beta2 agonists (LABA) 6 months

Change from baseline in cumulated dose of LABA at 6 months

Time frame: 6 months +/- 7 days

Cumulated LABA 12 months

Change from baseline in cumulated dose of LABA at 12 months

Time frame: 12 months +/- 7 days

Exacerbation rate 6 months

Number of exacerbations (moderate-severe) at 6 months

Time frame: 6 months +/- 7 days

Exacerbation rate 12 months

Number of exacerbations (moderate-severe) at 12 months

Data from ClinicalTrials.gov

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