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COMPLETEDNA

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

REPLACE: Can Exercise Replace Inhaled Corticosteroid Treatment in Asthma? A Randomized Clinical Trial

NCT03290898•Bispebjerg Hospital

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Locations (1)

Respiratory Research Unit, Birpebjerg Hospital

Copenhagen NV, Denmark

Key Dates

Start Date

October 13, 2017

Primary Completion Date

June 26, 2020

Completion Date

December 4, 2020

Last Updated

March 15, 2021

Enrollment

150

ACTUAL participants

Conditions

Asthma

Interventions

High Intensity Interval Training

BEHAVIORAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 15, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma