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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-13

Study Completion Date

2020-12-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Clinical Trial to Test a Study Drug in Volunteers Who Develop Asthma Following Exercise

NCT00812929

Asthma

COMPLETED PHASE2

Asthma Control: Increased Physical Activity in Young Adults

NCT04944199

Asthma in Young Adults

COMPLETED NA

A Phase 2A Study to Evaluate the Safety and Effect on Exercise Challenge Testing of MEDI-528 in Adults With Asthma

NCT00590720

Asthma

TERMINATED PHASE2

Effect of Aerobic Training in Moderate or Severe Asthmatic Patients

NCT02033122

Asthma.

UNKNOWN PHASE3

Targeted Small Airways Therapy in Persistent Asthma

NCT01894048

Asthma

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A randomized, controlled parallel group, outcome assessor blinded, clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Single blindet, randomization and training intervention by non-investigator. Open-label after primary follow up. After unblinding, blindet 3rd party performs tests (visit 9 and 12 months, e.g. spirometry)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Training group

Supervised High intensity interval training (HIIT) 3 times a week for 6 months.

Training session:

10 minutes warm up (Low-moderate intensity) 30 minutes intervention (16 minutes HIIT) 10 minutes cool down(Low-moderate intensity)

Group Type ACTIVE_COMPARATOR

High Intensity Interval Training

Intervention Type BEHAVIORAL

Training (HIIT)

Control group

Control group, usual lifestyle. Aside from training intervention, all other visits are the same as intervention group (training).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High Intensity Interval Training

Training (HIIT)

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Training group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No