ClinicalTrials.gg
CompletedNCT03290898Updated Mar 15, 2021

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

An interventional study of High Intensity Interval Training in Asthma, sponsored by Bispebjerg Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-03-15.

Sponsored by Bispebjerg Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 19 studies in Asthma by Bispebjerg Hospital — none open to participants now, none under way, none of them phase 3. Asthma · Bispebjerg Hospital.

Enrollment
Largest of 11
150 · median 39
Started
2017
with 1 other
No phase
4 of 19
none open now
Registered
14th of 19
by date

Among the 19 studies in Asthma by Bispebjerg Hospital, this one has the largest enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2017, is one of 4 with no phase, and was the 14th registered.

Asthma

4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.

Browse Asthma studies →

Open to participants now

None of the 19 studies in Asthma by Bispebjerg Hospital is open now.

Where they have run

Who these studies take

Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 146 take children under 18; 104 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Download CSVNarrow it in search →With an account: the 19 studies in Asthma by Bispebjerg Hospital as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Asthma

Keywords

  • Asthma
  • Exercise
  • Asthma treatment
  • Inhaled corticosteroid
  • Rehabilitation
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 ( III-IV or EF \<40%), symptomatic heart arrhythmia (documented with ), 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
150 participants (actual)

Study arms

  • Active comparator
    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)

    Behavioral: High Intensity Interval Training

  • No intervention
    Control group

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

Interventions

  • BehavioralHigh Intensity Interval Training

    Training (HIIT)

    Also known as: Training group

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. Cumulated ICS 6 months

    Change from baseline in cumulated dose of ICS at 6 months

    Time frame: 6 months +/- 7 days

  3. Cumulated ICS 12 months

    Change from baseline in cumulated dose of ICS at 12 months

    Time frame: 12 months +/- 7 days

  4. 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

  5. Cumulated LABA 12 months

    Change from baseline in cumulated dose of LABA at 12 months

    Time frame: 12 months +/- 7 days

  6. Exacerbation rate 6 months

    Number of exacerbations (moderate-severe) at 6 months

    Time frame: 6 months +/- 7 days

  7. Exacerbation rate 12 months

    Number of exacerbations (moderate-severe) at 12 months

    Time frame: 12 months +/- 7 days

  8. miniAQLQ 6 months

    Change from baseline in Asthma life quality evaluated by miniAQLQ at 6 months

    Time frame: 6 months +/- 7 days

  9. miniAQLQ 12 months

    Change from baseline in Asthma life quality evaluated by miniAQLQ at 12 months

    Time frame: 12 months +/- 7 days

  10. Fraction of exhaled Nitrogen Oxid 6 months

    Change from baseline in Airway inflammation evaluated by FeNO at 6 months

    Time frame: 6 months +/- 7 days

  11. Fraction of exhaled Nitrogen Oxid 12 months

    Change from baseline in Airway inflammation evaluated by FeNO at 12 months

    Time frame: 12 months +/- 7 days

  12. Sputum cell count 6 months

    Change from baseline in Airway inflammation evaluated by sputum cell count at 6 months

    Time frame: 6 months +/- 7 days

  13. Sputum cell count 12 months

    Change from baseline in Airway inflammation evaluated by sputum cell count at 12 months

    Time frame: 12 months +/- 7 days

  14. Systemic inflammation 6 months

    Change from baseline in systemic inflammation evaluated by blood eosinophilic, hsCRP and inflammatory cytokines (e.g. IL-6 and IL-8) and TNF-alfa at 6 months

    Time frame: 6 months +/- 7 days

  15. Systemic inflammation 12 months

    Change from baseline in systemic inflammation evaluated by blood eosinophilic, hsCRP and inflammatory cytokines (e.g. IL-6 and IL-8) and TNF-alfa at 12 months

    Time frame: 12 months +/- 7 days

  16. Airway hyperresponsiveness

    Change from baseline in airway hyperresponsiveness measured by methacholine test at 6 months

    Time frame: 6 months +/- 7 days

  17. FEV1 6 months

    Change from baseline in lung function evaluated by FEV1 at 6 months

    Time frame: 6 months +/- 7 days

  18. FVC 6 months

    Change from baseline in lung function evaluated by FVC at 6 months

    Time frame: 6 months +/- 7 days

  19. FEV1 12 months

    Change from baseline in lung function evaluated by FEV1 at 12 months

    Time frame: 12 months +/- 7 days

  20. FVC 12 months

    Change from baseline in lung function evaluated by FVC at 12 months

    Time frame: 12 months +/- 7 days

  21. Cardiopulmonary fitness

    Change from baseline in cardiopulmonary fitness evaluated by maximum oxygen consumption at 6 months (VO2max)

    Time frame: 6 months +/- 7 days

  22. Change in fat and muscle composition (DEXA scan)

    Change from baseline in fat and muscle composition evaluated by DEXA scan

    Time frame: 6 months +/- 7 days

Other outcomes

  1. Eosinophilic subpopulation - exploratory analyses 6 months

    To evaluate the effect of the intervention in sub-populations of asthmatics using different cut-off values of blood eosinophilics. Both regarding primary outcome and secondary outcomes.

    Time frame: 6 months +/- 7 days

  2. Eosinophilic subpopulation - exploratory analyses 12 months

    To evaluate the effect of the intervention in sub-populations of asthmatics using different cut-off values of blood eosinophilics with regards to secondary outcomes at 12 months.

    Time frame: 12 months +/- 7 days

07

Study locations

1 site
  • Respiratory Research Unit, Birpebjerg Hospital
    Copenhagen NV, 2400, Denmark
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Jun 2020, 32 months.

Of 599 non-industry interventional studies with no phase under Asthma, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's 32 months is above that.

Counting every sponsor, half of 649 studies reached it within 23 months; a quarter within 10 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2017
First posted
Sep 25, 2017
StartActual
Oct 13, 2017
Primary completionActual
Jun 26, 2020
CompletionActual
Dec 4, 2020
Last update
Mar 15, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03290898
Responsible party
Vibeke Backer (Professor dr.med., Bispebjerg Hospital) — Principal investigator
First posted
Sep 25, 2017
Start date
Oct 13, 2017
Primary completion
Jun 26, 2020
Completion
Dec 4, 2020
Last update
Mar 15, 2021

Study contacts

Vibeke Backer, professor
principal investigator · Rigshospitalet, Denmark

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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