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

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ClinicalTrials.gov Identifier: NCT03290898
Recruitment Status : Completed
First Posted : September 25, 2017
Last Update Posted : March 15, 2021
Sponsor:
Information provided by (Responsible Party):
Vibeke Backer, Bispebjerg Hospital

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.

Condition or disease Intervention/treatment Phase
Asthma Behavioral: High Intensity Interval Training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, controlled parallel group, outcome assessor blinded, clinical trial
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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)
Primary Purpose: Treatment
Official Title: REPLACE: Can Exercise Replace Inhaled Corticosteroid Treatment in Asthma? A Randomized Clinical Trial
Actual Study Start Date : October 13, 2017
Actual Primary Completion Date : June 26, 2020
Actual Study Completion Date : December 4, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Training (HIIT)
Other Name: Training group

No Intervention: Control group
Control group, usual lifestyle. Aside from training intervention, all other visits are the same as intervention group (training).



Primary Outcome Measures :
  1. Reduced inhaled corticosteroid (ICS) 6 months [ Time Frame: 6 months +/- 7 days ]
    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


Secondary Outcome Measures :
  1. Reduced inhaled corticosteroid (ICS) 12 months [ Time Frame: 12 months +/- 7 days ]
    The proportion of participants at 12 months that have been down-titrated in ICS dose by at least 25 % compared to baseline.

  2. Cumulated ICS 6 months [ Time Frame: 6 months +/- 7 days ]
    Change from baseline in cumulated dose of ICS at 6 months

  3. Cumulated ICS 12 months [ Time Frame: 12 months +/- 7 days ]
    Change from baseline in cumulated dose of ICS at 12 months

  4. Cumulated Long acting beta2 agonists (LABA) 6 months [ Time Frame: 6 months +/- 7 days ]
    Change from baseline in cumulated dose of LABA at 6 months

  5. Cumulated LABA 12 months [ Time Frame: 12 months +/- 7 days ]
    Change from baseline in cumulated dose of LABA at 12 months

  6. Exacerbation rate 6 months [ Time Frame: 6 months +/- 7 days ]
    Number of exacerbations (moderate-severe) at 6 months

  7. Exacerbation rate 12 months [ Time Frame: 12 months +/- 7 days ]
    Number of exacerbations (moderate-severe) at 12 months

  8. miniAQLQ 6 months [ Time Frame: 6 months +/- 7 days ]
    Change from baseline in Asthma life quality evaluated by miniAQLQ at 6 months

  9. miniAQLQ 12 months [ Time Frame: 12 months +/- 7 days ]
    Change from baseline in Asthma life quality evaluated by miniAQLQ at 12 months

  10. Fraction of exhaled Nitrogen Oxid 6 months [ Time Frame: 6 months +/- 7 days ]
    Change from baseline in Airway inflammation evaluated by FeNO at 6 months

  11. Fraction of exhaled Nitrogen Oxid 12 months [ Time Frame: 12 months +/- 7 days ]
    Change from baseline in Airway inflammation evaluated by FeNO at 12 months

  12. Sputum cell count 6 months [ Time Frame: 6 months +/- 7 days ]
    Change from baseline in Airway inflammation evaluated by sputum cell count at 6 months

  13. Sputum cell count 12 months [ Time Frame: 12 months +/- 7 days ]
    Change from baseline in Airway inflammation evaluated by sputum cell count at 12 months

  14. Systemic inflammation 6 months [ Time Frame: 6 months +/- 7 days ]
    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

  15. Systemic inflammation 12 months [ Time Frame: 12 months +/- 7 days ]
    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

  16. Airway hyperresponsiveness [ Time Frame: 6 months +/- 7 days ]
    Change from baseline in airway hyperresponsiveness measured by methacholine test at 6 months

  17. FEV1 6 months [ Time Frame: 6 months +/- 7 days ]
    Change from baseline in lung function evaluated by FEV1 at 6 months

  18. FVC 6 months [ Time Frame: 6 months +/- 7 days ]
    Change from baseline in lung function evaluated by FVC at 6 months

  19. FEV1 12 months [ Time Frame: 12 months +/- 7 days ]
    Change from baseline in lung function evaluated by FEV1 at 12 months

  20. FVC 12 months [ Time Frame: 12 months +/- 7 days ]
    Change from baseline in lung function evaluated by FVC at 12 months

  21. Cardiopulmonary fitness [ Time Frame: 6 months +/- 7 days ]
    Change from baseline in cardiopulmonary fitness evaluated by maximum oxygen consumption at 6 months (VO2max)

  22. Change in fat and muscle composition (DEXA scan) [ Time Frame: 6 months +/- 7 days ]
    Change from baseline in fat and muscle composition evaluated by DEXA scan


Other Outcome Measures:
  1. Eosinophilic subpopulation - exploratory analyses 6 months [ Time Frame: 6 months +/- 7 days ]
    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.

  2. Eosinophilic subpopulation - exploratory analyses 12 months [ Time Frame: 12 months +/- 7 days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290898


Locations
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Denmark
Respiratory Research Unit, Birpebjerg Hospital
Copenhagen NV, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
Investigators
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Principal Investigator: Vibeke Backer, professor Rigshospitalet, Denmark
  Study Documents (Full-Text)

Documents provided by Vibeke Backer, Bispebjerg Hospital:
Study Protocol  [PDF] October 2, 2017
Statistical Analysis Plan  [PDF] December 22, 2020

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Responsible Party: Vibeke Backer, Professor dr.med., Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT03290898    
Other Study ID Numbers: REPLACE
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vibeke Backer, Bispebjerg Hospital:
Asthma
Exercise
Asthma treatment
Inhaled corticosteroid
Rehabilitation
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases