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Pulmonary Rehabilitation for Uncontrolled Asthma Associated With Elevated BMI (PRODA01)

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ClinicalTrials.gov Identifier: NCT03630432
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Brief Summary:

Aim to evaluate the impact of a pulmonary rehabilitation (rehab) programme tailored and delivered to overweight and obese patients with difficult asthma on:

  1. Asthma related quality of life (primary outcome) and asthma control (secondary outcome)
  2. Treatment burden and healthcare usage (secondary outcomes)
  3. Physical activity level, exercise tolerance, lung function and inflammation (secondary outcome)
  4. Anxiety and depression (secondary outcome)

Condition or disease Intervention/treatment Phase
Asthma Behavioral: Pulmonary rehabilitation Other: Usual Care Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised, parallel, controlled study of 8 weeks pulmonary rehabilitation versus usual care
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pragmatic, Randomised, Controlled, Trial of the Effect of a Tailored Pulmonary Rehabilitation Package in Uncontrolled Asthma Associated With Elevated Body Mass Index
Actual Study Start Date : May 11, 2017
Estimated Primary Completion Date : May 10, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group A
Immediate 8 week course of pulmonary rehabilitation
Behavioral: Pulmonary rehabilitation

The pulmonary rehabilitation course will be provided on a rolling basis and for each individual will be of 8 weeks duration including once weekly, 1.5 hour hospital sessions and encouragement to perform twice weekly home exercise sessions. Hospital sessions will include 1 hour of supervised exercise and 30 minutes education.

Exercise Component: This will include a combination of aerobic, resistance and flexibility training.

Educational Component will cover many topics including what is asthma, treatments and inhaler technique, self-management, importance of exercise and health promotion.

On completion of the formal pulmonary rehabilitation course, participants will be encouraged to continue regular exercise sessions by accessing community based "Vitality Classes".


Placebo Comparator: Group B
Initial 8 weeks of usual care
Other: Usual Care
Usual Care




Primary Outcome Measures :
  1. AQLQ- Asthma quality of life questionnaire [ Time Frame: 8 weeks ]
    change from week 0 to week 8 for pulmonary rehab vs usual care control group. AQLQ consists of 32 questions related to quality of life scored out of 7, and then averaged. Total score is out of 7 with 1 being the worst and 7 the best. There is also a score between 1 and 7 for 4 subscales which cover areas of symptoms, activity limitation, emotional function and environmental stimuli. These subscales are also averaged over a number of questions with 1 being worst and 7 best.


Secondary Outcome Measures :
  1. AQLQ- asthma quality of life questionnaire [ Time Frame: 8 weeks ]
    percentage with more than or equal to 0.5 point improvement from beginning to end of pulmonary rehab programme versus percentage in usual care control group. AQLQ consists of 32 questions related to quality of life scored out of 7, and then averaged. Total score is out of 7 with 1 being the worst and 7 the best. There is also a score between 1 and 7 for 4 subscales which cover areas of symptoms, activity limitation, emotional function and environmental stimuli. These subscales are also averaged over a number of questions with 1 being worst and 7 best.

  2. ACQ6- asthma control questionnaire 6 [ Time Frame: 8 weeks ]
    Change from week 0 to week 8 for pulmonary rehab vs usual care control group. ACQ6 comprises 6 questions scored out of 6 then averaged, value will range from 0-6, with 0 reflecting excellent asthma control and 6 very poor control.

  3. ACQ6- asthma control questionnaire 6 [ Time Frame: 8 weeks ]
    percentage with more than or equal to 0.5 point improvement from beginning to end of pulmonary rehab programme versus percentage in usual care control group. ACQ6 comprises 6 questions scored out of 6 then averaged, value will range from 0-6, with 0 reflecting excellent asthma control and 6 very poor control.

  4. ACQ6- asthma control questionnaire 6 [ Time Frame: 48 (or 56) weeks depending on group ]
    Change from baseline to end of study period. ACQ6 comprises 6 questions scored out of 6 then averaged, value will range from 0-6, with 0 reflecting excellent asthma control and 6 very poor control.

  5. AQLQ [ Time Frame: 48 (or 56) weeks depending on group ]
    Change from baseline to end of study period. AQLQ consists of 32 questions related to quality of life scored out of 7, and then averaged. Total score is out of 7 with 1 being the worst and 7 the best. There is also a score between 1 and 7 for 4 subscales which cover areas of symptoms, activity limitation, emotional function and environmental stimuli. These subscales are also averaged over a number of questions with 1 being worst and 7 best.

  6. Change in treatment burden [ Time Frame: 48 or 56 weeks ]
    Has there been a change in short acting beta agonist use, inhaled corticosteroid dose, maintenance prednisolone dose, frequency of prednisolone boosts; i.e. is the patient requiring any more or less treatment for asthma control than at baseline. This will be assessed by asking the patient and completing an asthma medication use treatment chart

  7. Change in healthcare usage [ Time Frame: 48/56 weeks ]
    Number of episodes of in scheduled care, including GP or A&E attendances, hospital and ICU admission. This will be compared to pre-trial episodes of the same.

  8. Medical Research Council (MRC) dyspnoea score [ Time Frame: 48/56 weeks ]
    Change in score on MRC dyspnoea scale. This is a score from 1-5 used to grade degree of breathlessness, 1 is the best result, 5 is the worst (most breathless)

  9. Body mass index [ Time Frame: 48/56 weeks ]
    Change in body mass index over study period, calculated using height in metres and weight in kilograms to give BMI in kg/m2

  10. Inflammation [ Time Frame: 48/56 weeks ]
    Changes in Blood eosinophils and FENO

  11. Lung function [ Time Frame: 48/56 weeks ]
    Change in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC); lowest O2 saturation

  12. Exercise tolerance [ Time Frame: 48/56 weeks ]
    Change in 6MWT distance, modified Borg dyspnoea scale and lowest O2 saturation;

  13. Physical activity [ Time Frame: 48/56 weeks ]
    Change in actigraphy data

  14. Hospital anxiety and depression scale [ Time Frame: 48/56 weeks ]
    Change in score on HAD. This is a scale comprised of 14 questions where responses are graded from 0-3, with the responses then being totalled. A lower score is better, i.e. a higher score is indicative of more significant symptoms of anxiety and depression.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adults aged 18-80 year (smokers, ex-smokers and non-smokers)
  2. Confirmed asthma as per Global Initiative for Asthma (GINA) guidelines 2015[4] with characteristic symptoms and at least one of the following:

    • Airflow limitation - FEV1/FVC < 70% (at any time in the past) and 12% and 200ml increase in FEV1 in the preceding 5 years either:

      i. After inhaled/nebulised bronchodilator or 4+ weeks of anti- inflammatory treatment ii. Between visits

    • Positive bronchial challenge in the preceding 5 years:

    I. Histamine or methacholine provocation concentration causing a 20% drop in FEV1 (PC20) <8mg/ml ii. Provoking dose of mannitol required to cause a drop in FEV1 of 15% (PD15) mannitol <635mg

  3. Difficult asthma defined as per Scottish Intercollegiate Guidelines Network(SIGN)/British Thoracic Society(BTS) guideline 2014 as persistent symptoms and/or frequent asthma attacks despite treatment at step 4 or step 5 with either:

    • ACQ6>1.5
    • ≥2 systemic corticosteroid boosts in previous year
    • ≥1 hospitalization in previous year
  4. BMI≥25 kg/m2
  5. MRC dyspnoea scale ≥3/5

Exclusion Criteria:

  1. ICU admission +/- mechanical ventilation in the previous year for asthma exacerbation
  2. Respiratory tract infection requiring antibiotics or asthma exacerbation requiring corticosteroid boost in preceding 4 weeks
  3. Significant respiratory or other co-morbidity likely to influence the conduct of the study
  4. Pregnancy and breast feeding
  5. Severe and/or unstable cardiac disease
  6. Impaired mobility that impacts on ability to participate in physical training
  7. Recent (within the preceding 6 months) commencement of antifungal, biologic (omalizumab, lebrikizumab, mepolizumab) or Airsonett device; eligible if on treatment for >6months or discontinued >6 months ago.

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): NCT03630432


Contacts
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Contact: Douglas C Cowan 01412115451 douglas.cowan@ggc.scot.nhs.uk
Contact: Clare Ricketts clare.ricketts@nhs.net

Locations
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United Kingdom
Glasgow Royal Infirmary Recruiting
Glasgow, Scotland, United Kingdom, G31 2ER
Sponsors and Collaborators
NHS Greater Glasgow and Clyde

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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT03630432     History of Changes
Other Study ID Numbers: GN16RM503
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
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 NHS Greater Glasgow and Clyde:
Severe
Difficult
Overweight and obese

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