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Weight Loss for Uncontrolled Asthma Associated With Elevated BMI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03858608
Recruitment Status : Recruiting
First Posted : March 1, 2019
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Brief Summary:

Weight loss for uncontrolled asthma associated with elevated BMI. Asthma is a common condition with different types recognised that have variable responses to current treatments. It is often poorly controlled and there is a need to discover new treatments. Obesity is common in asthma and is associated with increase in symptoms, poorer asthma control and quality of life, and increased healthcare utilisation and treatment burden. The Counterweight Plus programme is a safe, evidence-based non-surgical intervention that is associated with sustained weight losses of up to 15% in obese individuals but its effects in asthma have not been tested. Our study aims to evaluate the impact of this intervention in individuals with difficult asthma associated with obesity.

The Counterweight Plus programme includes a total diet replacement (TDR) phase (12 weeks) followed by structured food reintroduction (6 weeks) and long term weight loss maintenance (34 weeks) and will be provided by Dieticians trained in the delivery of this intervention. Participants will attend fortnightly clinic reviews with Dieticians during the first 18 weeks and then monthly clinic reviews during the weight loss maintenance period.

Participants will be randomised to Counterweight Plus programme or usual care (control) and followed for 1 year with study visits at baseline, 4 months and 1 year. During study visits participants will be invited to complete questionnaires, provide a blood sample, perform breathing tests and a walking test, and wear an activity monitor for one week.

If the Counterweight Plus programme is proven to be of benefit in this patient group, this may lead to service development so that this intervention may be made available to similar patients in the future within the clinical setting.


Condition or disease Intervention/treatment Phase
Asthma Obesity Dietary Supplement: Counterweight Plus Other: Usual asthma care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Unblinded, pragmatic, pilot, randomised, controlled trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pragmatic, Randomised, Controlled, Trial of the Effect of the Counterweight Plus Weight Management Programme in Uncontrolled Asthma Associated With Elevated Body Mass Index
Actual Study Start Date : August 12, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Counterweight Plus

Total Diet Replacement phase (0-12 weeks) 825-853kcal/day low energy liquid diet (LELD) for 12 weeks Food Reintroduction phase (13-18 weeks) Wk 13: 400kcal/d LELD + 1 low-fat meal/day (c. 360-400 kcal) + 2 servings of fruit, 200mls skimmed milk and free vegetables. Total intake: 1000kcal/day Wk 15: 200kcal/d LELD + 2 low-fat meals/day (c. 720-800 kcal) + 2 servings of fruit, 200mls skimmed milk and free vegetables. Total intake: 1200kcal/day.

Wk 17: 3 low-fat meals per day (c.1080-1200 kcal) + 2 servings of fruit, 200mls skimmed milk and free vegetables. Total intake: 1400kcal/day.

Weight maintenance phase (wks 19-52) Low-fat healthy eating weight loss maintenance intervention [target below 30% energy from fat, with flexibility to optimise individual compliance, to a maximum of 35%]

Dietary Supplement: Counterweight Plus
Total diet replacement followed by food reintroduction and weight maintenance.

Active Comparator: Usual asthma care
Usual asthma management
Other: Usual asthma care
Usual asthma management




Primary Outcome Measures :
  1. Asthma Control overall change [ Time Frame: Baseline to week 16 ]
    Change in score of ACQ6 (Asthma Control Questionnaire 6) in intervention group versus usual care group. Score range 0 - 36 with higher scores representing a worse outcome


Secondary Outcome Measures :
  1. Asthma control change comparing groups [ Time Frame: Baseline to week 16 ]
    % of individuals with greater than or equal to 0.5 point change in ACQ6 in intervention group compared to control group. Change in score of ACQ6 (Asthma Control Questionnaire 6) in intervention group versus usual care group. Score range 0 - 36 with higher scores representing a worse outcome

  2. Asthma Quality of Life overall change [ Time Frame: Baseline to week 16 ]
    Change in AQLQ score in intervention group versus usual care group. Score range 32 - 224 with lower scores representing a worse outcome

  3. Asthma Quality of Life improvement: % [ Time Frame: Baseline to seek 16 ]
    % of individuals with greater than or equal to 0.5 point change in ACQ6 in intervention group compared to control group. Score range 32 - 224 with lower scores representing a worse outcome

  4. Asthma control long term [ Time Frame: Baseline to 52 weeks ]
    Change in ACQ6 score from baseline to 1 year in intervention group- Score range 0 - 36 with higher scores representing a worse outcome

  5. Asthma quality of life long term: AQLQ score [ Time Frame: Baseline to 52 weeks ]
    Change in AQLQ score

  6. Treatment burden [ Time Frame: Baseline to 16 weeks ]
    Change in asthma medication use

  7. Treatment burden long term [ Time Frame: Baseline to 52 weeks ]
    Change in asthma medication use

  8. Healthcare use [ Time Frame: Baseline to 16 weeks ]
    Change in number of unscheduled medical attendances

  9. Healthcare use long term [ Time Frame: Baseline to 52 weeks ]
    Change in number of unscheduled medical attendances



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Confirmed asthma as per Global Initiative for Asthma (GINA) guidelines 2015 with characteristic symptoms and at least one of the following:

    • Reversible airflow limitation - 12% and 200ml increase in forced expiratory volume (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. Provocation concentration (PC20) methacholine or histamine <8mg/ml ii. Provocative dose (PD15) mannitol <635mg

  2. 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
  3. BMI ≥ 30 kg/m2

Exclusion Criteria:

  1. ICU admission +/- mechanical ventilation in the previous 6 months 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. Recent (within the preceding 6 months) commencement of antifungal, biologic (omalizumab, lebrikizumab, mepolizumab) or "Airsonett" device; eligible if on treatment for > 6months or discontinued
  7. Current insulin use
  8. Current treatment with anti-obesity drugs

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): NCT03858608


Contacts
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Contact: Douglas Cowan 0141 211 5451 douglas.cowan@ggc.scot.nhs.uk
Contact: Clare Ricketts clare.ricketts@nhs.net

Locations
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United Kingdom
NHS Greater Glasgow and Clyde Recruiting
Glasgow, United Kingdom
Contact: Clare Ricketts       clare.ricketts@nhs.net   
Contact: Douglas Cowan    0141 211 5451      
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
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Principal Investigator: Douglas Cowan NHS Greater Glasgow and Clyde
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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT03858608    
Other Study ID Numbers: GN18RM508
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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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:
Weight loss
Counterweight Plus
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