AsthmaNCT03858608
Weight Loss for Uncontrolled Asthma Associated With Elevated BMI
A study testing Counterweight Plus and Usual asthma care in people with Asthma and Obesity, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Counterweight Plus and Usual asthma care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Aug 2019to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
- BMI ≥ 30 kg/m2
Who cannot join
- ICU admission +/- mechanical ventilation in the previous 6 months for asthma exacerbation
- Respiratory tract infection requiring antibiotics or asthma exacerbation requiring corticosteroid boost in preceding 4 weeks
- Significant respiratory or other co-morbidity likely to influence the conduct of the study
- Pregnancy and breast feeding
- Severe and/or unstable cardiac disease
- Recent (within the preceding 6 months) commencement of antifungal, biologic (omalizumab, lebrikizumab, mepolizumab) or "Airsonett" device; eligible if on treatment for > 6months or discontinued
- Current insulin use
- Current treatment with anti-obesity drugs
Trial locations and contacts
1 site in 1 country.
Clare Ricketts contact
United Kingdom1 site, 1 recruiting
- Recruiting
NHS Greater Glasgow and Clyde
Glasgow
Clare Ricketts, clare.ricketts@nhs.net
Douglas Cowan, 0141 211 5451
About this study
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
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.
Read more
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.
Read the detailed description
This study will be a unblinded, pragmatic, pilot, randomised, controlled trial of the Counterweight Plus programme versus usual care in individuals with difficult asthma associated with obesity. Eligible individuals will be identified through Difficult Asthma Clinics or ward admissions. Those wishing to participate will receive an information sheet and be invited to provide written informed consent prior to commencing the study.
Baseline Visit
Measurements taken at the baseline visit will include:
Demographics - age, gender, smoking history (current, ex, none, years since stopped, pack years), age at asthma diagnosis, duration of asthma, atopy, co-morbidities (allergic/perennial rhinitis, nasal polyps, nasal surgery, eczema, gastro-oesophageal reflux disease, diabetes, hypertension, cardiac disease, osteopenia/osteoporosis etc), medications (inhaled/nebulised short acting beta2-agonists (SABA), inhaled and oral corticosteroids etc), healthcare usage (oral corticosteroid (OCS) boosts, unscheduled General Practitioner (GP) or Accident + Emergency (A+E) attendances, hospital and Intensive Care Unit (ICU) admissions in preceding year), weight, height and BMI.
Questionnaires - Medical Research Council (MRC) dyspnoea scale, Asthma Control Questionnaire (ACQ6), Asthma Quality of Life Questionnaire (AQLQ), and Hospital Anxiety and Depression Scale (HAD).
Venepuncture - full blood count, urea and electrolytes, liver function tests, magnesium, bone profile, insulin, glucose, HbA1c, lipids, C-reactive Protein (CRP), Interleukin-6 (IL-6), leptin and adiponectin Lung Function/inflammometry - peak expiratory flow (PEF) (best of 3), Spirometry (pre- and post-bronchodilator), Fraction of exhaled nitric oxide (FENO) Exercise tolerance - 6 minute walk test (practice test and repeat test)[29], Modified Borg Dyspnoea Scale, pulse oximetry.
Physical Activity - actigraphy. Participants will be given the Actigraph device and asked to wear it continuously for 7 days on their non-dominant wrist, then hand it back.
Participants will be provided with a Personalized Asthma Management Plan, and Symptoms Diary that includes SABA use and other healthcare usage (oral corticosteroid (OCS) boosts, unscheduled GP or A+E attendances, hospital and ICU admissions); inhaler technique will be corrected if necessary.
Participants will be randomized 1:1 to Group A and Group B. Group A will enter the Counterweight Plus programme and Group B will enter the usual care arm.
Participants will return for Visit 2 at 16 weeks and Visit 3 at 52 weeks.
Measurements taken at Visits 2 and 3 will include:
Demographics - medications (inhaled/nebulised short acting beta2-agonists (SABA), inhaled and oral corticosteroids etc), healthcare usage (oral corticosteroid (OCS) boosts, unscheduled GP or A+E attendances, hospital and ICU admissions since last visit), weight, height, and BMI.
Questionnaires - MRC dyspnoea scale, Asthma Control Questionnaire (ACQ6), Asthma Quality of Life Questionnaire (AQLQ), and Hospital Anxiety and Depression Scale (HAD).
Venepuncture - full blood count, urea and electrolytes, liver function tests, magnesium, bone profile, insulin, glucose, HbA1c, lipids, CRP, IL-6, leptin and adiponectin Lung Function/inflammometry - PEF (best of 3), Spirometry (pre- and post-bronchodilator), Fraction of exhaled nitric oxide (FENO) Exercise tolerance - 6 minute walk test, Modified Borg Dyspnoea Scale, pulse oximetry.
Physical Activity - actigraphy Visits will be postponed by 4 weeks in the event of exacerbation or respiratory infection. Throughout the study period changes to asthma medications will be allowed as clinically indicated.
Rescue Package for weight regain or re-emergence of diabetes Some patients find weight maintenance difficult, some relapse temporarily and gain weight rapidly. Others may tend to let things slip more gradually. Pilot studies showed the value of a sympathetic, but firm approach to relapse/regain management. If weight regains occurs in TDR randomised participants, or if diabetes is found to have returned (HbA1c risen above 6.5%) at any time during the 18 month weight loss maintenance stage, 'rescue plans' for weight gain prevention will be offered.
- Weight regain of >2kg: offer the use of TDR to replace one main-meal per day for 4 weeks, and offer orlistat 120 mg tid, with each meal.
- Weight gain of >4kg, or to <15kg below starting weight or if diabetes recurs: offer 4 weeks TDR with fortnightly weekly practice nurse/dietitian review and then a 2-4 week food re-introduction (adding 1 meal/week as before). Lowfat dietary advice and physical activity will be reinforced for weight maintenance and orlistat treatment will be offered.
This package can be repeated as required in each year of the maintenance phase.
- Being tested
- Counterweight Plus, Usual asthma care
- Keywords
- Weight loss, Counterweight Plus
- Medical subject headings
- Asthma, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counterweight PlusDietary supplement
Total diet replacement followed by food reintroduction and weight maintenance.
Usual asthma careOther
Usual asthma management
| Study group | Role | What they receive |
|---|---|---|
| Counterweight Plus | Experimental | 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%] Receives: Dietary Supplement: Counterweight Plus |
| Usual asthma care | Active comparator | Usual asthma management Receives: Other: Usual asthma care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control overall change
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
Measured: Baseline to week 16
Secondary outcomes (9)
Asthma control change comparing groups
% 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
Measured: Baseline to week 16
Asthma Quality of Life overall change
Change in AQLQ score in intervention group versus usual care group. Score range 32 - 224 with lower scores representing a worse outcome
Measured: Baseline to week 16
Asthma Quality of Life improvement: %
% 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
Measured: Baseline to seek 16
Asthma control long term
Change in ACQ6 score from baseline to 1 year in intervention group- Score range 0 - 36 with higher scores representing a worse outcome
Measured: Baseline to 52 weeks
Asthma quality of life long term: AQLQ score
Change in AQLQ score
Measured: Baseline to 52 weeks
Treatment burden
Change in asthma medication use
Measured: Baseline to 16 weeks
Treatment burden long term
Change in asthma medication use
Measured: Baseline to 52 weeks
Healthcare use
Change in number of unscheduled medical attendances
Measured: Baseline to 16 weeks
Healthcare use long term
Change in number of unscheduled medical attendances
Measured: Baseline to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start12 Aug 2019
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Unblinded, pragmatic, pilot, randomised, controlled trial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Douglas Cowan, Principal investigator, NHS Greater Glasgow and Clyde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858608
- Sponsor's protocol ID
- GN18RM508
- Status last verified
- Apr 2023
- First submitted
- 27 Feb 2019
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sharma V, Ricketts HC, McCombie L, Brosnahan N, Crawford L, Slaughter L, Goodfellow A, Steffensen F, Chaudhuri R, Lean MEJ, Cowan DC. A 1-Year Weight Management Program for Difficult-to-Treat Asthma With Obesity: A Randomized Controlled Study. Chest. 2025 Jan;167(1):42-53. doi: 10.1016/j.chest.2024.09.042. Epub 2024 Oct 18.
PubMed 39427706Sharma V, Ricketts HC, McCombie L, Brosnahan N, Crawford L, Slaughter L, Goodfellow A, Steffensen F, Buchan DS, Chaudhuri R, Lean MEJ, Cowan DC. A Total Diet Replacement Weight Management Program for Difficult-to-Treat Asthma Associated With Obesity: A Randomized Controlled Feasibility Trial. Chest. 2023 May;163(5):1026-1037. doi: 10.1016/j.chest.2023.01.015. Epub 2023 Jan 14.
PubMed 36649753
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03858608
- Acronym / sponsor ID
- GN18RM508
- Keywords
- Weight loss, Counterweight Plus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 12 Aug 2019 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be a unblinded, pragmatic, pilot, randomised, controlled trial of the Counterweight Plus programme versus usual care in individuals with difficult asthma associated with obesity. Eligible individuals will be identified through Difficult Asthma Clinics or ward admissions. Those wishing to participate will receive an information sheet and be invited to provide written informed consent prior to commencing the study.
Baseline Visit
Measurements taken at the baseline visit will include:
Demographics - age, gender, smoking history (current, ex, none, years since stopped, pack years), age at asthma diagnosis, duration of asthma, atopy, co-morbidities (allergic/perennial rhinitis, nasal polyps, nasal surgery, eczema, gastro-oesophageal reflux disease, diabetes, hypertension, cardiac disease, osteopenia/osteoporosis etc), medications (inhaled/nebulised short acting beta2-agonists (SABA), inhaled and oral corticosteroids etc), healthcare usage (oral corticosteroid (OCS) boosts, unscheduled General Practitioner (GP) or Accident + Emergency (A+E) attendances, hospital and Intensive Care Unit (ICU) admissions in preceding year), weight, height and BMI.
Questionnaires - Medical Research Council (MRC) dyspnoea scale, Asthma Control Questionnaire (ACQ6), Asthma Quality of Life Questionnaire (AQLQ), and Hospital Anxiety and Depression Scale (HAD).
Venepuncture - full blood count, urea and electrolytes, liver function tests, magnesium, bone profile, insulin, glucose, HbA1c, lipids, C-reactive Protein (CRP), Interleukin-6 (IL-6), leptin and adiponectin Lung Function/inflammometry - peak expiratory flow (PEF) (best of 3), Spirometry (pre- and post-bronchodilator), Fraction of exhaled nitric oxide (FENO) Exercise tolerance - 6 minute walk test (practice test and repeat test)[29], Modified Borg Dyspnoea Scale, pulse oximetry.
Physical Activity - actigraphy. Participants will be given the Actigraph device and asked to wear it continuously for 7 days on their non-dominant wrist, then hand it back.
Participants will be provided with a Personalized Asthma Management Plan, and Symptoms Diary that includes SABA use and other healthcare usage (oral corticosteroid (OCS) boosts, unscheduled GP or A+E attendances, hospital and ICU admissions); inhaler technique will be corrected if necessary.
Participants will be randomized 1:1 to Group A and Group B. Group A will enter the Counterweight Plus programme and Group B will enter the usual care arm.
Participants will return for Visit 2 at 16 weeks and Visit 3 at 52 weeks.
Measurements taken at Visits 2 and 3 will include:
Demographics - medications (inhaled/nebulised short acting beta2-agonists (SABA), inhaled and oral corticosteroids etc), healthcare usage (oral corticosteroid (OCS) boosts, unscheduled GP or A+E attendances, hospital and ICU admissions since last visit), weight, height, and BMI.
Questionnaires - MRC dyspnoea scale, Asthma Control Questionnaire (ACQ6), Asthma Quality of Life Questionnaire (AQLQ), and Hospital Anxiety and Depression Scale (HAD).
Venepuncture - full blood count, urea and electrolytes, liver function tests, magnesium, bone profile, insulin, glucose, HbA1c, lipids, CRP, IL-6, leptin and adiponectin Lung Function/inflammometry - PEF (best of 3), Spirometry (pre- and post-bronchodilator), Fraction of exhaled nitric oxide (FENO) Exercise tolerance - 6 minute walk test, Modified Borg Dyspnoea Scale, pulse oximetry.
Physical Activity - actigraphy Visits will be postponed by 4 weeks in the event of exacerbation or respiratory infection. Throughout the study period changes to asthma medications will be allowed as clinically indicated.
Rescue Package for weight regain or re-emergence of diabetes Some patients find weight maintenance difficult, some relapse temporarily and gain weight rapidly. Others may tend to let things slip more gradually. Pilot studies showed the value of a sympathetic, but firm approach to relapse/regain management. If weight regains occurs in TDR randomised participants, or if diabetes is found to have returned (HbA1c risen above 6.5%) at any time during the 18 month weight loss maintenance stage, 'rescue plans' for weight gain prevention will be offered.
- Weight regain of >2kg: offer the use of TDR to replace one main-meal per day for 4 weeks, and offer orlistat 120 mg tid, with each meal.
- Weight gain of >4kg, or to <15kg below starting weight or if diabetes recurs: offer 4 weeks TDR with fortnightly weekly practice nurse/dietitian review and then a 2-4 week food re-introduction (adding 1 meal/week as before). Lowfat dietary advice and physical activity will be reinforced for weight maintenance and orlistat treatment will be offered.
This package can be repeated as required in each year of the maintenance phase.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Unblinded, pragmatic, pilot, randomised, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Counterweight Plus | Experimental | Dietary Supplement: Counterweight PlusTotal 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%] |
| Usual asthma care | Active comparator | Other: Usual asthma careUsual asthma management |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmed asthma as per Global Initiative for Asthma (GINA) guidelines 2015 with characteristic symptoms and at least one of the following:
- 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:
- BMI ≥ 30 kg/m2
Key exclusion criteria (8 listed)
- ICU admission +/- mechanical ventilation in the previous 6 months for asthma exacerbation
- Respiratory tract infection requiring antibiotics or asthma exacerbation requiring corticosteroid boost in preceding 4 weeks
- Significant respiratory or other co-morbidity likely to influence the conduct of the study
- Pregnancy and breast feeding
- Severe and/or unstable cardiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counterweight PlusTotal diet replacement followed by food reintroduction and weight maintenance. | Dietary supplement | Counterweight Plus |
| Usual asthma careUsual asthma management | Other | Usual asthma care |
Primary outcome
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
9 secondary outcomes
Asthma control change comparing groups
Time frame: Baseline to week 16
Asthma Quality of Life overall change
Time frame: Baseline to week 16
Asthma Quality of Life improvement: %
Time frame: Baseline to seek 16
Asthma control long term
Time frame: Baseline to 52 weeks
Asthma quality of life long term: AQLQ score
Time frame: Baseline to 52 weeks
Treatment burden
Time frame: Baseline to 16 weeks
Treatment burden long term
Time frame: Baseline to 52 weeks
Healthcare use
Time frame: Baseline to 16 weeks
Healthcare use long term
Time frame: Baseline to 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Derived from this study: PubMed 39427706Sharma V, Ricketts HC, McCombie L, Brosnahan N, Crawford L, Slaughter L, Goodfellow A, Steffensen F, Chaudhuri R, Lean MEJ, Cowan DC. A 1-Year Weight Management Program for Difficult-to-Treat Asthma With Obesity: A Randomized Controlled Study. Chest. 2025 Jan;167(1):42-53. doi: 10.1016/j.chest.2024.09.042. Epub 2024 Oct 18.
- Derived from this study: PubMed 36649753Sharma V, Ricketts HC, McCombie L, Brosnahan N, Crawford L, Slaughter L, Goodfellow A, Steffensen F, Buchan DS, Chaudhuri R, Lean MEJ, Cowan DC. A Total Diet Replacement Weight Management Program for Difficult-to-Treat Asthma Associated With Obesity: A Randomized Controlled Feasibility Trial. Chest. 2023 May;163(5):1026-1037. doi: 10.1016/j.chest.2023.01.015. Epub 2023 Jan 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clare Ricketts contact
Douglas Cowan principal investigator
NHS Greater Glasgow and Clyde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counterweight Plus and Usual asthma care in people with Asthma and Obesity, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Douglas Cowan (0141 211 5451, douglas.cowan@ggc.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control overall change (time frame: Baseline to week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03858608, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.