Clinical trial · Interventional
Pulmonary Rehabilitation for Uncontrolled Asthma Associated With Elevated BMI
A Pragmatic, Randomised, Controlled, Trial of the Effect of a Tailored Pulmonary Rehabilitation Package in Uncontrolled Asthma Associated With Elevated Body Mass Index
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Asthma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pulmonary rehabilitation | Behavioral | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group A
- description
- Immediate 8 week course of pulmonary rehabilitation
- interventionNames
- Behavioral: Pulmonary rehabilitation
- type
- PLACEBO_COMPARATOR
- label
- Group B
- description
- Initial 8 weeks of usual care
- interventionNames
- Other: Usual Care
Primary outcomes (1)
- measure
- AQLQ- Asthma quality of life questionnaire
- timeFrame
- 8 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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.References
Publications (1)
- DERIVEDRicketts HC, Sharma V, Steffensen F, Goodfellow A, Mackay E, MacDonald G, Buchan DS, Chaudhuri R, Cowan DC. A pragmatic randomised controlled trial of tailored pulmonary rehabilitation in participants with difficult-to-control asthma and elevated body mass index. BMC Pulm Med. 2022 Sep 24;22(1):363. doi: 10.1186/s12890-022-02152-2. PMID 36153525