Asthma Clinical Trial
— PRODA01Official title:
A Pragmatic, Randomised, Controlled, Trial of the Effect of a Tailored Pulmonary Rehabilitation Package in Uncontrolled Asthma Associated With Elevated Body Mass Index
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)
Status | Recruiting |
Enrollment | 180 |
Est. completion date | December 1, 2019 |
Est. primary completion date | May 10, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Glasgow Royal Infirmary | Glasgow | Scotland |
Lead Sponsor | Collaborator |
---|---|
NHS Greater Glasgow and Clyde |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AQLQ- Asthma quality of life questionnaire | 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. | 8 weeks | |
Secondary | AQLQ- asthma quality of life questionnaire | 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. | 8 weeks | |
Secondary | ACQ6- asthma control questionnaire 6 | 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. | 8 weeks | |
Secondary | ACQ6- asthma control questionnaire 6 | 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. | 8 weeks | |
Secondary | ACQ6- asthma control questionnaire 6 | 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. | 48 (or 56) weeks depending on group | |
Secondary | AQLQ | 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. | 48 (or 56) weeks depending on group | |
Secondary | Change in treatment burden | 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 | 48 or 56 weeks | |
Secondary | Change in healthcare usage | 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. | 48/56 weeks | |
Secondary | Medical Research Council (MRC) dyspnoea score | 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) | 48/56 weeks | |
Secondary | Body mass index | Change in body mass index over study period, calculated using height in metres and weight in kilograms to give BMI in kg/m2 | 48/56 weeks | |
Secondary | Inflammation | Changes in Blood eosinophils and FENO | 48/56 weeks | |
Secondary | Lung function | Change in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC); lowest O2 saturation | 48/56 weeks | |
Secondary | Exercise tolerance | Change in 6MWT distance, modified Borg dyspnoea scale and lowest O2 saturation; | 48/56 weeks | |
Secondary | Physical activity | Change in actigraphy data | 48/56 weeks | |
Secondary | Hospital anxiety and depression scale | 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. | 48/56 weeks |
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