Asthma Respiratory Asthma
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Full practice registration for a minimum of 12 months prior to enrolment 2. Age 16-70 years 3. Physician diagnosed asthma in medical records 4. One or more anti-asthma medication prescription in the previous year (determined from the physician prescribing records) 5. Impaired asthma-related health status (Asthma Quality of Life Questionnaire score of < 5.5) 6. Informed consent
Exclusion criteria
Exclusion criteria: 1. Asthma judged at the baseline assessment not to be dangerously unstable and in need of urgent medical review (if unstable asthma is found, the patient will be referred back to usual primary care clinician for review) 2. Documented diagnosis of Chronic Obstructive Pulmonary Disease (COPD) We aim to allow broad entry criteria (with inclusion of smokers, and not insisting on physiological demonstration of reversible airflow obstruction) in order to allow generalisability of research findings to mild-to-moderate UK asthma populations treated in primary care National Health Service (NHS) practice.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Analysis of the between-group (Intention-To-Treat (ITT)) change in asthma-specific health status [AQLQ (short version) score]. Outcome measures will be between-group and within-group changes from baseline to the end of the study (12 months). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Asthma Control Questionnaire score 2. Lung function [Forced expiratory volume in one second (FEV1), ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs (FEV1/FVC ratio), peak expiratory flow rate (PEFR)] 3. Fraction of exhaled nitric oxide 4. Health status (EuroQOL) 5. Anxiety and depression scores (HAD questionnaire) 6. Hyperventilation (Nijmegen questionnaire) 6. Oral corticosteroid courses 7. Bronchodilator use 8. Asthma related health resource use 9. Smoking status 10. Cost effectiveness/utility 11. Patient reported process evaluations (questionnaires) and estimates of adherence (use of exercises) | — |
Countries
United Kingdom