Respiratory (asthma) Respiratory Asthma
Conditions
Interventions
Participants will be randomised to either an asthma self-management plan which includes an increase in inhaled corticosteroid or the same plan without an increase in inhaled corticosteroid.
Sponsors
University of Nottingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female aged 16 years and over 2. Clinician diagnosed asthma treated with a licensed dose of inhaled corticosteroid (i.e. step 2 to 4 of the British Thoracic Society [BTS] /Scottish Intercollegiate Guidelines Network [SIGN] guidelines) 3. One or more exacerbation in the last 12 months requiring treatment with systemic corticosteroids
Exclusion criteria
Exclusion criteria: Potential participants will be excluded on the basis of: 1. History more in keeping with smoking related chronic obstructive pulmonary disease [COPD] (smoked > 20 pack years, without evidence of significant reversibility and eosinophilia) 2. On maintenance oral steroids (i.e. step 5 BTS/SIGN guidelines) 3. Using a combination inhaler for both maintenance and relief treatment 4. Experienced an exacerbation within 4 weeks of randomisation 5. Pregnant women, lactating women or women who are planning to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first asthma exacerbation, defined as: the need for systemic corticosteroids and/or unscheduled health care consultation for asthma. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of participants who exacerbate, defined as: the need for systemic corticosteroids and/or unscheduled health care consultation for asthma (i.e. reaching zone 3 or 4 of the Asthma UK self-management plan). 2. Total number of exacerbations, defined as: the need for systemic corticosteroids and/or unscheduled health care consultation for asthma (i.e. reaching zone 3 or 4 of the Asthma UK self-management plan). 3. The number of participants using systemic corticosteroids for an acute exacerbation of asthma. 4. The number of participants requiring unscheduled healthcare consultation for asthma. 5. The total number of courses of systemic corticosteroids for an acute exacerbation of asthma. 6. The total number of unscheduled healthcare consultations for asthma. 7. The time to participants requiring systemic corticosteroids for an acute exacerbation of asthma. 8. The time to unscheduled healthcare consultation for asthma 9. The area under the morning peak flow curve over 2 weeks from the point of activating stage 2 of the asthma plan. 10. Change in Asthma Control Questionnaire 2 weeks after activating stage 2 of the self-management plan. 11. Cumulative dose of inhaled and systemic steroids used in the 12 months after randomisation. 12. Cost and resource audits of both trial arms will be reported as incremental cost per asthma exacerbation prevented and cost per quality adjusted life year gained (QALY). | — |
Countries
United Kingdom
Outcome results
None listed