Mild asthma Respiratory Asthma
Conditions
Interventions
The trial is comparing a combined ICS/formoterol inhaler against the standard short-acting beta agonist (SABA) inhaler for symptom relief in patients with mild asthma taking low-dose inhaled corticost
increased if necessary up to 800 micrograms twice daily, dose to be adjusted as necessary. Please refer to the Easyhaler
Sponsors
University of Nottingham
Nottingham Clinical Trials Unit
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18 years and over with a clinical diagnosis of mild asthma* 2. Treated with low dose ICS** 3. Prescribed 11 or fewer canisters of salbutamol in the last 12 months*** 4. Ability to provide written informed consent *For the purposes of this trial “mild asthma” is defined as those patients with an existing clinical diagnosis of asthma (recorded in medical records) and treated with either a salbutamol alone or low-dose ICS and salbutamol. No further diagnostic tests will be undertaken to confirm asthma or its severity as we want the trial to be pragmatic in nature and, therefore, include patients who are currently treated for mild asthma. **low dose ICS is defined as up to and including 400 mcg BDP/day or equivalent ***Patients using salbutamol alone and using 3 or more inhalations per week can be included if started on low-dose ICS as part of their routine care for a minimum of 1 month before trial commencement.
Exclusion criteria
Exclusion criteria: 1. Salbutamol used only to prevent exercise-induced asthma 2. Other respiratory or non-respiratory diagnosis which will affect the trial interpretation in the view of the investigator (this includes, but is not limited to, smoking-related chronic obstructive pulmonary disease [COPD] and clinically significant bronchiectasis) 3. Participants who are pregnant or who are intending to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first severe asthma exacerbation, defined as treatment with systemic corticosteroids for an asthma worsening, for at least 3 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of severe asthma exacerbations in the 12-month period post-randomisation measured using monthly follow-up phone calls/texts and GP medical records 2. Number of hospital admissions for asthma in the 12-month period post-randomisation measured using GP medical records 3. Number of emergency department attendances for asthma in the 12-month period post-randomisation measured using GP medical records 4. Total SABA, ICS and ICS/formoterol inhalers prescribed in the 12-month period post-randomisation measured using GP medical records 5. Asthma control measured using Asthma Control Questionnaire – 5 (ACQ-5) at 12 months 6. Health-related quality of life measured using EQ5D-5I at baseline, 3, 6, 9 and 12 months 7. The acceptability of the new treatment assessed via an embedded qualitative study at week 1 and 9/12 months | — |
Countries
United Kingdom
Contacts
Public ContactMatthew Martin
Outcome results
None listed