A new relief inhaler for mild asthma

Phase 3

• Conditions: Mild asthma; Respiratory; Asthma

• Registration Number: ISRCTN29579666
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-13
• Last Update Posted: 20 June 2023
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 2300

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to first severe asthma exacerbation, defined as treatment with systemic corticosteroids for an asthma worsening, for at least 3 days

Secondary Outcome Measures

Name	Time	Method
1. Number of severe asthma exacerbations in the 12-month period post-randomisation measured using monthly follow-up phone calls/texts and GP medical records2. Number of hospital admissions for asthma in the 12-month period post-randomisation measured using GP medical records3. Number of emergency department attendances for asthma in the 12-month period post-randomisation measured using GP medical records4. Total SABA, ICS and ICS/formoterol inhalers prescribed in the 12-month period post-randomisation measured using GP medical records5. Asthma control measured using Asthma Control Questionnaire – 5 (ACQ-5) at 12 months6. Health-related quality of life measured using EQ5D-5I at baseline, 3, 6, 9 and 12 months7. The acceptability of the new treatment assessed via an embedded qualitative study at week 1 and 9/12 months