Randomised controlled trial of a new relief inhaler in mild asthma: the RELIEF trial

niversity of Nottingham0 sites2,300 target enrollmentFebruary 13, 2023

Overview

No summary available.

Registry

who.int

Start Date

February 13, 2023

End Date

November 30, 2025

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•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.

•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