Study of Clenil® Modulite® at different times of the day in Asthma
Research type
Research Study
Full title
Application of Chronotherapy to Asthma: Towards the Personalisation of Asthma Management. A randomised, mechanistic study of 400μg Clenil® Modulite® (Beclometasone dipropionate) in the morning versus in the afternoon versus 200μg twice a day, in Patients with Atopic Mild to Moderate Asthma
IRAS ID
273584
Contact name
David Rogers
Contact email
Sponsor organisation
The Medicines Evaluation Unit (MEU) Ltd. (Investigator led study)
Eudract number
2019-004309-28
Duration of Study in the UK
1 years, 9 months, 1 days
Research summary
Asthma is well-known to be a rhythmic inflammatory disease of the airways. Symptoms vary by time of day, and are often worse overnight or in the early hours of the morning. These rhythms in biological processes over 24 hours are known as circadian rhythms. Markers of airway inflammation also vary by time of day. The majority of asthma is mild/ moderate and is treated most effectively using short acting inhaled corticosteroids (ICS) (e.g. Clenil® Modulite® (Beclometasone dipropionate)) which is usually prescribed at relatively low doses (e.g. 200mcg, twice daily).
Chronotherapy is the treatment of a disease by aligning the time of drug administration with the body’s circadian rhythm, in an effort to enhance efficacy and reduce the side-effect profile. Inhaled corticosteroids treatments can be used for chronotherapy.This study will investigate whether it is more efficacious to take inhaled corticosteroid at various times in the day. Three regimes of Clenil® Modulite® will be tested: Once daily morning (400mcg) dosing regimen for 28 days, Once daily afternoon (400mcg) dosing regimen for 28 days and Twice daily (morning (200mcg) and evening (200mcg)) dosing regimen for 28 days in patients with atopic (allergic) mild to moderate asthma. The study will also be looking to see why the efficacy of inhaled corticosteroids varies by time of day in asthma and if it is possible to determine asthma traits based on circadian profile.
Comprehensive endpoints will be used to assess which dosing administration is better, including measuring changes in airway narrowing through the day, symptom scores, markers of inflammation (both clinical and novel) as well as measurements of circadian clock biology.
The study is an investigator led study, conducted at the Medicines Evaluation Unit (Manchester UK)
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
20/NW/0011
Date of REC Opinion
4 Mar 2020
REC opinion
Further Information Favourable Opinion