Effect of inhaled TD-8236 on allergen-induced asthmatic response
Research type
Research Study
Full title
A Randomised, Double-blind, Placebo-controlled, 3-period Crossover Study to Evaluate the Effects of Repeated Doses of Inhaled TD-8236 and Impact on Airway Responses Following Allergen Challenge in Patients with Asthma
IRAS ID
270774
Contact name
Nathan Pfeifer
Contact email
Sponsor organisation
Theravance Biopharma Ireland Limited
Eudract number
2019-002915-24
Duration of Study in the UK
0 years, 8 months, 13 days
Research summary
TD-8236 is a potential new inhaled drug that is being developed for the treatment of asthma.
Asthma is a lung disease associated with inflammation (swelling) of the airways. This swelling restricts the airflow to the lungs and can result in wheezing and shortness of breath. This can occur randomly or after being exposed to a trigger. Common triggers can include pollution, cold air, exercise and allergens (things which you are allergic to). Asthma symptoms are usually reversible with the use of medications designed to reduce the inflammation and open the airways. TD-8236 is hoped to reduce inflammation in the lungs. The study drug will be inhaled, which helps to directly target its activity to the lungs.
The purpose of this study, is to look at how effective the study drug is on patients with mild asthma. This will be done through measuring participants lung function response (change in breathing) to bronchial allergen challenges (breathing in a fine mist of the allergen that the participant is sensitive to), sputum (phlegm) sampling and blood sampling. The allergen test will help to measure the effect of the study drug through measuring the participants lung function response before and after intake of the study drug or placebo (‘dummy’ drug with no active ingredients) for 14 days. Participants' sputum samples will be analysed to look for changes in inflammatory cells following treatment with the study drug. Blood samples for Pharmacokinetic (PK) analysis will measure the levels of the study medication in the body and the time it takes for the body to break it down.
Each participant will take part in three separate 14 day treatment periods and will receive 2 different strengths of TD-8236 and the placebo.
REC name
London - Westminster Research Ethics Committee
REC reference
19/LO/1502
Date of REC Opinion
24 Oct 2019
REC opinion
Further Information Favourable Opinion