Study of ADC3680B in patients with mild to moderate asthma
Research type
Research Study
Full title
A Randomised, Placebo-Controlled, Double-Blind, Parallel Group Phase II Study to Assess the Safety, Tolerability and Pharmacokinetics of ADC3680B in Subjects with Partly Controlled Atopic Asthma.
IRAS ID
85452
Contact name
Dave Singh
Contact email
Sponsor organisation
Pulmagen Therapeutics Ltd.
Eudract number
2011-002816-97
ISRCTN Number
0
Clinicaltrials.gov Identifier
0
Research summary
ADC3680B is a CRTh2 receptor antagonist and is a potential new treatment for asthma. An oral tablet, ADC3680B is designed to be taken once a day to reduce the inflammation in the lungs that is typical of asthma and as a consequence it may improve symptoms and asthma control. ADC3680B has already been tested in healthy subjects and has been shown to be safe and well tolerated. We now wish to test whether it is equally safe in subjects with asthma.Subjects with allergic asthma whose symptoms are not well-controlled will be screened to assess their suitability. Subjects who are suitable will be treated with either ADC3680B or a dummy tablet once daily for 28 days.At the start of treatment, subjects will stay in the study unit for 24 hours. Blood samples will be taken to measure levels of drug in the blood. There will be two single appointments 7 and 14 days later. After 28 days of treatment, subjects will return to the unit for a further 48 hours and more blood samples will be taken to measure drug levels. Blood tests will also be done at some of these visits to check that the drug is safe and to see whether the treatment has any effect on some of the cells and proteins in blood that are associated with inflammation and asthma. At each visit, the effect of the drug on breathing (lung function) and asthma symptoms will also be assessed. The study is sponsored by Pulmagen Therapeutics and is being conducted at two centres, one in Manchester and the other in Belfast.
REC name
North West - Haydock Research Ethics Committee
REC reference
11/NW/0591
Date of REC Opinion
22 Sep 2011
REC opinion
Further Information Favourable Opinion