Effects of GPD-1116 on response to allergen in asthma patients.
Research type
Research Study
Full title
Phase IIa study to evaluate the effects of GPD-1116 on late phase asthmatic response to allergen challenge in asthmatic patients.
IRAS ID
7412
Contact name
Darren Wilbraham
Sponsor organisation
ASKA Pharmaceutical Co., Ltd.
Eudract number
2008-005813-23
ISRCTN Number
No number provided
Clinicaltrials.gov Identifier
No number provided
Research summary
The study drug is being developed to treat symptoms of Chronic Obstructive Pulmonary Disease (like emphysema) and asthma in patients It has anti-inflammatory effects (reduces inflammation in the lungs) and bronchodilating (opens the airways in the lungs) activity. This is not the first time the study drug is administered to humans. So far there have been two studies in healthy volunteers conducted. The study drug was found to be well tolerated. This study objective is to find out what the effects of repeated doses of the study drug would have on asthmatic subjects when challenged with an allergen (protein that is responsible for causing an allergic reaction e.g. grass pollens, house dust mite and cat hair). The study will take place at Quintiles Limited, Guy-s Drug research Unit. It will involve subjects with mild to moderate asthma. For each subject the study will usually involve three screening visits (the second visit may involve an overnight stay in the Unit), additional screening days may be required formsubject safety to complete all required tests and two treatment periods (Period 1 and Period 2) which are separated by 2-week interval. Each period consists of 15 days of dosing and there will be a combination of staying overnight in the Unit and outpatient visits. Upon completion of these treatment periods, there will also be a final follow-up visit 7 days after discharge from Period 2.
REC name
London - London Bridge Research Ethics Committee
REC reference
08/H0804/143
Date of REC Opinion
24 Nov 2008
REC opinion
Further Information Favourable Opinion