A Single Dose Study of MK-8351 in a Lung Allergen Challenge
Research type
Research Study
Full title
A Multicenter Randomized Clinical Trial to Study the Effects of Single Doses of MK-8351 on the Early Asthmatic Response to a Lung Allergen Challenge
IRAS ID
135342
Contact name
Leonard Siew
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2013-001587-28
ISRCTN Number
N/A
Research summary
Approximately 5-10% of patients with asthma have moderate to severe disease that remains poorly controlled. As the medical needs of these patients are not met by available treatment options, their uncontrolled asthma results in frequent symptoms as well as increased hospitalisations. This group of patients consumes greater than 50% of health care costs attributed to this disease.
This study drug, MK-8351, is being developed as an inhaled dry powder therapy for the treatment of moderate to severe asthma. A new asthma management inhaler could provide significant clinical benefits for asthmatics that remain uncontrolled despite standard care of therapies.
The purpose of this study is to assess the effect of a single dose of the study drug on the change in asthmatic response, specifically early asthmatic response (EAR) as compared to placebo (no active ingredient). The study drug is thought to block the key signalling pathways which lead to the common symptoms of asthma.
Patients enrolled on this study will be randomised into one of three groups. Across three time-points, these three groups will receive either a high dose of the study drug, a low dose of the study drug or a placebo. These groups will then swap treatments twice (with a washout period in between) so all participants receive all treatments.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
13/SC/0400
Date of REC Opinion
2 Sep 2013
REC opinion
Further Information Favourable Opinion