Dose-Ranging Study of MK-1029 in Adults with Persistent Asthma

• Research type

  Research Study

• Full title

  A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group, Adaptive-Design, Dose-Ranging Study of MK-1029 in Adult Subjects with Persistent Asthma

• IRAS ID

  108662

• Contact name

  Mark Blagden

• Sponsor organisation

  Merck Sharp & Dohme Corp.

• Eudract number

  2012-000643-27

• ISRCTN Number

  na

• Clinicaltrials.gov Identifier

  na

• Research summary

  This study will assess the safety, tolerability and effectiveness of various doses of the research study drug, MK-1029, in treating persistent asthma in adult patients , when taken on its own or when taken with a standard asthma medication (montelukast). Asthma is a highly prevalent disease associated with significant mortality, and accounting for high healthcare expenditures. This high burden is in part due to patients who are not well controlled on standard therapy. In addition, compliance with standard inhaler therapy is relatively low. Alternative options to inhalers include oral therapies; however current therapies are recognized to be less efficacious than inhaled agents. Therefore, there is a need for new, well-tolerated oral medications that effectively treat asthma, either alone or in combination with available therapies. MK-1029 is an oral medication. It is a potent and specific inhibitor of Chemoattractant Receptor-homologous molecules on Th2 cells (CRTH2), which have been implicated in the development of asthma. Initial preclinical and clinical studies have indicated that inhibition of CRTH2 may play an important role in the treatment of asthma. This international study will last for approximately 3 years in total. There are 6 participating UK sites and subjects will be recruited into the study for up to 19 weeks.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  12/EM/0399

• Date of REC Opinion

  3 Dec 2012

• REC opinion

  Further Information Favourable Opinion