Effect of a novel therapy for asthma (MK-1029) on allergen challenge

• Research type

  Research Study

• Full title

  A Two-Part, Multicenter, Randomized, Clinical Trial to Study the Effects of Multiple Doses of MK-1029 on the Late Asthmatic Response to Lung Allergen Challenge in Asthmatics

• IRAS ID

  72853

• Contact name

  Leonard Siew

• Sponsor organisation

  Merck Sharp & Dohme Corp.

• Eudract number

  2010-022391-31

• ISRCTN Number

  xx

• Research summary

  The study medicine is a new drug that has potential value in the treatment of allergic asthma (intermittent narrowing of the airways due to allergy). The purpose of this study is to examine the effects of the study medicine on the response to inhaled allergen (house dust mite) in asthmatic patients. We will be investigating the safety and tolerability of the study medicine and how much of it enters the blood circulation and what it is broken down into by collecting blood samples. The asthmatic airways inflammation will be assessed by collecting blood which will be analysed for mRNA (messenger ribonucleic acid) and CD11b expression. mRNA is used by the body to produce a variety of proteins, which are critical in the allergic response. CD11b is a protein which is expressed by cells involved in an allergic response. A blood sample for genetic tests will be collected to determine how genes affect the way the body handles the study drug. The effect of the study medicine on the response to an allergen will be compared to inhaled mometasone furoate. Inhaled mometasone furoate is an inhaled steroid, which is used in the routine treatment of asthma. Inhaled steroids act directly on the airways reducing airway inflammation that occurs in patients who have asthma. Approximately 15 male and female patients (of non-childbearing potential) with mild, persistent, well-controlled allergic asthma will be enrolled into the study, which will be approximately 22 weeks in duration. In addition, up to 6 patients will be enrolled onto a short pilot part of the study where they will mimic the procedures conducted in the study main but will not receive any study medication. This is in order for the investigators to verify that the study procedures are being carried out satisfactorily. The pilot part of the study consists of one study period involving 1 day of outpatient procedures followed by a 2 day admission. The main study is being conducted in 2 centres, London and Manchester. It consists of outpatient-screening visit(s) followed by 5 treatment periods and an outpatient follow-up visit. Each treatment period will be 8 days in duration. At the London site each period consists of 4 days of outpatient dosing following which there will be a 3 day admission and an out-patient visit. At the Manchester site each period consists of 4 days of outpatient dosing following which there will be a 2 day admission and 2 out-patient visits.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  11/H0802/11

• Date of REC Opinion

  29 Mar 2011

• REC opinion

  Further Information Favourable Opinion