DB Crossover Study to Evaluate the Efficacy of JNJ40929837 in Asthma

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo- and Active-Controlled Crossover Study to Evaluate the Efficacy of JNJ 40929837 for the Treatment of Asthma Using a Bronchial Allergen Challenge Model

• IRAS ID

  62922

• Contact name

  John Lambert

• Sponsor organisation

  Johnson&Johnson Pharmaceutical PRD

• Eudract number

  2010-022437-28

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The study will evaluate how effective the experimental medication, JNJ 40929837, intended for the treatment of asthma is.It will be performed in approximately 18 non'smoking, generally healthy female subjects, aged 18 to 55 years, who have stable, mild, atopic asthma.Several preclinical and clinical findings suggest that inhibition of LTB4 formation by JNJ 40929837 will have therapeutic benefit in asthma.LTB4 is an activator of the immune system response which causes the symptoms of asthma.An oral therapy which could effectively treat moderate to severe asthma and reduce corticosteroid requirements would addriss unmet medical needs.The study will be conducted at two clinical research centres, PAREXEL Early Phase Clinical Unit, Northwickpark Hospital, Harrow and PAREXEL Early Phase Clinical Unit, Klinikum Westend, Berlin.Subjects will receive all 3 treatments in differing sequence in each of the 7-day treatment periods (three 7-day treatment periods with a 14-day washout period between treatment periods), i.e. JNJ 40929837 (test medication), montelukast (a registered asthma medication), and placebo (non-active medication).Subjects will undergo the following procedures during the study: medical history and demographic data will be collected, physical examinations, electrocardiograms (ECGs) and continuous ECG monitoring (telemetry) will be performed, height and weight will be measured, blood Pressure, heart rate, respiratory rate, temperature measurements and lung function tests will be done, different kinds of urine/breath and blood safety tests will be performed, blood samples for the measurement of study drug concentration, sputum, urine and blood samples to measure the effect of the study drugs on the body and voluntary genetic testing wil be taken, and any adverse events that subjects experience, as well as other medication that they are taking, will be recorded.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  10/H0717/80

• Date of REC Opinion

  27 Oct 2010

• REC opinion

  Further Information Favourable Opinion