GRC 4039-204, Version 3, 2011-04-07

• Research type

  Research Study

• Full title

  A phase II, 12-week randomized, double-blind, triple dummy, parallel group, placebo-controlled, dose range finding study to evaluate safety, tolerability and efficacy of revamilast in patients with chronic persistent asthma.

• IRAS ID

  81315

• Sponsor organisation

  Glenmark Pharmaceuticals SA

• Eudract number

  2011-000270-57

• Research summary

  Study title: A Phase II, 12-week randomized, double-blind, triple dummy, parallel group, placebo-controlled, dose range finding study to evaluate safety, tolerability and efficacy of revamilast in patients with chronic persistent asthma.Revamilast is an orally active, potent and selective phosphodiesterase 4 inhibitor being developed as a potential treatment for asthma for reducing signs and symptoms, inhibiting underlying inflammation in the bronchial airways and thereby, improving the lung function. This new drug which is being developed by Glenmark Pharmaceuticals SA, a pharmaceutical company with its headquarters based in India.The main purposes of this study are to help answer the following research questions:?½ To investigate/ evaluate effects of revamilast on lung function in patients with chronic persistent asthma?½ To evaluate the safety and tolerability of revamilast in patients with chronic persistent asthma?½ How much revamilast should be given to subjects with chronic persistent asthma (best dose finding).?½ To evaluate effect of revamilast on pharmacodynamic parameters in blood.About 448 people will take part in this study at approximately 40 centres. This study will be conducted in India, United Kingdom, Czech Republic, Poland and Russia.The study requires two groups of patients:?½ Those who are on inhaled corticosteroid (ICS) and inhaled short acting bronchodilator (Salbutamol)?½ Those who are on inhaled short acting bronchodilator (Salbutamol) (non ICS) only. Patients belonging to ICS group requires to complete 8 scheduled visits and patients from non ICS group will complete 7 scheduled visits, to the investigator site/ clinic. The participation in this study could last for 16 ?? 18 weeks depending on the group the patient belongs to.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  11/NW/0342

• Date of REC Opinion

  31 Aug 2011

• REC opinion

  Further Information Favourable Opinion