A 4 Week Treatment Period for Patients with Refractory Chronic Cough
Research type
Research Study
Full title
A Phase 2a, 4-Week Treatment Period, Randomized, Double-Blind, Parallel Group, PA Phase 2a, 4-Week Treatment Period, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Proof of Concept Study to Evaluate Efficacy, Safety and Tolerability of Inhaled GRC 17536 in Patients with Refractory Chronic Cough
IRAS ID
136437
Contact name
Surinder Birring
Contact email
Sponsor organisation
Glenmark Pharmaceuticals S A
Eudract number
2013-002728-17
Research summary
GRC 17536 is a drug that may be useful in the treatment of inflammatory (a localised protective reaction of tissue to irritation, injury, or infection) lung conditions such as refractory chronic cough (cough that that lasts longer than 8 weeks and does not respond to treatment). \n\nNerve cells have special proteins, which can sense irritant stimuli. When these special proteins are activated, the nerve cells release a variety of mediators (helpers), which promote inflammation and initiate a cough reflex. GRC 17536 is a chemical which, blocks one of these special proteins on nerve cells and therefore has the potential to reduce airway inflammation and cough. \n\nThe purpose of this study is to help answer the following question(s): \n• Does taking GRC 17536 help someone with a chronic cough?\n• Does GRC 17536 have a good safety profile? \n• How does GRC 17536 compare to placebo?\n\nApproximately 48 patients with refractory chronic cough will be enrolled at 7 clinics in the UK. Patient participation in the study will last for a maximum of 8 weeks. There will be 6 visits that include the screening visit (Day –14 to Day -1) followed by 4 interim visits (Days 0, 1, 14 and 28) and a follow up visit (Day 42). GRC 17536 or placebo will be administered by oro-inhalation twice daily from Day 1 to Day 28.\n\nDuring the study, effectiveness of the study drug will be assessed by measuring 24 hr cough count (via a digital ambulatory cough monitor) and patient questionnaires. The safety profile of the drug will be assessed by evaluating adverse events and by performing routine laboratory tests. Blood sample will be collected in a subset of ~10-12 patients to measure the plasma level of GRC 17536; and for genetic testing (for which separate consent will be obtained).
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
13/EE/0247
Date of REC Opinion
16 Sep 2013
REC opinion
Further Information Favourable Opinion