A 4 week study to evaluate efficacy, safety and tolerability of Inhaled GRC 17536 in Patients with Refractory Chronic Cough
- Conditions
- Refractory Chronic Cough.MedDRA version: 20.0 Level: SOC Classification code 10038738 Term: Respiratory, thoracic and mediastinal disorders System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2013-002728-17-GB
- Lead Sponsor
- Glenmark Pharmaceuticals SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 52
1. Patients with refractory chronic cough are defined as: cough lasting longer than 8 weeks; and refractory after routine assessment as per British Thoracic Society (BTS) guidelines despite adequate treatment of potential aggravating factors or removal of obvious precipitating factors. Adequate treatment equals treatment at the dose and duration recommended by the BTS guidelines;
2. Males and females of non child-bearing potential (post menopausal/surgically sterile only) of =18 yrs and = 75 yrs;
3. Non-smokers or ex-smokers for at least 12 months prior to study;
4. Patients with documented normal chest X-ray or CT scan (historical data up to 1 year may be used); normal spirometry; vitals and clinical laboratory tests within the reference ranges or clinically acceptable to the investigator;
5. Patients who are able and willing to provide voluntary written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Patients with non-chronic or acute cough or cough with purulent sputum or cough with sputum >10 mL/day;
2. Patients with a cough severity threshold < 20 mm on a VAS severity scale.
3. Active respiratory disease (asthma with symptoms of dyspnoea, wheezing; COPD, bronchiectasis, bronchiolitis) or any clinically significant structural lung or bronchoalveolar disease/damage;
4. Respiratory tract infection within 1 month prior to randomisation;
5. Positive screen for hepatitis-B surface antigen (HBsAg), antibodies to the hepatitis C virus (anti-HCV) or evidence of human immunodeficiency virus (HIV) infection;
6. Patients with known history of liver disease or abnormal liver function tests at screening [ALT or direct bilirubin) > 1.5x upper limit of normal (ULN)];
7. Concomitant disease or condition that could interfere with the conduct of the study, or for which the treatment could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study, including, but not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease;
8. Patients who have had a change in medication (taken for associated cough conditions) 2 weeks preceding randomisation;
9. Current diagnosis of active epilepsy or any active seizure disorder requiring therapy with antiepileptic drug(s); or patients on anti-epileptic treatment;
10. Patients who are not willing or whose partners are not willing to use appropriate method of contraception from the time of the first dose until 3 months after the last dose of GRC 17536; or intend to donate sperm during this period; (See section 10.3.5 Contraception)
11. Patients with clinically significant or uncontrolled hepatic, gastrointestinal, cardiovascular, respiratory, neurological (other than neuropathy), psychiatric, haematological, renal, or dermatological disease, or any other medical condition, or clinically significant abnormalities in laboratory test results or ECG that according to investigator’s medical judgment could potentially affect a patient's safety or study outcome.
12. Patients who received inducers of CYP3A4 enzymes (including but not limited to the drugs listed in excluded medications) within 4 weeks prior to the first dosing;
13. Patients who donated a unit of blood (450 ml) in the 3 months prior to first dosing or who intend to donate in the 3 months after the last scheduled study visit.
14. Patients who received angiotensin-converting-enzyme (ACE) inhibitors within 3 months prior to randomisation or are on treatment;15. Patients with a supine systolic blood pressure (SBP) =160 mmHg and/or a supine diastolic blood pressure (DBP) =100 mmHg;
16. Patients with documented or suspected or current history of alcohol abuse (intake of more than 24 units of alcohol per week) or drug abuse;
17. 12-lead ECG demonstrating QTcF>450 ms at screening;
18. Patients who have received any investigational drug (including GRC 17536) in any clinical trial within 3 months prior to randomisation, or who are on extended follow-up;
19. Patients who cannot communicate reliably with the investigator; or who are unlikely to co-operate wit
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method