Double-Blind Randomised Controlled Trial of Lesogaberan in Chronic Cough PatientsThis means patients will take Lesogaberan and a dummy drug (called placebo) in a random order. During the study neither the study doctor or patient will know whether they are taking Lesogaberan or placebo as the tablets will look identical.

Phase 1

• Conditions: Chronic cough; MedDRA version: 17.1Level: LLTClassification code 10066656Term: Chronic coughSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-005074-11-GB
• Lead Sponsor: niversity Hospital South Manchester NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-25
• Study Completion: 2017-08-30
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1.Provision of signed, written and dated informed consent, prior to any study specific procedures.
2.Aged above 18 years old.
3.Agreement to comply with contraception restrictions as outlined in section 8.3.4
4.BMI of 19-35 kg/m2 (inclusive)
5.Normal spirometry.
6.Chronic dry cough of at least 8 weeks duration.
7.Normal chest X-ray.
8.Patients with cough related to nasal disease, reflux and asthma will be included. These conditions will be investigated but they will still be included.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1.History of cardiac disease, clinically significant orthostatic reactions or syncope, renal disease and hepatic disease .
2.Prolonged QTcF >450ms or family history of long QT syndrome at baseline (any prolongation of QTcF during the study will be classed as an AE unless >500 or deemed clinically significant by the research physician)
3.Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG at enrolment that may interfere with the interpretation of the QTc interval changes. This includes subjects with any of the following:
•Clinically significant PR interval prolongation
•Intermittent second or third degree AV block
•Incomplete, full or intermittent bundle branch block (QRS<11ms with normal QRS and T wave morphology is acceptable if there is no evidence of left ventricular hypertrophy)
4.Abnormal T wave morphology, particularly in the protocol define primary lead
5.Any clinically significant illness, medical or surgical procedure or trauma within the 4 weeks preceding the first administration of study medication including upper respiratory tract infections.
6. Any clinically significant abnormalities in clinical chemistry, haematology results as judged by the investigator.
7. Abnormal screening clinical pathology values or other clinically significant, unexplained biochemical abnormality according to the investigator; in particular, liver function tests (LFTs) should be within normal limits at screening.
8.Systolic blood pressure below 110 mm Hg at screening.
9.Current smoker or ex-smoker with >20 pack year history, and <6 months abstinence.
10.History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class as Lesogaberan.
11.History of drug addiction and/or alcohol abuse or other circumstances which in the investigators judgement may compromise the subject’s ability to comply with the study requirements.
12.Pregnancy or breastfeeding.
13.Treatment with ACE inhibitors will be excluded. Patients taking centrally acting medications e.g. opiates, amitriptyline, gabapentin, pregabalin for the treatment of cough, will be excluded unless they are willing to stop these treatments. Patients can be included if they are willing to stop opiates for 1 week prior to baseline visit through to follow-up visit. Pregabalin, gabapentin, amitriptyline and ACEi will need to be stopped for 4 weeks prior to baseline visit and through to follow-up visit.
14.Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months of anticipated first administration of therapy in this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified