Chronic cough MedDRA version: 20.0 Level: LLT Classification code 10066656 Term: Chronic cough System Organ Class: 100000004855
Conditions
Interventions
Product Name: GSK2798745
Product Code: GSK2798745
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Not Applicable
CAS Number
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: AGE 1.Between 18 and 75 years of age inclusive, at the time of signing the informed consent. TYPE OF PARTICIPANT AND DISEASE CHARACTERISTICS 2.Chronic idiopathic cough for =1 year (before screening), defined as: •a cough that is unresponsive to at least 8 weeks of targeted treatment, or •a cough for which no objective evidence of an underlying trigger has been determined, despite medical investigations. 3.No significant findings on chest imaging (CXR or CT scan) within 12 months before screening (participants with an abnormal CXR within 12 months, from a temporary process, will be allowed to participate if a repeat CXR is normal). 4.FEV1 =80% and =120% of the predicted normal value (at screening), or documented evidence of FEV1 =80% and =120% within the 6 months before screening. 5.Score of =40 mm on the Cough Severity VAS at Screening. WEIGHT 6.Body weight =50 kg and body mass index (BMI) within the range 18 to 32 kg/m2 (inclusive) at screening. SEX 7.Male or female a.Male participants: A male participant must agree to use contraception as detailed in the protocol from the time of first dose of study treatment until 2 weeks after last dose of study treatment, and refrain from donating sperm during this period. b.Female participants: A female participant is eligible to participate if she is not of childbearing potential as defined in the protocol. INFORMED CONSENT 8.Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: MEDICAL CONDITIONS 1.History or current evidence of any serious or clinically significant gastrointestinal, renal, endocrine, neurologic, hematologic or other condition that is uncontrolled on permitted therapies or that would, in the opinion of the investigator or the medical monitor, make the participant unsuitable for inclusion in this study. 2.History or current evidence of chronic productive cough. 3.History of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the 6 months before screening. 4.Active ulcer disease or gastrointestinal bleeding at the time of screening (positive fecal occult blood test [FOBT] at screening). 5.History of stroke or seizure disorder within 5 years of screening. 6.Respiratory tract infection within 6 weeks of screening. 7.Participant who, in the investigator’s opinion, poses a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behaviour and/or any evidence of suicidal ideation on any questionnaires e.g. Type 4 or 5 on the Columbia Suicidality Severity Rating Scale (C-SSRS) in the last 6 months (assessed at screening). 8.Alanine transferase (ALT) >2x upper limit of normal (ULN) at screening. 9.Bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin 450 msec or QTc >480 msec in participants with bundle branch block at screening. NOTE: The QTc is the QT interval corrected for heart rate according to Bazett’s formula (QTcB), Fridericia’s formula (QTcF), and/or another method. It is either machine-read or manually over-read. Refer protocol for other enclosed points on exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: •To compare the efficacy of 7 days dosing of GSK2798745 with placebo in participants with idiopathic or treatment-resistant chronic cough;Secondary Objective: •To compare the safety of GSK2798745 with placebo in participants with idiopathic or treatment-resistant chronic cough;Primary end point(s): •Total cough counts during day-time hours following 7 days of dosing;Timepoint(s) of evaluation of this end point: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Adverse events (AE), clinical laboratory values, vital signs, electrocardiogram (ECG), and other safety biomarkers;Timepoint(s) of evaluation of this end point: Throughout the duration of the study | — |
Countries
United Kingdom
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research and Development Ltd
Outcome results
None listed