CoughPhase 1/2NCT03372603
A Study to Assess the Effectiveness and Side Effects of GSK2798745 in Participants With Chronic Cough
A Phase 1/2 study testing GSK2798745 in people with Cough, run by GlaxoSmithKline at 8 sites in United Kingdom.
Trial summary
GSK2798745 is a potent and selective transient receptor potential vanilloid 4 (TRPV4) channel blocker being investigated for the treatment of chronic cough. This is a multi-center, randomized, placebo-controlled, double-blind, two-period crossover study with a purpose to evaluate efficacy and safety of GSK2798745. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cough
- What is being tested?
- GSK2798745
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- 5 Apr 2018to 8 Oct 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years of age inclusive, at the time of signing the informed consent.
- 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.
- No significant findings on chest imaging (chest X-ray [CXR] or Computed tomography scan) within 12 months before screening (subjects with an abnormal CXR within 12 months, from a temporary process, will be allowed to participate if a repeat CXR is normal).
- Forced expiratory volume in one second (FEV1) >=80% of the predicted normal value (at screening), or documented evidence of FEV1 >=80% within the 6 months before screening.
- Score of >=40 millimeters (mm) on the Cough Severity Visual Analogue Scale (VAS) at Screening.
- Body weight >=50 kilogram (kg) and body mass index (BMI) within the range 18 to 40 kilogram per meter square (kg/m^2) (inclusive) at screening.
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- A male participant must agree to follow the contraception requirements stated 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.
- A female participant is eligible to participate if she is not of childbearing potential.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- 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 subject unsuitable for inclusion in this study.
- History or current evidence of chronic productive cough.
- History of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the 6 months before screening.
- Active ulcer disease or gastrointestinal bleeding at the time of screening (positive fecal occult blood test [FOBT] at screening).
- History of stroke or seizure disorder within 5 years of screening.
- Respiratory tract infection within 6 weeks of screening.
Show all 24Show fewer
- Subject who, in the investigator's opinion, poses a significant suicide risk. Evidence of serious suicide risk may include any history of suicidal behavior 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).
- Alanine transferase (ALT) > twice the upper limit of normal (ULN) at screening.
- Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%) at screening.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- QT interval corrected (QTc) >450 milliseconds (msec) or QTc >480 msec in subjects with bundle branch block at screening.
- Use of a listed prohibited medication within the restricted timeframe relative to the first dose of study treatment.
- Use of a strong inhibitors or inducers of cytochrome P450 (CYP) 3A or pglycoprotein.
- Participation in the study would result in loss of blood or blood products in excess of 500 milliliters (mL) within 3 months of screening.
- Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
- Current enrollment or past participation within the 3 months before screening in any clinical study involving an investigational study treatment or any other type of medical research.
- Positive human immunodeficiency virus (HIV) antibody test at screening.
- Presence of Hepatitis B surface antigen (HBsAg) at screening.
- Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study treatment.
- Positive Hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study treatment.
- Cardiac troponin at screening > ULN for the assay.
- History of alcohol abuse within 6 months of screening, in the opinion of the investigator.
- Current smoker or history of smoking within the 6 months before screening, or a cumulative history of >= 20 pack years. Pack years = (Number of cigarettes smoked/day/20) x (Number of years smoked)
- Sensitivity to any of the study treatments, or components thereof, or drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates participation in the study.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
GSK Investigational Site
Belfast, BT9 7BL
GSK Investigational Site
Belfast, BT9 7B
GSK Investigational Site
Cottingham, HU16 5JQ
GSK Investigational Site
Cottingham, HU16 5
GSK Investigational Site
Manchester, Lancashire, M23 9LT
GSK Investigational Site
Manchester, Lancashire, M23 9L
GSK Investigational Site
North Shields, NE29 8NH
GSK Investigational Site
North Shields, NE29 8
About this study
Official title: A Placebo-controlled, Double-blind (Sponsor Open), Randomized, Crossover Study to Assess the Efficacy, Safety, and Tolerability of GSK2798745 in Participants With Chronic Cough
GSK2798745 is a potent and selective transient receptor potential vanilloid 4 (TRPV4) channel blocker being investigated for the treatment of chronic cough. This is a multi-center, randomized, placebo-controlled, double-blind, two-period crossover study with a purpose to evaluate efficacy and safety of GSK2798745. Each subject will have 2 treatment periods, and will be randomized to one of the following treatments in each period: A) Placebo matching to GSK2798745 once daily for 7 days. B) 4.8 milligrams (mg) GSK2798745 on Day 1, followed by 2.4 mg GSK2798745 once daily for 6 days. There will be a washout period of 14 to 21 days between the treatment periods. A maximum of 48 subjects will be enrolled in the study and the total duration of participation in the study will be maximum of 10 and a half weeks including follow-up visit.
- Conditions
- Cough
- Being tested
- GSK2798745, Placebo
- Keywords
- GSK2798745, efficacy, safety, chronic cough, crossover study
- Medical subject headings
- Cough, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2798745Drug
GSK2798745 tablets will be available as white to almost white, round, film-coated tablets (micronized active pharmaceutical ingredient [API]) to be taken with a glass of water (approximately 240 mL).
PlaceboDrug
Placebo tablets will be available as white to almost white, round, film-coated tablets to be taken with a glass of water (approximately 240 mL).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence AB | Experimental | Subjects will receive GSK2798745 matching placebo tablets (two tablets on Day 1 followed by one tablet once daily for 6 days), via oral route (treatment period of total 7 days). After a washout period of 14 to 21 days, subjects will then receive 4.8 mg (two tablets of 2.4 mg) GSK2798745 on Day 1, followed by 2.4 mg GSK2798745 tablets once daily for 6 days via oral route (treatment period of total 7 days). Receives: Drug: GSK2798745; Drug: Placebo |
| Treatment Sequence BA | Experimental | Subjects will receive 4.8 mg (two tablets of 2.4 mg) GSK2798745 on Day 1, followed by 2.4 mg GSK2798745 tablets once daily for 6 days via oral route (treatment period of total 7 days). After a washout period of 14 to 21 days, subjects will then receive GSK2798745 matching placebo tablets (two tablets on Day 1 followed by one tablet once daily for 6 days), via oral route (treatment period of total 7 days). Receives: Drug: GSK2798745; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Cough Counts During Day Time Hours Following 7-days of Dosing
Coughs were monitored using the VitaloJAK cough monitor. The total cough counts during day-time (10 hours) was calculated from the time of the monitor being attached i.e. immediately after dosing on Day 7 to 10 hours past the time of monitoring. Total cough counts were log-transformed prior to analysis. A non-informative prior was used. Analysis was performed using a Bayesian mixed model adjusting for subject-level and period-adjusted baselines, treatment and period. Subject-level baseline is defined as the mean of the two period-specific baselines. Period-adjusted baseline is defined as the difference between the period-specific baseline and subject-level baseline for each period. Posterior median and 95% credible interval is reported. All Subjects Population included all randomized participants who took at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.
Measured: Up to 10 hours post-dose on Day 7 of each treatment period
Secondary outcomes (18)
Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment.
Measured: Up to 45 days
Change From Baseline Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Amino Transferase (AST) and Creatinine Kinase (CK)
Blood samples were collected for the analysis of clinical chemistry parameters including ALP, ALT, AST and CK. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and Day 8 of each treatment period
Change From Baseline Values for Clinical Chemistry Parameter: Direct Bilirubin, Total Bilirubin and Creatinine
Blood samples were collected for the analysis of clinical chemistry parameters including direct bilirubin, total bilirubin and creatinine. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and Day 8 for each treatment period
Change From Baseline Values for Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Urea
Blood samples were collected for the analysis of clinical chemistry parameters including calcium, glucose, potassium, sodium and urea/blood urea nitrogen (BUN). Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and Day 8 of each treatment period
Change From Baseline Values for Clinical Chemistry Parameter: Total Protein
Blood samples were collected for the analysis of clinical chemistry parameter total protein. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and Day 8 of each treatment period
Number of Participants With Abnormal Values of Cardiac Troponin
Cardiac troponin values was measured in participants.
Measured: Up to 45 days
Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell (WBC) Count
Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, lymphocytes, monocytes, total neutrophils, platelet count and WBC count. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and Day 8 of each treatment period
Change From Baseline Values for Hematology Parameter: Hemoglobin
Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and Day 8 for each treatment period
Change From Baseline Values for Hematology Parameter: Hematocrit
Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and Day 8 of each treatment period
Change From Baseline Values for Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Blood samples were collected for the analysis of hematology parameter: MCH. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and Day 8 for each treatment period
Change From Baseline Values for Hematology Parameter: Mean Corpuscular Volume (MCV)
Blood samples were collected for the analysis of hematology parameter: MCV. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and Day 8 of each treatment period
Change From Baseline Values for Hematology Parameter: Red Blood Cell (RBC) Count
Blood samples were collected for the analysis of hematology parameter: RBC count. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and Day 8 for each treatment period
Change From Baseline Values for Hematology Parameter: Reticulocytes
Blood samples were collected for the analysis of hematology parameter: reticulocytes. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (Day -1) and Day 8 for each treatment period
Number of Participants With Abnormal Urinalysis Data
Urine samples were collected for analysis of urinalysis data by dipstick method. Number of participants with abnormal urinalysis data has been presented. Abnormality was defined as value of potential clinical importance (PCI). PCI was flagged when a result changed from negative on Day 1 (pre-dose) to positive on Day 8.
Measured: Up to Day 8
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Blood pressure was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (pre-dose on Day 1) and Day 8 of each treatment period
Change From Baseline in Temperature
Temperature was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (pre-dose on Day 1) and Day 8 of each treatment period
Change From Baseline in Heart Rate
Heart rate was measured at indicated time points in supine position after 5 minutes rest for the participant. Baseline was defined as latest pre-dose assessment with a non-missing value in each treatment period. Change from Baseline was calculated as the value at the post-dose visit minus the Baseline value.
Measured: Baseline (pre-dose on Day 1) and Day 8 of each treatment period
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Twelve-lead ECG was obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and corrected QT (QTc) intervals. Number of participants with abnormal-clinically significant and abnormal-not clinically significant values has been presented.
Measured: Baseline (pre-dose on Day 1) and Day 8 of each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start5 Apr 2018
- Primary completion8 Oct 2018
- Study completion8 Oct 2018
Why it stopped: Study terminated due to lack of efficacy of GSK2798745 in chronic cough.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a multi-center, randomized, placebo-controlled, double-blind, two-period crossover study. Each subject will be screened (screening may be conducted across more than 1 visit); each subject will have 2 treatment periods (each 7 days) with a washout period of 14 to 21 days between the treatment periods; and each subject will have a follow-up visit (within 7 to 10 days after their last dose). Each subject will be involved in the study for a maximum of 10 and a half weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKlineGSK Clinical Trials, Study director, GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372603
- Sponsor's protocol ID
- 207702
- Other IDs
- 2017-002265-21, 2017
- Status last verified
- Aug 2019
- First submitted
- 8 Dec 2017
- Last updated
- 2 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled, Double-blind (Sponsor Open), Randomized, Crossover Study to Assess the Efficacy, Safety, and Tolerability of GSK2798745 in Participants With Chronic Cough
- ClinicalTrials.gov ID
- NCT03372603
- Acronym / sponsor ID
- 207702
- Conditions
- Cough
- Keywords
- GSK2798745, efficacy, safety, chronic cough, crossover study
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated due to lack of efficacy of GSK2798745 in chronic cough.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 8 Oct 2018 (actual)
- Study completion
- 8 Oct 2018 (actual)
- First posted
- 13 Dec 2017 (actual)
- Results
- Posted 2 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
GSK2798745 is a potent and selective transient receptor potential vanilloid 4 (TRPV4) channel blocker being investigated for the treatment of chronic cough. This is a multi-center, randomized, placebo-controlled, double-blind, two-period crossover study with a purpose to evaluate efficacy and safety of GSK2798745. Each subject will have 2 treatment periods, and will be randomized to one of the following treatments in each period: A) Placebo matching to GSK2798745 once daily for 7 days. B) 4.8 milligrams (mg) GSK2798745 on Day 1, followed by 2.4 mg GSK2798745 once daily for 6 days. There will be a washout period of 14 to 21 days between the treatment periods. A maximum of 48 subjects will be enrolled in the study and the total duration of participation in the study will be maximum of 10 and a half weeks including follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a multi-center, randomized, placebo-controlled, double-blind, two-period crossover study. Each subject will be screened (screening may be conducted across more than 1 visit); each subject will have 2 treatment periods (each 7 days) with a washout period of 14 to 21 days between the treatment periods; and each subject will have a follow-up visit (within 7 to 10 days after their last dose). Each subject will be involved in the study for a maximum of 10 and a half weeks.
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence AB | Experimental | Drug: GSK2798745, Drug: PlaceboSubjects will receive GSK2798745 matching placebo tablets (two tablets on Day 1 followed by one tablet once daily for 6 days), via oral route (treatment period of total 7 days). After a washout period of 14 to 21 days, subjects will then receive 4.8 mg (two tablets of 2.4 mg) GSK2798745 on Day 1, followed by 2.4 mg GSK2798745 tablets once daily for 6 days via oral route (treatment period of total 7 days). |
| Treatment Sequence BA | Experimental | Drug: GSK2798745, Drug: PlaceboSubjects will receive 4.8 mg (two tablets of 2.4 mg) GSK2798745 on Day 1, followed by 2.4 mg GSK2798745 tablets once daily for 6 days via oral route (treatment period of total 7 days). After a washout period of 14 to 21 days, subjects will then receive GSK2798745 matching placebo tablets (two tablets on Day 1 followed by one tablet once daily for 6 days), via oral route (treatment period of total 7 days). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age between 18 and 75 years of age inclusive, at the time of signing the informed consent.
- 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.
- No significant findings on chest imaging (chest X-ray [CXR] or Computed tomography scan) within 12 months before screening (subjects with an abnormal CXR within 12 months, from a temporary process, will be allowed to participate if a repeat CXR is normal).
- Forced expiratory volume in one second (FEV1) >=80% of the predicted normal value (at screening), or documented evidence of FEV1 >=80% within the 6 months before screening.
- Score of >=40 millimeters (mm) on the Cough Severity Visual Analogue Scale (VAS) at Screening.
Key exclusion criteria (24 listed)
- 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 subject unsuitable for inclusion in this study.
- History or current evidence of chronic productive cough.
- History of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the 6 months before screening.
- Active ulcer disease or gastrointestinal bleeding at the time of screening (positive fecal occult blood test [FOBT] at screening).
- History of stroke or seizure disorder within 5 years of screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GSK2798745GSK2798745 tablets will be available as white to almost white, round, film-coated tablets (micronized active pharmaceutical ingredient [API]) to be taken with a glass of water (approximately 240 mL). | Drug | Treatment Sequence AB, Treatment Sequence BA |
| PlaceboPlacebo tablets will be available as white to almost white, round, film-coated tablets to be taken with a glass of water (approximately 240 mL). | Drug | Treatment Sequence AB, Treatment Sequence BA |
Primary outcome
Total Cough Counts During Day Time Hours Following 7-days of Dosing
Time frame: Up to 10 hours post-dose on Day 7 of each treatment period
Coughs were monitored using the VitaloJAK cough monitor. The total cough counts during day-time (10 hours) was calculated from the time of the monitor being attached i.e. immediately after dosing on Day 7 to 10 hours past the time of monitoring. Total cough counts were log-transformed prior to analysis. A non-informative prior was used. Analysis was performed using a Bayesian mixed model adjusting for subject-level and period-adjusted baselines, treatment and period. Subject-level baseline is defined as the mean of the two period-specific baselines. Period-adjusted baseline is defined as the difference between the period-specific baseline and subject-level baseline for each period. Posterior median and 95% credible interval is reported. All Subjects Population included all randomized participants who took at least 1 dose of study treatment. Participants were analyzed according to the treatment they actually received.
18 secondary outcomes
Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 45 days
Change From Baseline Values for Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Amino Transferase (AST) and Creatinine Kinase (CK)
Time frame: Baseline (Day -1) and Day 8 of each treatment period
Change From Baseline Values for Clinical Chemistry Parameter: Direct Bilirubin, Total Bilirubin and Creatinine
Time frame: Baseline (Day -1) and Day 8 for each treatment period
Change From Baseline Values for Clinical Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Urea
Time frame: Baseline (Day -1) and Day 8 of each treatment period
Change From Baseline Values for Clinical Chemistry Parameter: Total Protein
Time frame: Baseline (Day -1) and Day 8 of each treatment period
Number of Participants With Abnormal Values of Cardiac Troponin
Time frame: Up to 45 days
Change From Baseline Values for Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils, Platelet Count and White Blood Cell (WBC) Count
Time frame: Baseline (Day -1) and Day 8 of each treatment period
Change From Baseline Values for Hematology Parameter: Hemoglobin
Time frame: Baseline (Day -1) and Day 8 for each treatment period
Change From Baseline Values for Hematology Parameter: Hematocrit
Time frame: Baseline (Day -1) and Day 8 of each treatment period
Change From Baseline Values for Hematology Parameter: Mean Corpuscular Hemoglobin (MCH)
Time frame: Baseline (Day -1) and Day 8 for each treatment period
Change From Baseline Values for Hematology Parameter: Mean Corpuscular Volume (MCV)
Time frame: Baseline (Day -1) and Day 8 of each treatment period
Change From Baseline Values for Hematology Parameter: Red Blood Cell (RBC) Count
Time frame: Baseline (Day -1) and Day 8 for each treatment period
Change From Baseline Values for Hematology Parameter: Reticulocytes
Time frame: Baseline (Day -1) and Day 8 for each treatment period
Number of Participants With Abnormal Urinalysis Data
Time frame: Up to Day 8
Change From Baseline in Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Time frame: Baseline (pre-dose on Day 1) and Day 8 of each treatment period
Change From Baseline in Temperature
Time frame: Baseline (pre-dose on Day 1) and Day 8 of each treatment period
Change From Baseline in Heart Rate
Time frame: Baseline (pre-dose on Day 1) and Day 8 of each treatment period
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Time frame: Baseline (pre-dose on Day 1) and Day 8 of each treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
GSK Clinical Trials study director
GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GSK2798745 in people with Cough, run by GlaxoSmithKline at 8 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Cough Counts During Day Time Hours Following 7-days of Dosing (time frame: Up to 10 hours post-dose on Day 7 of each treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2019.