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This study is designed to loook at the affect of oral SB-705498 on cough following an inhaled capsaicin challenge
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Placebo Comparator | incremental doses capsaicin |
|
| Arm 2 | Active Comparator | incremenrtal doses casaicin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | SB-705498 placebo |
| |
| SB-705498 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter of area under the plasma concentration-time curve from time zero to 4 hours AUC(0-4) and from time zero (pre-dose) to last time of quantifiable concentration AUC(0-t)- Part A | AUC(0-4) is a measure of the average amount of study drug in the blood plasma over a period of 4 hours after the dose and AUC(0-t) is a measure average amount of study drug in the blood plasma over a period of last time of quantifiable concentration. Both the parameters were calculated by standard non-compartmental analysis. Blood samples for PK analysis were obtained at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 hours post-dose. | pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 hours post-dose |
| Maximum observed concentration (Cmax) following 10 hour sampling of a single dose of SB-705498 - Part A | Cmax is defined as the maximum or "peak" concentration of a drug observed after its administration. Cmax is one of the parameters of particular use in estimating the bioavailability of drugs, by measuring the total amount of drug absorbed. It was calculated by standard non-compartmental analysis. Blood samples for PK analysis were obtained at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 hours post-dose. | pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 hours post-dose Day 1 |
| Time of occurrence of Cmax (Tmax) following 10 hour sampling of a single dose of SB-705498 -Part A | Tmax is defined as the time of occurrence of Cmax. Blood samples for PK analysis were obtained at pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 hours post-dose. | pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 hours post-dose |
| Capsaicin concentration required to achieve Five or more coughs (C5) following a single dose of SB-705498 at Tmax as compared to baseline- Part A | The concentration of capsaicin required to elicit 5 coughs was analyzed. The distributional properties were investigated, and the endpoint was logged (base 2) for analysis and the difference from Day -1 (baseline) was taken (equivalent to ratio on log scale). |
| Measure | Description | Time Frame |
|---|---|---|
| Capsaicin concentration required to achieve two or more coughs (C2) following a single dose of SB-705498 at Tmax as compared to baseline- Part A | The concentration of capsaicin required to elicit 2 coughs was analyzed. The distributional properties were investigated, and the endpoint was logged (base 2) for analysis and the difference from Day -1 (baseline) was taken (equivalent to ratio on log scale). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Manchester | M23 9QZ | United Kingdom |
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| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 114693 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 26, 2017 | |
| Reset | Mar 16, 2017 | |
| Release | Mar 27, 2017 | |
| Reset | May 4, 2017 | |
| Release | Nov 29, 2017 | |
| Unrelease | Aug 15, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 26, 2017 | Mar 16, 2017 | |||
| Mar 27, 2017 |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C512301 | SB 705498 |
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| Drug |
400 or 600mg oral SB-705498 |
|
| Day -1 (baseline) and Day 1 (2 hours post dose |
| Capsaicin concentration required to achieve C5 following a single dose of SB-705498 or placebo- Part B | The concentration of capsaicin required to elicit 5 coughs was analyzed. The distributional properties were investigated, and the endpoint was logged (base 2) for analysis and the difference from Day -1 (baseline) was taken (equivalent to ratio on log scale). | Day -1, Day 1 (2hrs and 24 hrs post dose) |
| Cough Count Per 24 hour following single dose of SB-705498 as compared to placebo- Part B | 24 hour cough count (rate/h) following single dose of SB-705498 as compared to placebo were analyzed by first log transforming the cough counts taken on Day -1 and on Day 1 of each period in the 24 hours post dose. The cough count rates were log(10) transformed. | Day -1 and Day 1 (2 and 24 hours) |
| Day -1 and Day 1 (2 hours post dose) |
| Capsaicin concentration required to achieve C2 following a single dose of SB-705498 at Tmax as compared to baseline- Part B | Day 1 (2 and 24 hours post dose) |
| Changes in the Cough Quality of Life Questionnaire (CQLQ) following a single dose of SB-705498 compared to placebo- Part B | It is a validated, 28-item assessment tool designed to evaluate decrements in quality of life due to chronic cough. This questionnaire measures cough-related symptoms, as well as the social implications and psychological impact. Examples of items include, "I cannot sleep at night" and "I cough and it makes me retch." The final score is obtained by summing the responses to 28 questions, each scored on a 1-4 scale, where 1 is "strongly disagree," and 4 is "strongly agree." The minimum and maximum CQLQ scores are 28 and 112 respectively, with increasing score indicating more severe impairment. | Day -1 and 14 |
| Urge to cough Visual Analogue Scale (VAS) following single dose of SB-705498- Part B | VAS following single dose of SB-705498 was summarized on Day -1, and Day 1 pre-dose, 2 and 24 hours. | Day -1 and Day 1 (pre-dose 2 and 24 hours) |
| Capsaicin concentration required to achieve C5 following a single dose of SB-705498 at 24 hours as compared to baseline-Part B | The concentration of capsaicin required to elicit 5 coughs was analyzed. The distributional properties were investigated, and the endpoint was logged (base 2) for analysis and the difference from Day -1 (baseline) was taken (equivalent to ratio on log scale). | Day -1 and Day 1 (2 and 24 hours post dose) |
| Capsaicin concentration required to achieve C2 following a single dose of SB-705498 at 24 hours as compared to baseline- Part B | The concentration of capsaicin required to elicit 2 coughs was analyzed. The distributional properties were investigated, and the endpoint was logged (base 2) for analysis and the difference from Day -1 (baseline) was taken (equivalent to ratio on log scale). | Day -1 and Day 1 (2 and 24 hours post dose) |
| The 24-hour cough count (rate) subdivided by day and night cough counts (rates) to give day/night specific values by treatment group-Part B | Different cough intervals were investigated, such as a day and night time rate. Participants were treated as a random effect in the model. The mean treatment difference and associated 95% confidence interval was back-transformed to provide a treatment ratio and 95% confidence interval for the ratio. | Up to Day 2 (Period 2) |
| Number participants with Adverse Events(AEs) and serious adverse events (SAEs)- Part A | An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. | Up to Day 7 |
| Number participants with AEs and SAEs- Part B | An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. | up to Day 42 |
| Summary of vital signs -systolic and diastolic blood pressure (Part A) | Systolic and diastolic blood pressure was assessed on pre dose and 2, 10 hours post dose. | Up to Day 7 |
| Summary of vital signs -systolic and diastolic blood pressure (Part B) | Systolic and diastolic blood pressure was assessed on pre dose and 4 hours post dose. | Up to Day 42 |
| Summary of Vital Signs- Heart rate (Part A) | Heart rate was assessed on pre dose and 2, 10 hours post dose. | Up to Day 7 |
| Summary of Vital Signs- Heart rate (Part B) | Heart rate was assessed on pre dose and 4 hours post dose. | Up to Day 42 |
| Summary of Vital Signs- Body temperature (Part A) | Body temperature was measured with a tympanic thermometer at pre-dose, 1, 2, 4, 10 hours post dose. | Up to Day 7 |
| Summary of Vital Signs- Body temperature (Part B) | Body temperature was measured with a tympanic thermometer at pre-dose, 1, 2, 4, 24 hours post dose. | Up to Day 42 |
| Number of participants with ECG findings- Part A | Single 12-lead ECGs was obtained at each time point during the study using an ECG machine. Participants with abnormal values have been presented. | Up to Day 7 |
| Number of participants with ECG findings- Part B | Single 12-lead ECGs was obtained at each time point during the study using an ECG machine. Participants with abnormal values have been presented. | Up to Day 42 |
| Number of participants with potential clinical importance (PCI) laboratory assessments- hematology Part A | Hematology PCI values were: White Blood Cell Count; 0.67 (low) and 1.82 (high), Neutrophil Count; 0.83 (low), Hemoglobin (male); 1.03 (high), Hemoglobin (female); 1.13 (high), Hematocrit (male); 1.02 (high), Hematocrit (female); 1.17(high), Platelet Count; 0.67 and 1.57 (high), Lymphocytes; 0.81 (low). | Up to 4 weeks |
| Number of participants with potential clinical importance (PCI) laboratory assessments- hematology Part B | Hematology PCI values were: White Blood Cell Count; 0.67 (low) and 1.82 (high), Neutrophil Count; 0.83 (low), Hemoglobin (male); 1.03 (high), Hemoglobin (female); 1.13 (high), Hematocrit (male); 1.02 (high), Hematocrit (female); 1.17(high), Platelet Count; 0.67 and 1.57 (high), Lymphocytes; 0.81 (low). | Up to 13 weeks |
| Number of participants with potential clinical importance (PCI) laboratory assessments- clinical biochemistry Part A | Clinical biochemistry PCI values were: Albumin; 0.86 (low), Calcium; 0.91(low) and 1.06 (high), Glucose; 0.71 (low) and 1.41 (high), Potassium; 0.86 (low) and 1.10 (high), Sodium; 0.96(low) and 1.03(high). | Up to 4 weeks |
| Number of participants with potential clinical importance (PCI) laboratory assessments- clinical biochemistry Part B | Clinical biochemistry PCI values were: Albumin; 0.86 (low), Calcium; 0.91(low) and 1.06 (high), Glucose; 0.71 (low) and 1.41 (high), Potassium; 0.86 (low) and 1.10 (high), Sodium; 0.96(low) and 1.03(high). | Up to 13 weeks |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114693 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114693 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114693 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114693 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114693 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114693 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| May 4, 2017 |
| Nov 29, 2017 | Aug 15, 2018 |
| D010038 |
| Otorhinolaryngologic Diseases |