RhinitisPhase 2NCT01476098
A Study to Investigate the Effect of SB-705498 on Chronic Cough
A Phase 2 study testing SB-705498 in people with Rhinitis, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This study is designed to loook at the affect of oral SB-705498 on cough following an inhaled capsaicin challenge Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rhinitis
- What is being tested?
- SB-705498
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2011to Jan 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Male or female between 30 -75 (Part A) and 18-75 (Part B) years of age inclusive.
- Non-child bearing women or women of child bearing potential if they agree to use contraception as indicated by the protocol
- Non-smoker for at least 6 months with a pack history <5 pack years (Pack years = (No. of cigarettes smoked/day/20) x No. of years smoked).
- Body weight > 50 kg and body mass index (BMI) within the range 19 - 30.0 kg/m2 (inclusive).
- Capable of giving written informed consent.
- Agree to use contraception listed as acceptable
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- Normal 12-lead ECG at screening.
- Chronic cough (Part B only)
- Good general health, apart from chronic cough (part B only), as determined by a responsible physician.
Who cannot join
- A history of gastrointestinal, hepatic, renal or multiple cardiovascular risk factors.
- Positive pre-study drug/alcohol screen.
- Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- A positive test for human immunodeficiency virus (HIV) antibody (if determined by the local standard operating procedures (SOPs)).
- History of regular alcohol consumption within 6 months of the study.
- Exposure to more than four new chemical entities within 12 months prior to the start of the study.
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- Participation in a clinical trial with a new molecule entity or any other clinical trial within 30 days of the start of the study.
- Use of prescription or non-prescription drugs, as well as of vitamins, herbal and dietary supplements (including St John's Wort) within 7 days prior to study.
- known history of lung cancer
- current treatment with oral corticosteriods or other immunosupressive agents
- FEV1 less than 80% of predicted value at screening
- Any subject who does not reach C5 following 250uM oral capsaicin
- History of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation.
- Donation of blood or blood products in excess of 500mL within a 56 day period prior the start study.
- Pregnant females as determined by positive serum or urine human chorionic gonadotropin (hCG) test at screening or prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- consumption of red wine, seville oranges, grapefruit or grapefruit juice from 7 days prior to dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two Part Study to Investigate Pharmacokinetics (PK) & Pharamcodynamics (PD) of SB-705498 in Cough. Part A:Open Label Study in Healthy Subjects to Determine Exposure to SB-705498. Part B:Double-blind, Placebo Controlled, Cross Over Study to Investigate Effect of SB-705498 on Capsaicin Induced Cough and 24 Hour Cough Counts in Cough Patients
This study is designed to loook at the affect of oral SB-705498 on cough following an inhaled capsaicin challenge
- Conditions
- Rhinitis
- Being tested
- Placebo, SB-705498
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
SB-705498 placebo
SB-705498Drug
400 or 600mg oral SB-705498
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Placebo comparator | incremental doses capsaicin Receives: Drug: Placebo; Drug: SB-705498 |
| Arm 2 | Active comparator | incremenrtal doses casaicin Receives: Drug: Placebo; Drug: SB-705498 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Day -1 and Day 1 (2 and 24 hours)
Secondary outcomes (21)
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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 7
Summary of Vital Signs- Heart rate (Part B)
Heart rate was assessed on pre dose and 4 hours post dose.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01476098
- Sponsor's protocol ID
- 114693
- Status last verified
- Nov 2016
- First submitted
- 13 Oct 2011
- Last updated
- 1 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two Part Study to Investigate Pharmacokinetics (PK) & Pharamcodynamics (PD) of SB-705498 in Cough. Part A:Open Label Study in Healthy Subjects to Determine Exposure to SB-705498. Part B:Double-blind, Placebo Controlled, Cross Over Study to Investigate Effect of SB-705498 on Capsaicin Induced Cough and 24 Hour Cough Counts in Cough Patients
- ClinicalTrials.gov ID
- NCT01476098
- Acronym / sponsor ID
- 114693
- Conditions
- Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 22 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to loook at the affect of oral SB-705498 on cough following an inhaled capsaicin challenge
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Placebo comparator | Drug: Placebo, Drug: SB-705498incremental doses capsaicin |
| Arm 2 | Active comparator | Drug: Placebo, Drug: SB-705498incremenrtal doses casaicin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female between 30 -75 (Part A) and 18-75 (Part B) years of age inclusive.
- Non-child bearing women or women of child bearing potential if they agree to use contraception as indicated by the protocol
- Non-smoker for at least 6 months with a pack history <5 pack years (Pack years = (No. of cigarettes smoked/day/20) x No. of years smoked).
- Body weight > 50 kg and body mass index (BMI) within the range 19 - 30.0 kg/m2 (inclusive).
- Capable of giving written informed consent.
Key exclusion criteria (19 listed)
- A history of gastrointestinal, hepatic, renal or multiple cardiovascular risk factors.
- Positive pre-study drug/alcohol screen.
- Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- A positive test for human immunodeficiency virus (HIV) antibody (if determined by the local standard operating procedures (SOPs)).
- History of regular alcohol consumption within 6 months of the study.
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 |
|---|---|---|
| PlaceboSB-705498 placebo | Drug | Arm 1, Arm 2 |
| SB-705498400 or 600mg oral SB-705498 | Drug | Arm 1, Arm 2 |
Primary outcome
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
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 hours post-dose
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.
Maximum observed concentration (Cmax) following 10 hour sampling of a single dose of SB-705498 - Part A
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 hours post-dose Day 1
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.
Time of occurrence of Cmax (Tmax) following 10 hour sampling of a single dose of SB-705498 -Part A
Time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 hours post-dose
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.
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
Time frame: Day -1 (baseline) and Day 1 (2 hours post dose
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).
Capsaicin concentration required to achieve C5 following a single dose of SB-705498 or placebo- Part B
Time frame: Day -1, Day 1 (2hrs and 24 hrs post dose)
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).
Cough Count Per 24 hour following single dose of SB-705498 as compared to placebo- Part B
Time frame: Day -1 and Day 1 (2 and 24 hours)
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.
21 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: Day -1 and 14
Urge to cough Visual Analogue Scale (VAS) following single dose of SB-705498- Part B
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to Day 2 (Period 2)
Number participants with Adverse Events(AEs) and serious adverse events (SAEs)- Part A
Time frame: Up to Day 7
Number participants with AEs and SAEs- Part B
Time frame: up to Day 42
Summary of vital signs -systolic and diastolic blood pressure (Part A)
Time frame: Up to Day 7
Summary of vital signs -systolic and diastolic blood pressure (Part B)
Time frame: Up to Day 42
Summary of Vital Signs- Heart rate (Part A)
Time frame: Up to Day 7
Summary of Vital Signs- Heart rate (Part B)
Time frame: Up to Day 42
Summary of Vital Signs- Body temperature (Part A)
Time frame: Up to Day 7
Summary of Vital Signs- Body temperature (Part B)
Time frame: Up to Day 42
Number of participants with ECG findings- Part A
Time frame: Up to Day 7
Number of participants with ECG findings- Part B
Time frame: Up to Day 42
Number of participants with potential clinical importance (PCI) laboratory assessments- hematology Part A
Time frame: Up to 4 weeks
Number of participants with potential clinical importance (PCI) laboratory assessments- hematology Part B
Time frame: Up to 13 weeks
Number of participants with potential clinical importance (PCI) laboratory assessments- clinical biochemistry Part A
Time frame: Up to 4 weeks
Number of participants with potential clinical importance (PCI) laboratory assessments- clinical biochemistry Part B
Time frame: Up to 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SB-705498 in people with Rhinitis, run by GlaxoSmithKline at 1 site 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 19 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: finished, as of the sponsor's last update on 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 (time frame: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 10 hours post-dose). The study lists 6 primary outcomes in all. 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 1 Dec 2016.