RhinitisPhase 1NCT00731250
A Study To Assess The Effect Of SB-705498 In A Capsaicin Challenge Model
A Phase 1 study testing SB-705498 and Caspaicin in people with Rhinitis, run by GlaxoSmithKline at 1 site in Netherlands.
Trial summary
This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by capsaicin challenge Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinitis
- What is being tested?
- SB-705498 and Caspaicin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Jul 2008to 31 Mar 2009
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy.
- Male or female between 18 and 60 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 - 29.9 kg/m2 (inclusive).
- Capable of giving written informed consent.
Show all 9Show fewer
- Available to complete all the required study measurements.
- Normal 12-lead ECG at screening.
- For Part 2 only: The subject must demonstrate reactivity to unilateral, intranasal challenge with the selected single dose of capsaicin, defined as development of TSS ≥ 3.
Who cannot join
- Past medical history of rhinitis, including allergic, non-allergic rhinitis and rhinosinusitis.
- Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, other nasal malformations.
- 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)).
Show all 20Show fewer
- 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.
- Participation in a clinical trial with a new molecule entity or any other clinical trial within 4 months 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 2 days prior to each study visit in Part 1 of the study or 14 days prior to the first treatment administration in Part 2 of the study.
- Inability to abstain from all intranasal or oral medication to treat nasal symptoms from the first capsaicin challenge to the completion of the study including: sodium cromoglycate, antihistamines, anticholinergics, alpha-adrenergic agonists and corticosteroids
- History of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation.
- Subjects demonstrating hypersensitivity to the placebo capsaicin challenge at baseline screening.
- Donation of blood or blood products in excess of 500mL within a 56 day period prior the start of Part 2 of this 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.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Nicotine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- For Part 2 only: Subjects with known lactose intolerance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled Study to Assess the Effect of Oral, Single Dose SB-705498 in a Validated Intranasal Capsaicin Challenge Model in Healthy Volunteers
This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by capsaicin challenge
- Conditions
- Rhinitis
- Being tested
- SB-705498, Placebo, Caspaicin
- Keywords
- Capsaicin challenge
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-705498Drug
Subjects will be administered a single dose of 400 mg SB-705498
PlaceboDrug
Subjects will be administered SB-705498 matching placebo tablets
CaspaicinOther
Subjects will be challenged with 0.5 µg, 5.0 µg and 50 µg intranasal dose
| Study group | Role | What they receive |
|---|---|---|
| PART 1-Visit 1-Placebo | Placebo comparator | Eligible subjects will receive matching placebo tablets Receives: Drug: Placebo |
| PART 1-Visit 1-Capsaicin | Experimental | Eligible subjects will receive incremental capsaicin doses Receives: Other: Caspaicin |
| PART 1-Visit 2-Placebo | Placebo comparator | Eligible subjects will receive matching placebo tablets Receives: Drug: Placebo |
| PART 1-Visit 2-Capsaicin | Experimental | Eligible subjects will receive maximum capsaicin dose Receives: Other: Caspaicin |
| PART 1-Visit 3-Placebo | Placebo comparator | Eligible subjects will receive matching placebo tablets Receives: Drug: Placebo |
| PART 1-Visit 3-Capsaicin | Experimental | Eligible subjects will receive matching placebo tablets incremental capsaicin doses Receives: Other: Caspaicin |
| PART 2-Visit 1-Placebo | Placebo comparator | Eligible subjects will receive matching placebo tablets Receives: Drug: Placebo |
| PART 2-Visit 1-SB-705498 | Experimental | Eligible subjects will receive SB-705498 tablets Receives: Drug: SB-705498 |
| PART 2-Visit 2-Capsaicin | Experimental | Eligible subjects will receive matching placebo tablets incremental capsaicin doses Receives: Other: Caspaicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom scores and secretion weights
Measured: up to 83 days
Secondary outcomes (5)
Peak nasal inspiratory flow changes after challenge
Measured: up to 83 days
Biomarkers levels in the nasal samples
Measured: up to 83 days
Blood levels of drug
Measured: up to 83 days
Pharmacodynamic response
Measured: up to 83 days
Safety parameters
Measured: up to 83 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study start22 Jul 2008
- Primary completion1 Mar 2009
- Study completion31 Mar 2009
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 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
- NCT00731250
- Sponsor's protocol ID
- 111611
- Status last verified
- Jul 2017
- First submitted
- 5 Aug 2008
- Last updated
- 13 Jul 2017
- 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 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled Study to Assess the Effect of Oral, Single Dose SB-705498 in a Validated Intranasal Capsaicin Challenge Model in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00731250
- Acronym / sponsor ID
- 111611
- Conditions
- Rhinitis
- Keywords
- Capsaicin challenge
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2008 (actual)
- Primary completion
- 1 Mar 2009 (actual)
- Study completion
- 31 Mar 2009 (actual)
- First posted
- 8 Aug 2008 (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 look at the affect of SB-705498 on rhinitis symptoms, as induced by capsaicin challenge
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| PART 1-Visit 1-Placebo | Placebo comparator | Drug: PlaceboEligible subjects will receive matching placebo tablets |
| PART 1-Visit 1-Capsaicin | Experimental | Other: CaspaicinEligible subjects will receive incremental capsaicin doses |
| PART 1-Visit 2-Placebo | Placebo comparator | Drug: PlaceboEligible subjects will receive matching placebo tablets |
| PART 1-Visit 2-Capsaicin | Experimental | Other: CaspaicinEligible subjects will receive maximum capsaicin dose |
| PART 1-Visit 3-Placebo | Placebo comparator | Drug: PlaceboEligible subjects will receive matching placebo tablets |
| PART 1-Visit 3-Capsaicin | Experimental | Other: CaspaicinEligible subjects will receive matching placebo tablets incremental capsaicin doses |
| PART 2-Visit 1-Placebo | Placebo comparator | Drug: PlaceboEligible subjects will receive matching placebo tablets |
| PART 2-Visit 1-SB-705498 | Experimental | Drug: SB-705498Eligible subjects will receive SB-705498 tablets |
| PART 2-Visit 2-Capsaicin | Experimental | Other: CaspaicinEligible subjects will receive matching placebo tablets incremental capsaicin doses |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy.
- Male or female between 18 and 60 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 - 29.9 kg/m2 (inclusive).
Key exclusion criteria (20 listed)
- Past medical history of rhinitis, including allergic, non-allergic rhinitis and rhinosinusitis.
- Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, other nasal malformations.
- 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.
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 |
|---|---|---|
| SB-705498Subjects will be administered a single dose of 400 mg SB-705498 | Drug | PART 2-Visit 1-SB-705498 |
| PlaceboSubjects will be administered SB-705498 matching placebo tablets | Drug | PART 1-Visit 1-Placebo, PART 1-Visit 2-Placebo, PART 1-Visit 3-Placebo, PART 2-Visit 1-Placebo |
| CaspaicinSubjects will be challenged with 0.5 µg, 5.0 µg and 50 µg intranasal dose | Other | PART 1-Visit 1-Capsaicin, PART 1-Visit 2-Capsaicin, PART 1-Visit 3-Capsaicin, PART 2-Visit 2-Capsaicin |
Primary outcome
Symptom scores and secretion weights
Time frame: up to 83 days
5 secondary outcomes
Peak nasal inspiratory flow changes after challenge
Time frame: up to 83 days
Biomarkers levels in the nasal samples
Time frame: up to 83 days
Blood levels of drug
Time frame: up to 83 days
Pharmacodynamic response
Time frame: up to 83 days
Safety parameters
Time frame: up to 83 days
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 13 Jul 2017.
- Results for study 111611 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- 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.
Related trials for Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingObservational study
A Study to Evaluate Treating Watery Noses With Cryotherapy in the Clinic Setting. This is Cold Therapy, Freezing the Issues at the Back of the Nose to Ease Symptoms.
Chronic Rhinitis
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
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 1 study testing SB-705498 and Caspaicin in people with Rhinitis, run by GlaxoSmithKline at 1 site in Netherlands.
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 20 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 13 Jul 2017. 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 Netherlands. 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 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.
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?
Symptom scores and secretion weights (time frame: up to 83 days). 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 13 Jul 2017.