Rhinitis, Allergic, SeasonalPhase 2NCT00851344
Allergen Challenge Chamber Study With Single Dose Oral GSK835726 Compared With Placebo
A Phase 2 study testing GSK835726 (10mg), GSK835726 (50mg) and GSK835726 (100mg) in people with Rhinitis, Allergic, Seasonal, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
A randomised, double-blind, placebo-controlled, 4-period incomplete block crossover study of single oral dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and placebo to evaluate the efficacy and safety using an Environmental challenge chamber in male subjects with seasonal allergic rhinitis Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Rhinitis, Allergic, Seasonal
- What is being tested?
- GSK835726 (10mg), GSK835726 (50mg) and GSK835726 (100mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2008to Nov 2008
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.
- Male
- Aged 18 - 60
- Weight 50kg+, BMI 19-32 kg/m2
- Exhibit response to Challenge Chamber and skin prick test.
- Non-smoker
- Capable of giving informed consent
Who cannot join
- No nasal structural abnornmality/polyposis, surgery, infection.
- any respiratory disease, other than mild asthma or seasonal allergic rhinitis
- participated in another clinical study within 30 days.
- Subject has donated a unit of blood within 1 month
- Use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial.
- History of sensitivty to drug
Show all 14Show fewer
- History of alcohol/drug abuse within 12 months.
- Positive Hepatitis B antibody test
- Positive HIV antibody test
- Risk of non-compliance with study protocol
- Perenial allergic rhinitis
- Administration of oral, injectable or dermal corticosteriods within 8 weeks, intranasal or inhaled within 3 weeks.
- Past or present disease that may affect outcome, as judge by investigator
- Specific Immunotherapy within 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, 4-period Incomplete Block Crossover Study of Single Oral Dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and Placebo to Evaluate the Efficacy and Safety Using an Environmental Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis
A randomised, double-blind, placebo-controlled, 4-period incomplete block crossover study of single oral dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and placebo to evaluate the efficacy and safety using an Environmental challenge chamber in male subjects with seasonal allergic rhinitis
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- GSK835726 (10mg), GSK835726 (50mg), GSK835726 (100mg), Cetirizine (10mg), Placebo
- Keywords
- Proof-of-Concept, Allergic Rhinitis
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK835726 (10mg)Drug
GSK835726 (10mg) tablet
GSK835726 (50mg)Drug
GSK835726 (50mg) tablet
GSK835726 (100mg)Drug
GSK835726 (100mg) tablet
Cetirizine (10mg)Drug
Cetirizine (10mg) tablet as positive control
PlaceboOther
Placebo to match active
| Study group | Role | What they receive |
|---|---|---|
| GSK835726 (10mg) | Active comparator | 10mg oral dose Receives: Drug: GSK835726 (10mg) |
| GSK835726 (50mg) | Active comparator | 50mg oral dose Receives: Drug: GSK835726 (50mg) |
| GSK835726 (100mg) | Active comparator | 50mg oral dose Receives: Drug: GSK835726 (100mg) |
| Cetirizine 10mg | Active comparator | 10mg cetirizine as active comparator Receives: Drug: Cetirizine (10mg) |
| placebo | Placebo comparator | placebo tablet Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total nasal symptom score 0-4 hours post dose
Measured: 0-4 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startSep 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, Allergic, SeasonalStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 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
- NCT00851344
- Sponsor's protocol ID
- 110163
- Status last verified
- Nov 2016
- First submitted
- 24 Feb 2009
- Last updated
- 7 Nov 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.
Publications
Daley-Yates P, Ambery C, Sweeney L, Watson J, Oliver A, McQuade B. The efficacy and tolerability of two novel H(1)/H(3) receptor antagonists in seasonal allergic rhinitis. Int Arch Allergy Immunol. 2012;158(1):84-98. doi: 10.1159/000329738. Epub 2011 Dec 29.
PubMed 22212854
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, 4-period Incomplete Block Crossover Study of Single Oral Dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and Placebo to Evaluate the Efficacy and Safety Using an Environmental Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00851344
- Acronym / sponsor ID
- 110163
- Conditions
- Rhinitis, Allergic, Seasonal
- Keywords
- Proof-of-Concept, Allergic Rhinitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 25 Feb 2009 (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.
A randomised, double-blind, placebo-controlled, 4-period incomplete block crossover study of single oral dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and placebo to evaluate the efficacy and safety using an Environmental challenge chamber in male subjects with seasonal allergic rhinitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GSK835726 (10mg) | Active comparator | Drug: GSK835726 (10mg)10mg oral dose |
| GSK835726 (50mg) | Active comparator | Drug: GSK835726 (50mg)50mg oral dose |
| GSK835726 (100mg) | Active comparator | Drug: GSK835726 (100mg)50mg oral dose |
| Cetirizine 10mg | Active comparator | Drug: Cetirizine (10mg)10mg cetirizine as active comparator |
| placebo | Placebo comparator | Other: Placeboplacebo tablet |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.
- Male
- Aged 18 - 60
- Weight 50kg+, BMI 19-32 kg/m2
- Exhibit response to Challenge Chamber and skin prick test.
Key exclusion criteria (14 listed)
- No nasal structural abnornmality/polyposis, surgery, infection.
- any respiratory disease, other than mild asthma or seasonal allergic rhinitis
- participated in another clinical study within 30 days.
- Subject has donated a unit of blood within 1 month
- Use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial.
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 |
|---|---|---|
| GSK835726 (10mg)GSK835726 (10mg) tablet | Drug | GSK835726 (10mg) |
| GSK835726 (50mg)GSK835726 (50mg) tablet | Drug | GSK835726 (50mg) |
| GSK835726 (100mg)GSK835726 (100mg) tablet | Drug | GSK835726 (100mg) |
| Cetirizine (10mg)Cetirizine (10mg) tablet as positive control | Drug | Cetirizine 10mg |
| PlaceboPlacebo to match active | Other | placebo |
Primary outcome
Change from baseline in total nasal symptom score 0-4 hours post dose
Time frame: 0-4 hours post dose
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 7 Nov 2016.
- Background: PubMed 22212854Daley-Yates P, Ambery C, Sweeney L, Watson J, Oliver A, McQuade B. The efficacy and tolerability of two novel H(1)/H(3) receptor antagonists in seasonal allergic rhinitis. Int Arch Allergy Immunol. 2012;158(1):84-98. doi: 10.1159/000329738. Epub 2011 Dec 29.
- 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, Allergic, Seasonal
RecruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
Birch Pollen Allergy
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
Pollen Allergy
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis
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 GSK835726 (10mg), GSK835726 (50mg) and GSK835726 (100mg) in people with Rhinitis, Allergic, Seasonal, run by GlaxoSmithKline at 1 site in Germany.
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 7 inclusion and 14 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 7 Nov 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 Germany. 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?
Change from baseline in total nasal symptom score 0-4 hours post dose (time frame: 0-4 hours post dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00851344, which also lists 1 linked publication.
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 7 Nov 2016.