CompletedNCT00851344Updated Nov 6, 2016

Allergen Challenge Chamber Study With Single Dose Oral GSK835726 Compared With Placebo

A Phase 2 interventional study of GSK835726 (10mg) and GSK835726 (50mg) in Rhinitis, Allergic, Seasonal, sponsored by GlaxoSmithKline. Completed at 1 site in Germany. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-11-06.

Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 54
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: Male

Study 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

Conditions studied

Rhinitis, Allergic, Seasonal

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Keywords

Proof-of-Concept
Allergic Rhinitis

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 54 is below the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: Male
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 54 participants (actual)

Study arms

Active comparator
GSK835726 (10mg)
10mg oral dose
Drug: GSK835726 (10mg)
Active comparator
GSK835726 (50mg)
50mg oral dose
Drug: GSK835726 (50mg)
Active comparator
GSK835726 (100mg)
50mg oral dose
Drug: GSK835726 (100mg)
Active comparator
Cetirizine 10mg
10mg cetirizine as active comparator
Drug: Cetirizine (10mg)
Placebo comparator
placebo
placebo tablet
Other: Placebo

Interventions

DrugGSK835726 (10mg)
GSK835726 (10mg) tablet
DrugGSK835726 (50mg)
GSK835726 (50mg) tablet
DrugGSK835726 (100mg)
GSK835726 (100mg) tablet
DrugCetirizine (10mg)
Cetirizine (10mg) tablet as positive control
OtherPlacebo
Placebo to match active

What researchers measure

Primary outcomes

Change from baseline in total nasal symptom score 0-4 hours post dose
Time frame: 0-4 hours post dose

Study locations

1 site

GSK Investigational Site
Hannover, Niedersachsen 30625, Germany

References and documents

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 ↗

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 6, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00851344
Lead sponsor: GlaxoSmithKline
Responsible party: Sponsor
First posted: Feb 25, 2009
Start date: Sep 2008
Primary completion: Nov 2008
Completion: Nov 2008
Last update: Nov 6, 2016

Study contacts

GSK Clinical Trials

study director · GlaxoSmithKline

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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