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

Rhinitis, Allergic, Seasonal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00851344
• Other study ID #: 110163
• Status: Completed
• Phase: Phase 2
• First received: February 24, 2009
• Last updated: November 4, 2016
• Start date: September 2008
• Est. completion date: November 2008

Study information

• Verified date: November 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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:

• 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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal

Intervention

Drug:
• GSK835726 (10mg)
GSK835726 (10mg) tablet
• GSK835726 (50mg)
GSK835726 (50mg) tablet
• GSK835726 (100mg)
GSK835726 (100mg) tablet
• Cetirizine (10mg)
Cetirizine (10mg) tablet as positive control

Other:
• Placebo
Placebo to match active

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Hannover	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in total nasal symptom score 0-4 hours post dose		0-4 hours post dose

External Links

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