723/726 Proof of Concept Study in Allergen Challenge Chamber in Hannover

Rhinitis, Allergic, Seasonal Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled 4-period Cross-over Study to Assess the Efficacy and Safety of Repeat Dose Intranasal GSK1004723 (1000µg), Oral GSK835726 (10mg) and Cetirizine (10mg) in the Environmental Challenge Chamber in Subjects With Seasonal Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972504
• Other study ID #: 112864
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2009
• Last updated: October 11, 2016
• Start date: June 2009
• Est. completion date: August 2009

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Land Authority for Health and Social Issues
• Study type: Interventional

Clinical Trial Summary

This is a randomised, double-blind, placebo-controlled 4-period cross-over study to assess the efficacy and safety of repeat dose intranasal GSK1004723 (1000µg), oral GSK835726 (10mg) and cetirizine (10mg) in the environmental challenge chamber in subjects with seasonal allergic rhinitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.

• Males or female using contraceptives

• Aged 18 - 65

• Weight 50kg+, BMI 19-32 kg/m2

• Exhibit response to Challenge Chamber and skin prick test.

• Non-smoker

• Capable of giving informed consent

• AST and ALT<2xULN; alkaline phosphatase and bilirubin <or=1.5xULN

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

• Pregnant or llactating females

• 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• GSK835726 10mg
GSK835726 10mg tablet
• GSK1004723 1000mcg
GSK1004723 1000mcg nasal spray solution
• Cetirizine 10mg
Cetirizine 10mg active comparator
• placebo
placebo to match actives

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 1-7 hours post dose		1-7 hours post dose	No

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.