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

NCT00972504 | Completed Phase 2 Results

• 1 other identifier: 112864
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rhinitis, Allergic, Seasonal

Keywords

Proof of concept

Outcome Measures

Primary Outcomes (1)

• Weighted Mean TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3

  On the third dosing day, participants entered the ECC for a duration of 6 hours, 1 hour after receiving their third dose. Time 0 hour was considered as the time that the participant entered the ECC. Nasal blockage, itch, sneeze and rhinorrhoea was scored on a categorical scale from 0 to 3 (0: no symptoms; 1: mild symptoms; 2: moderate symptoms; 3: severe symptoms). The total TNSS ranged from 0-12 point, with low score indicates well-being and higher score indicates more severity. Individual symptoms scores was summed at each time point (0, 20, 40, 60, 80, 100, 120, 140, 160, 180, 200, 220, 240, 260, 280, 300, 320, 340 and 360 minutes). The adjusted mean is provided as least square mean.

  Day 3 of each treatment period (approximately up to 63 days)

Secondary Outcomes (5)

• Weighted Mean of the Individual Components of TNSS (Sneeze, Itch, Rhinorrhoea and Nasal Blockage) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3

  Day 3 of each treatment period (approximately up to 63 days)

• Weighted Mean Wet Tissue Weight (as a Surrogate Marker of Nasal Secretion) 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3

  Day 3 of each treatment period (approximately up to 63 days)

• Weighted Mean Nasal Congestion VAS 1-6 Hours Post Start of Allergen Challenge (2-7 Hours Post-dose) on Day 3

  Day 3 of each treatment period (approximately up to 63 days)

• Mean Forced Expiratory Volume in 1 Second (FEV1)

  Day 3 of each treatment period (approximately up to 63 days)

• Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

  approximately up to 63 days

Study Arms (4)

GSK835726 (10mg)

ACTIVE COMPARATOR

10mg oral dose

Drug: GSK835726 10mg

GSK1004723 (1000mcg)

ACTIVE COMPARATOR

1000mcg nasal spray solution

Drug: GSK1004723 1000mcg

Cetirizine 10mg

ACTIVE COMPARATOR

10mg cetirizine as active comparator

Drug: Cetirizine 10mg

placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

GSK835726 10mg DRUG

GSK835726 10mg tablet

GSK835726 (10mg)

GSK1004723 1000mcg DRUG

GSK1004723 1000mcg nasal spray solution

GSK1004723 (1000mcg)

Cetirizine 10mg DRUG

Cetirizine 10mg active comparator

Cetirizine 10mg

placebo DRUG

placebo to match actives

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Hanover, Lower Saxony, 30625, Germany

Location

Related 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.

  PMID: 22212854 BACKGROUND

Related 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.

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

GSK 835726; GSK 1004723; Cetirizine

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: September 7, 2009
• Study Start: June 1, 2009
• Primary Completion: August 1, 2009
• Study Completion: August 14, 2009
• Last Updated: August 2, 2017
• Results First Posted: August 2, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)