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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00972504
First received: August 27, 2009
Last updated: May 29, 2014
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Rhinitis, Allergic, Seasonal
Drug: GSK835726 10mg
Drug: GSK1004723 1000mcg
Drug: Cetirizine 10mg
Drug: placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in total nasal symptom score 1-7 hours post dose [ Time Frame: 1-7 hours post dose ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: June 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GSK835726 (10mg)
10mg oral dose
Drug: GSK835726 10mg
GSK835726 10mg tablet
Active Comparator: GSK1004723 (1000mcg)
1000mcg nasal spray solution
Drug: GSK1004723 1000mcg
GSK1004723 1000mcg nasal spray solution
Active Comparator: Cetirizine 10mg
10mg cetirizine as active comparator
Drug: Cetirizine 10mg
Cetirizine 10mg active comparator
Placebo Comparator: placebo
placebo
Drug: placebo
placebo to match actives

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972504

Locations
Germany
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00972504     History of Changes
Other Study ID Numbers: 112864
Study First Received: August 27, 2009
Last Updated: May 29, 2014
Health Authority: Germany: Land Authority for Health and Social Issues

Keywords provided by GlaxoSmithKline:
Proof of concept

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cetirizine
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014