Last updated: 11/07/2018 02:54:11

Allergen Challenge Chamber Study With Single Dose Intranasal GSK1004723 Compared With Placebo

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GSK study ID
110159
See study documents
Clinicaltrials.gov ID
NCT00824356
See results summary
EudraCT ID
2008-001567-10
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A randomised, double-blind, placebo-controlled, 3-period crossover study to assess the efficacy and safety of single dose intranasal GSK1004723 compared with placebo in an allergen challenge chamber in male subjects with seasonal allergic rhinitis
Trial description: This is a placebo-controlled, 3-period crossover study to assess the efficacy and safety of two single doses of an intranasal anti-histamine GSK1004723 compared with placebo in an allergen challenge chamber in male subjects with seasonal allergic
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:

Total Nasal Symptom Score, TNSS (sneeze, itch, rhinorrhea, nasal blockage) upto 4 hours on Day 1

Timeframe: 0-4 hours post-dose (2-6 hours post start of allergen challenge)

Secondary outcomes:

Individual components of TNSS (sneeze, itch, rhinorrhea, nasal blockage) 0-4 hours post-dose (2-6 hours post start of allergen challenge)

Timeframe: 0-4 hours post-dose (2-6 hours post start of allergen challenge)

Weighted mean TNSS and each of its individual components (sneeze, itch, rhinorrhoea and nasal blockage) 0-4 hours post-dose (2-6 hours post start of allergen challenge)

Timeframe: 0-4 hours post-dose (2-6 hours post start of allergen challenge)

Weighted mean nasal airflow resistance (measured using active anterior rhinomanometry) 0-4 hours post-dose (2-6 hours post start of allergen challenge)

Timeframe: 0-4 hours post-dose (2-6 hours post start of allergen challenge)

Weighted mean nasal secretion weight 0-4 hours post-dose (2-6 hours post start of allergen challenge)

Timeframe: 0-4 hours post-dose (2-6 hours post start of allergen challenge)

Weighted mean Nasal Congestion Visual Analogue Scale (VAS) 0-4 hours post-dose (2-6 hours post start of allergen challenge)

Timeframe: 0-4 hours post-dose (2-6 hours post start of allergen challenge)

Weighted mean TNSS and each of its individual components (sneeze, itch, rhinorrhoea and nasal blockage) 20-24 hours post dose (0-4 hours post allergen challenge)

Timeframe: 20-24 hours post dose (0-4 hours post allergen challenge)

Weighted mean of nasal airflow resistance (measured using active anterior rhinomanometry) over 20-24 hours post dose (0-4 hour post allergen challenge)

Timeframe: 20-24 hours post dose (0-4 hour post allergen challenge)

Weighted mean of nasal secretion weight over 20-24 hours post dose (0-4 hour post allergen challenge)

Timeframe: 20-24 hours post dose (0-4 hour post allergen challenge)

Weighted mean of Nasal Congestion VAS 20-24H post-dose over 20-24 hours post dose (0-4 hour post allergen challenge)

Timeframe: 20-24 hours post dose (0-4 hour post allergen challenge)

Mean Forced expiratory volume in 1 second (FEV1) pre-dose and over 24H post-dose

Timeframe: Day 1 and Day 2

Number of participants with adverse events and serious adverse events

Timeframe: Up to Week 10

Interventions:
Drug: GSK1004723 (1000mg)
Drug: GSK1004723 (200mg)
Other: Placebo
Enrollment:
54
Observational study model:
Not applicable
Primary completion date:
2008-28-08
Time perspective:
Not applicable
Clinical publications:
Daley-Yates P, Ambery C, Sweeney L, Watson J, Oliver A, McQuade B. The efficacy and tolerability of two novel H1/H3 receptor antagonists in seasonal allergic rhinitis. [Int Arch Allergy Immunol]. 2012;158:84-98.
Medical condition
Rhinitis, Allergic, Seasonal
Product
GSK1004723
Collaborators
Not applicable
Study date(s)
June 2008 to August 2008
Type
Interventional
Phase
2

Participation criteria

Sex
Male
Age
18 - 65 years
Accepts healthy volunteers
No
  • Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.
  • Male
  • No nasal structural abnornmality/polyposis, surgery, infection.
  • any respiratory disease, other than mild asthma or seasonal allergic rhinitis
Inclusion and exclusion criteria
Inclusion criteria:
  • Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma. -Male -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
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

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Terminated/Withdrawn
Contact us

Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2008-28-08
Actual study completion date
2008-28-08

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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