Last updated: 11/07/2018 02:54:29
Allergen Challenge Chamber Study With Single Dose oral GSK835726 Compared With Placebo
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:
Weighted mean total nasal symptom score (TNSS) during 0-4 hours or 2-6 hours post start of allergen challenge on Day 1
Timeframe: 0-4 h on Day 1 (post-dose)
Secondary outcomes:
Weighted mean nasal congestion score (measured as a nasal blockage component of TNSS) during 0-4 h on Day 1
Timeframe: During 0-4 h on Day 1
Weighted mean of TNSS individual components (sneeze, itch, rhinorrhea, and nasal blockage) during 0-4h and during 20-24 h on Day 1
Timeframe: During 0-4h and during 20-24 h on Day 1
Weighted mean nasal airflow resistance during 0-4h and 20- 24 h on Day 1
Timeframe: During 0-4h and 20- 24 h on Day 1
Weighted mean nasal secretion weight during 0-4h and 20-24 h on Day 1
Timeframe: During 0-4h and 20-24 h on Day 1
Weighted mean Nasal Congestion Visual Analogue Scale (VAS) during 0-4h and 20-24 h on Day 1
Timeframe: During 0-4h and 20-24 h on Day 1
Forced expiratory volume in one second (FEV1) over period
Timeframe: From screening (2 hours before dosing) up to 24 hours on Day 1
Number of participants with serious adverse events (SAEs) and adverse events (AEs)
Timeframe: Up to 10 weeks
Number of participants with Vital Signs of Potential Clinical Importance (PCI) over period
Timeframe: Up to 10 weeks
Number of participants with hematology and chemistry of Potential Clinical Importance (PCI) over period
Timeframe: Up to 10 weeks
Number of participants with electrocardiogram (ECG) findings over period
Timeframe: Up to 10 weeks
Number of participants with urinalysis parameters of Potential Clinical Importance (PCI) over period
Timeframe: Up to 10 weeks
Interventions:
Drug: GSK835726 (10mg)
Drug: GSK835726 (50mg)
Drug: GSK835726 (100mg)
Drug: Cetirizine (10mg)
Other: Placebo
Enrollment:
54
Observational study model:
Not applicable
Primary completion date:
2008-27-11
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
GSK835726
Collaborators
Not applicable
Study date(s)
September 2008 to November 2008
Type
Interventional
Phase
2
Participation criteria
Sex
Male
Age
18 - 60 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
- 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
Trial location(s)
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
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
2008-27-11
Actual study completion date
2008-27-11
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.
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