Last updated: 07/13/2020 16:20:04

Trial With Allergic Rhinitis Patients taking GSK256066 Versus Placebo In A Pollen Challenge Chamber

GSK study ID
IPR107498
See study documents
Clinicaltrials.gov ID
NCT00430157
EudraCT ID
2006-006000-11
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: An 8 day, randomised, double blinded, placebo-controlled 2-way crossover trial of repeat doses of intranasal GSK256066 and placebo in the Vienna Challenge Chamber in subjects with seasonal allergic rhinitis (SAR)
Trial description: This study is in patients with seasonal allergic rhinitis (SAR) and will compare the effect versus placebo of repeat doses of intranasal GSK256066 using the Vienna Challenge Chamber. GSK256066 is a potent and highly selective phosphodiesterase-4 (PDE4) inhibitor, currently in development by GSK for the treatment of allergic rhinitis, asthma and COPD.
Subjects will be selected on the basis that they display a defined moderate response to the pre-determined dose used.
This study aims to explore the actions of repeat doses of intranasal GSK256066 in patients with Seasonal Allergic Rhinitis in the Vienna Challenge Chamber compared to placebo.
12-lead ECG, vital signs and adverse event enquiries will be made throughout the study. Nasal examination, symptom scores (TNSS), nasal lavage, nasal scrape and allergen challenge assessments will also be performed at various time points throughout the study.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Weighted mean total nasal symptom score (TNSS) (sneeze, itch, rhinorrhoea and obstruction)

Timeframe: 1-4h post-dose period spent in the Vienna Challenge Chamber on Day 7

Secondary outcomes:

Weighted mean total nasal symptom score (TNSS) (sneeze, itch, rhinorrhoea and obstruction)

Timeframe: 1-4h post morning dose period spent in the Vienna Challenge Chamber on Day 2.

Interventions:
Drug: GSK256066
Enrollment:
45
Observational study model:
Not applicable
Primary completion date:
2007-14-03
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Rhinitis, Allergic, Seasonal
Product
GSK256066
Collaborators
Not applicable
Study date(s)
January 2007 to March 2007
Type
Interventional
Phase
2

Participation criteria

Sex
Female & Male
Age
18 - 50 years
Accepts healthy volunteers
No
  • The subject is healthy.
  • They are aged 18 to 50 years inclusive.
  • Pregnant or nursing females.
  • Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception.
Inclusion and exclusion criteria
Inclusion criteria:
  • The subject is healthy.
  • They are aged 18 to 50 years inclusive.
  • Body mass index less than 29.0 kg/m² with weight range of 55.0kg (females 50kg) to 95.0kg inclusive.
  • They have a history of seasonal allergic rhinitis
  • They exhibit a moderate response to 1500 grass pollen grains/m3 after 2h in the Vienna Challenge Chamber,
  • They have a positive skin prick test for grass pollen at or within the 12 months preceding the screening visit.
  • They have a positive RAST for grass pollen at or within the 12 months preceding the screening visit.
  • They are current non-smokers who have not used any tobacco products in the 6 months preceding the screening visit
  • They must have a baseline FEV1>80% predicted and a baseline FEV1 (maximum recorded value)/ FVC (associated value)>70% predicted.
Exclusion criteria:
  • Pregnant or nursing females.
  • Women of childbearing potential who are unwilling or unable to use an appropriate method of contraception.
  • any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or recent (within 2 weeks) or ongoing upper respiratory tract infection.
  • The subject is likely to be unable to abstain from salbutamol use for 8 hours before a challenge
  • The subject has a history of drug or other allergy
  • The subject is concurrently participating in another clinical study in the past 3 months
  • A supine blood pressure that is persistently higher than 140/90 millimetres of mercury (mmHg) at screening
  • A supine mean heart rate outside the range 40-90 beats per minute (bpm) at screening.
  • The subject has donated a unit of blood within the previous 3 months.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Vienna, Austria, A-1150
Status
Study Complete
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Study documents

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

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

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
2007-14-03
Actual study completion date
2007-14-03

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

Additional information
Not applicable
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