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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00430157
First received: January 30, 2007
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Rhinitis, Allergic, Seasonal
Seasonal Allergic Rhinitis
Drug: GSK256066
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Weighted mean total nasal symptom score (TNSS) (sneeze, itch, rhinorrhoea and obstruction) [ Time Frame: 1-4h post-dose period spent in the Vienna Challenge Chamber on Day 7 ]

Secondary Outcome Measures:
  • Weighted mean total nasal symptom score (TNSS) (sneeze, itch, rhinorrhoea and obstruction) [ Time Frame: 1-4h post morning dose period spent in the Vienna Challenge Chamber on Day 2. ]

Enrollment: 45
Study Start Date: January 2007
Intervention Details:
    Drug: GSK256066
    Other Name: GSK256066
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT00430157

Locations
Austria
GSK Investigational Site
Vienna, Austria, A-1150
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00430157     History of Changes
Other Study ID Numbers: IPR107498
Study First Received: January 30, 2007
Last Updated: May 31, 2012
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by GlaxoSmithKline:
Vienna Challenge Chamber
Seasonal Allergic Rhinitis
Inflammation

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on September 14, 2014