Clinical Trial: A Phase II Study Evaluating Intranasal GSK256066 and Fluticasone Propionate in Subjects With Seasonal Allergic Rhinitis (SAR)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An 8 Day, Randomised, Double Blind, 3-way Crossover Trial of Repeat Doses of Intranasal GSK256066 and Fluticasone Propionate in the Vienna Challenge Chamber in Subjects With Seas

Brief Summary: This is an 8 day, randomised, double blind, 3-way crossover trial of repeat doses of intranasal GSK256066 and fluticasone propionate in the Vienna Challenge Chamber in subjects with seasonal allergic rhinitis (SAR). Approximately 60 subjects will be selected for enrolment with the intention of acquiring at least 48 evaluable subjects. Laboratory safety assessments, 12-lead electrocardiograph (ECG), vital signs and adverse event enquiries will be made throughout the study. Nasal examination, symptom scores, nasal lavage, nasal scrape and allergen challenge assessments will also be performed at various time points throughout the study.

Detailed Summary:
Sponsor: GlaxoSmithKline

Current Primary Outcome: Investigate effect of repeat intranasal doses of fluticasone propionate alone vs. GSK256066 + fluticasone propionate on nasal symptoms of allergic rhinitis provoked by spending 4 hours in the Vienna Challenge Chamber after morning dosing on Day 2. [ Time Frame: spending 4 hours in the Vienna Challenge Chamber after morning dosing on Day 2. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • •Nasal symptoms [ Time Frame: provoked after Day 2 dose. ]
  • •Nasal symptoms [ Time Frame: after Day 8 dose. ]
  • Eye and global symptoms, nasal obstruction and secretions [ Time Frame: after Day 2 and 8 dose. ]
  • Weighted mean TNSS (sneeze, itch, rhinorrhoea and obstruction) [ Time Frame: 1 to 4hours post morning dose period spent in the Vienna Challenge Chamber on Day 8. ]
  • Weighted mean eye symptom score (watery eyes, itchy eyes, red eyes) [ Time Frame: over 1 to 4 hours on Day 2 and 8. ]
  • Weighted mean global symptom score (sneeze, itch, rhinorrhoea, obstruction, cough, itchy throat, itchy ears, watery eyes, itchy eyes and red eyes) [ Time Frame: over 1 to 4 hours on Day 2 and 8. ]
  • Weighted mean nasal airflow resistance (measured using active anterior rhinomanometry) and secretion weight (measured by weighing tissues) [ Time Frame: over 1 to 4 hours on Day 2 and 8. ]
  • Weighted mean components of TNSS (sneeze, itch, rhinorrhoea and obstruction) [ Time Frame: over 1 to 4 hours on Day 2 and 8. ]
  • FEV1, ECGs, Vitals, AEs, and laboratory safety parameters.
  • Effect of GSK256066 on ribonucleic acid (RNA) levels indicative of PDE4 inhibition in nasal scrape samples and on protein biomarkers of PDE4 inhibition in lavage samples
  • Effect of fluticasone propionate on RNA levels indicative of glucocorticoid-provoked gene expression in nasal scrape samples and on glucocorticoid receptor (GR) translocation in lavage samples


Original Secondary Outcome: Same as current

Information By: GlaxoSmithKline

Dates:
Date Received: January 29, 2008
Date Started: January 2008
Date Completion:
Last Updated: November 2, 2016
Last Verified: November 2016