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 Seasonal 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