NCT00612118

A Randomised, Double Blind, 2-way Crossover Trial of 8 Days Repeat Dosing With Intranasal GSK256066 and Azelastine Hydrochloride in the Vienna Challenge Chamber in Subjects With Seasonal Allergic Rhinitis (SAR)

Completed Phase 2 Last updated 31 May 2012

What this trial tests

Phase 2 trial testing GSK256066 in Allergic Rhinitis in 70 participants. Completed in 1 May 2008.

Timeline

1 February 2008

Primary endpoint
1 May 2008

1 May 2008

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	70
Start date	1 February 2008
Primary completion	1 May 2008
Estimated completion	1 May 2008
Sites	1 location across Austria

Drugs / interventions tested

• GSK256066 — full drug profile →
• azelastine hydrochloride — full drug profile →

Conditions studied

• Allergic Rhinitis — all drugs for Allergic Rhinitis →
• Rhinitis, Allergic, Seasonal — all drugs for Rhinitis, Allergic, Seasonal →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 50, any sex, with Allergic Rhinitis or Rhinitis, Allergic, Seasonal. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Investigate effect of repeat intranasal doses of azelastine hydrochloride alone vs. GSK256066 + azelastine hydrochloride on nasal symptoms of allergic rhinitis provoked by spending 4h in the Vienna Challenge Chamber after morning dosing on Day 8.
  Time frame: spending 4h in the Vienna Challenge Chamber after morning dosing on Day 8.

Sponsor's own description

This study is an 8 day, randomised, double blind, 2-way crossover trial of repeat doses of intranasal GSK256066 and azelastine hydrochloride in the Vienna Challenge Chamber in subjects with seasonal allergic rhinitis (SAR). Laboratory safety assessments, 12-lead electrocardiograph (ECG), vital signs and adverse event enquiries will be made throughout the study. Nasal examination, symptom scores, and allergen challenge assessments will also be performed at various time points throughout the study.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Recent developments of phosphodiesterase inhibitors: Clinical trials, emerging indications and novel molecules.
   Bondarev AD, Attwood MM, Jonsson J, Chubarev VN, et al · · 2022 · cited 52× · PMID 36506513 · DOI 10.3389/fphar.2022.1057083