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Randomised, Double-blind, Triple Dummy, Partial Cross-over (Each Active Treatment With Placebo) Study Using an Environmental Challenge Chamber (ECC) to Assess the Safety and Efficacy of 2 Weeks of Oral BI 671800 ED 50, 200 or 400 mg Bid, Compared to Montelukast 10 mg qd, Fluticasone Propionate Nasal Spray 200 mcg qd (2 Nasal Actuations Each Nostril of 50 mcg) Versus Placebo in Seasonal Allergic Rhinitis Patients Out of Season, Sensitive to Dactylis Glomerata.

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Trial Profile

Randomised, Double-blind, Triple Dummy, Partial Cross-over (Each Active Treatment With Placebo) Study Using an Environmental Challenge Chamber (ECC) to Assess the Safety and Efficacy of 2 Weeks of Oral BI 671800 ED 50, 200 or 400 mg Bid, Compared to Montelukast 10 mg qd, Fluticasone Propionate Nasal Spray 200 mcg qd (2 Nasal Actuations Each Nostril of 50 mcg) Versus Placebo in Seasonal Allergic Rhinitis Patients Out of Season, Sensitive to Dactylis Glomerata.

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 27 Sep 2013

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At a glance

  • Drugs BI 671800 (Primary) ; Fluticasone propionate; Montelukast
  • Indications Seasonal allergic rhinitis
  • Focus Therapeutic Use

    • Most Recent Events

    • 21 Apr 2012 Planned number of patients changed from 150 to 300 as reported by European Clinical Trials Database record.
    • 21 Apr 2012 New source identified and integrated (European Clinical Trials Database; EudraCT2009-013269-24).
    • 12 May 2010 Actual patient number (146) added as reported by ClinicalTrials.gov.
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