A Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of a Nasal Spray in Allergen Induced Seasonal Allergic Rhinitis

Phase 4

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: Azelastine and placebo; Drug: Cetirizine and Placebo; Drug: Loratadine and Placebo; Drug: Placebo and Placebo (spray and Tablet)

• Registration Number: NCT00561717
• Lead Sponsor: Bayer

Brief Summary

Finding out how fast azelastine nasal spray works in subjects with hay fever.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-20
• Study First Submitted QC: 2007-11-20
• Study First Posted: 2007-11-21
• Primary Completion: 2007-12
• Study Completion: 2008-02
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-05
• Last Update Posted: 2013-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• History of seasonal allergic rhinitis to ragweed pollen for last 2 consecutive seasons;
• Positive response to skin prick test to ragweed allergen at screening;
• Be willing to participate in the trial.

Exclusion Criteria

• History of hypersensitivity to azelastine;
• Females who are pregnant or lactating;
• Relative chronic sinusitis or nasal structural abnormalities causing greater than 50% obstruction;
• Asthma that requires other than occasional use of inhaled short-acting beta-2 antagonist;
• Known non-responsiveness to antihistamines;
• Alcoholism or drug abuse within 2 yrs. of screening;
• Current or regular use within 6 months of any type of tobacco product;
• Evidence of any clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or malignancies within the last 5 years;
• History of a positive test to HIV, TB, hepatitis B or C.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Azelastine and placebo	-
Arm 3	Cetirizine and Placebo	-
Arm 2	Loratadine and Placebo	-
Arm 4	Placebo and Placebo (spray and Tablet)	-

Primary Outcome Measures

Name	Time	Method
Onset of action measured by change in total nasal symptom score Until "Onset of action" = until drug demonstrates and maintains a change greater than placebo compared to baseline	Up to 6 hours

Secondary Outcome Measures

Name	Time	Method
Change from baseline for individual symptoms of allergic seasonal rhinitis; overall assessment of efficacy	Effect over 6 hours