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

Seasonal Allergic Rhinitis Clinical Trial

— GEYSER  

Official title:

A Four-Way Double-Blind, Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of Azelastine Nasal Spray and Antihistaminic Agents in Adult Subjects With Allergen Induced Seasonal Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561717
• Other study ID #: 12962
• Secondary ID: 9427-B2171-22C (
• Status: Completed
• Phase: Phase 4
• First received: November 20, 2007
• Last updated: May 5, 2013
• Start date: October 2007
• Est. completion date: February 2008

Study information

• Verified date: May 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: February 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Azelastine and placebo
One Astelin spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.
• Loratadine and Placebo
One placebo spray per nostril plus one Loratadine 10 mg tablet. In Cross-Over-Design with other arms.
• Cetirizine and Placebo
One placebo spray per nostril plus one 10 mg Cetirizine tablet. In Cross-Over-Design with other arms.
• Placebo and Placebo (spray and Tablet)
One placebo spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Kingston General Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change from baseline for individual symptoms of allergic seasonal rhinitis; overall assessment of efficacy		Effect over 6 hours	No

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