check_circleStudy Completed

Seasonal Allergic Rhinitis

Bayer Identifier:

12962

ClinicalTrials.gov Identifier:

NCT00561717

EudraCT Number:

Not Available

EU CT Number:

Not Available
A Randomized, Placebo Controlled Study to Determine the Efficacy and Speed of a Nasal Spray in Allergen Induced Seasonal Allergic Rhinitis

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - 65 Years
  • - 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.
  • - 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.

Trial summary

Enrollment Goal
70
Trial Dates
October 2007 - February 2008
Phase
Phase 4
Could I Receive a placebo
Yes
Products
Astelin (Azelastine, BAYR9258)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Kingston General HospitalKingston, K7L 2V7, Canada

Primary Outcome

  • 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
    date_rangeTime Frame:
    Up to 6 hours
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • Change from baseline for individual symptoms of allergic seasonal rhinitis; overall assessment of efficacy
    date_rangeTime Frame:
    Effect over 6 hours
    enhanced_encryption
    Safety Issue:
    no

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Crossover Assignment
Trial Arms
4

Additional Information

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