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

May 5, 2013 updated by: Bayer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L 2V7

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 2
Drug: Loratadine and Placebo
One placebo spray per nostril plus one Loratadine 10 mg tablet. In Cross-Over-Design with other arms.
Experimental: Arm 1
Drug: Azelastine and placebo
One Astelin spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.
Placebo Comparator: Arm 4
Drug: Placebo and Placebo (spray and Tablet)
One placebo spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.
Active Comparator: Arm 3
Drug: Cetirizine and Placebo
One placebo spray per nostril plus one 10 mg Cetirizine tablet. In Cross-Over-Design with other arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Up to 6 hours
Up to 6 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline for individual symptoms of allergic seasonal rhinitis; overall assessment of efficacy
Time Frame: Effect over 6 hours
Effect over 6 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Queen's University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

November 20, 2007

First Submitted That Met QC Criteria

November 20, 2007

First Posted (Estimate)

November 21, 2007

Study Record Updates

Last Update Posted (Estimate)

May 7, 2013

Last Update Submitted That Met QC Criteria

May 5, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12962
  • 9427-B2171-22C (CR Number) (Other Identifier: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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