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

Primary Purpose

Seasonal Allergic Rhinitis

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Azelastine and placebo

Loratadine and Placebo

Cetirizine and Placebo

Placebo and Placebo (spray and Tablet)

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring Seasonal Allergic Rhinitis, Ragweed, Pollen, Allergy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline for individual symptoms of allergic seasonal rhinitis; overall assessment of efficacy

Full Information

NCT ID

NCT00561717

First Posted

November 20, 2007

Last Updated

May 5, 2013

Sponsor

Bayer

Collaborators

Queen's University

1. Study Identification

Unique Protocol Identification Number

NCT00561717

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bayer

Collaborators

Queen's University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Seasonal Allergic Rhinitis

Keywords

Seasonal Allergic Rhinitis, Ragweed, Pollen, Allergy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Title

Arm 2

Arm Type

Active Comparator

Arm Title

Arm 3

Arm Type

Active Comparator

Arm Title

Arm 4

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Azelastine and placebo

Intervention Description

One Astelin spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.

Intervention Type

Drug

Intervention Name(s)

Loratadine and Placebo

Intervention Description

One placebo spray per nostril plus one Loratadine 10 mg tablet. In Cross-Over-Design with other arms.

Intervention Type

Drug

Intervention Name(s)

Cetirizine and Placebo

Intervention Description

One placebo spray per nostril plus one 10 mg Cetirizine tablet. In Cross-Over-Design with other arms.

Intervention Type

Drug

Intervention Name(s)

Placebo and Placebo (spray and Tablet)

Intervention Description

One placebo spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Change from baseline for individual symptoms of allergic seasonal rhinitis; overall assessment of efficacy

Time Frame

Effect over 6 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 2V7

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

29371864

Citation

Tenn MW, Steacy LM, Ng CC, Ellis AK. Onset of action for loratadine tablets for the symptomatic control of seasonal allergic rhinitis in adults challenged with ragweed pollen in the Environmental Exposure Unit: a post hoc analysis of total symptom score. Allergy Asthma Clin Immunol. 2018 Jan 16;14:5. doi: 10.1186/s13223-017-0227-4. eCollection 2018.

Results Reference

derived

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

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