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

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00561717

Collaborator

Kingston Health Sciences Centre (Other)

Enrollment

Location

Arms

Duration (Months)

17.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Seasonal Allergic Rhinitis	Drug: Azelastine and placebo Drug: Loratadine and Placebo Drug: Cetirizine and Placebo Drug: Placebo and Placebo (spray and Tablet)	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2007

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	Drug: Azelastine and placebo One Astelin spray per nostril plus one placebo tablet. In Cross-Over-Design with other arms.
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.
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.
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.

Outcome Measures

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 [Up to 6 hours]

Secondary Outcome Measures

Change from baseline for individual symptoms of allergic seasonal rhinitis; overall assessment of efficacy [Effect over 6 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.