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

Bayer

Status and phase: Completed; Phase 4

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Cetirizine and Placebo; Drug: Azelastine and placebo; Drug: Loratadine and Placebo; Drug: Placebo and Placebo (spray and Tablet)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00561717

12962

9427-B2171-22C (CR Number) (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 70 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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70 participants in 4 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Azelastine and placebo

Arm 2

Active Comparator group

Treatment:

Drug: Loratadine and Placebo

Arm 3

Active Comparator group

Treatment:

Drug: Cetirizine and Placebo

Arm 4

Placebo Comparator group

Treatment:

Drug: Placebo and Placebo (spray and Tablet)