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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00561717

Acronym

GEYSER

Enrollment

Registered

2007-11-21

Start date

2007-10-31

Completion date

2008-02-29

Last updated

2013-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal Allergic Rhinitis

Keywords

Seasonal Allergic Rhinitis, Ragweed, Pollen, Allergy

Brief summary

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

Interventions

DRUGLoratadine and Placebo

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

DRUGAzelastine and placebo

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

DRUGCetirizine and Placebo

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

DRUGPlacebo and Placebo (spray and Tablet)

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

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	Up to 6 hours

Secondary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026