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

Study Overview
=================
Brief Summary
-----------------
Finding out how fast azelastine nasal spray works in subjects with hay fever.

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

Conditions
-----------------
Seasonal Allergic Rhinitis

Intervention / Treatment
-----------------
* Drug: Azelastine and placebo
* Drug: Loratadine and Placebo
* Drug: Cetirizine and Placebo
* Drug: Placebo and Placebo (spray and Tablet)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Seasonal Allergic Rhinitis, Ragweed, Pollen, Allergy