Onset of Effect of Mometasone Nasal Spray in Induced Allergic Rhinitis (Study P03431)

Study Overview
=================
Brief Summary
-----------------
This was a single-dose study to determine the time it takes for mometasone furoate nasal spray to go in effect, after a single dose of 2 sprays per nostril. Patients who are eligible were exposed to ragweed pollen for 3 hours on one or two occasions. Patients who experienced adequate symptoms during the pollen exposure phase came back for a Treatment Phase visit. During the Treatment Phase visit, patients were exposed to ragweed pollen for 2 hours and then received either mometasone or placebo nasal spray. Symptom evaluations began on the patients every hour for the next 11 hours.

Official Title
-----------------
Onset of Action of Mometasone Furoate Nasal Spray vs. Placebo in Induced Allergic Rhinitis

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

Intervention / Treatment
-----------------
* Drug: Mometasone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 12 years old, had a history of SAR to ragweed pollen for at least one year had a positive skin test (prick) to short ragweed allergen. if female, had a negative urine pregnancy test (HCG) at the Screening Visit, and prior to treatment on the Treatment Visit were non pregnant women of childbearing potential and used a medically acceptable, adequate form of birth control. Exclusion Criteria: developed signs or symptoms of bronchospasm, i.e., wheezing, dyspnea, and/or cough, during the priming sessions; had any significant medical condition which, in the judgment of the investigator, might interfere with the study or require treatment; had an upper respiratory or sinus infection within two weeks prior to treatment; had received escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy for treatment of rhinitis; were female subjects who were pregnant, breast feeding, or premenarchal; could not adhere to concomitant medication prohibitions; had a known potential for hypersensitivity, allergy, or idiosyncratic reaction to mometasone furoate nasal spray; had asthma that requires systemic or inhaled corticosteroid treatment; had large nasal polyps, marked septum deviations, or any other nasal structural abnormality that significantly interferes with nasal airflow; had rhinitis medicamentosa; had any relevant abnormal vital sign due to an unknown underlying disease and considered by the investigator and Sponsor Monitor to contraindicate study participation.

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mometasone Furoate Nasal Spray<br> | Drug: Mometasone<br>* Mometasone Furoate Nasal Spray, single dose of 200 mcg (2 sprays per nostril)<br>* Other names: Nasonex, SCH 032088;|
| Placebo Comparator: Placebo Nasal Spray<br> | Drug: Placebo<br>* Placebo nasal spray, single dose of 2 sprays per nostril<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Nasal Symptom Score (TNSS) |  | On the day of treatment, after 90 and 120 minutes of pollen exposure and every 60 minutes post-dose for 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal and Non-Nasal symptoms, Total Nasal and Total Non-Nasal symptoms, Total Symptom Score, Global Therapeutic Response |  | On the day of treatment, after 90 and 120 minutes of pollen exposure and every 60 minutes post-dose for 12 hours |