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

Phase 4

Completed

• Conditions: Allergic Rhinitis
• Interventions: Drug: Placebo; Drug: Mometasone

• Registration Number: NCT00783237
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12-01
• Primary Completion: 2004-02-21
• Study Completion: 2004-02-21
• Study First Submitted: 2008-10-30
• Study First Submitted QC: 2008-10-30
• Study First Posted: 2008-10-31
• Status Verified: 2022-02
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Nasal Spray	Placebo	-
Mometasone Furoate Nasal Spray	Mometasone	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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