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

• Status: Completed
• Trial end date: 2004-02-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Mometasone Furoate

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.