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

Organon

Status and phase

Completed

Phase 4

Conditions

Allergic Rhinitis

Treatments

Drug: Placebo

Drug: Mometasone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00783237

P03431

Details and patient eligibility

About

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.

Enrollment

340 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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.