Clinical trial NCT00783237: Onset of Effect of Mometasone Nasal Spray in Induced Allergic Rhinitis (Study P03431)
Official title: Onset of Action of Mometasone Furoate Nasal Spray vs. Placebo in Induced Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-10-31
Enrollment: 340
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Total Nasal Symptom Score (TNSS)
timeFrame: On the day of treatment, after 90 and 120 minutes of pollen exposure and every 60 minutes post-dose for 12 hours
Secondary outcomes:
measure: Nasal and Non-Nasal symptoms, Total Nasal and Total Non-Nasal symptoms, Total Symptom Score, Global Therapeutic Response
timeFrame: On the day of treatment, after 90 and 120 minutes of pollen exposure and every 60 minutes post-dose for 12 hours
Other outcomes:
Locations:
Study officials:
References:
citation: Berger WE, Nayak AS, Staudinger HW. Mometasone furoate improves congestion in patients with moderate-to-severe seasonal allergic rhinitis. Ann Pharmacother. 2005 Dec;39(12):1984-9. doi: 10.1345/aph.1G202. Epub 2005 Nov 8.