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

NCT ID: NCT00783237

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 340 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-01
• Study Completion Date: 2004-02-21

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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Mometasone Furoate Nasal Spray

Group Type: EXPERIMENTAL

Mometasone

Intervention Type: DRUG

Mometasone Furoate Nasal Spray, single dose of 200 mcg (2 sprays per nostril)

Placebo Nasal Spray

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo nasal spray, single dose of 2 sprays per nostril

Interventions

Mometasone

Mometasone Furoate Nasal Spray, single dose of 200 mcg (2 sprays per nostril)

Intervention Type: DRUG

Placebo

Placebo nasal spray, single dose of 2 sprays per nostril

Intervention Type: DRUG

Other Intervention Names

Nasonex, SCH 032088

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: RESULT

PMID: 16278257 (View on PubMed)

Other Identifiers

P03431

Identifier Type: -

Identifier Source: org_study_id