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

NCT00783237 | Completed Phase 4

• 1 other identifier: P03431
• Study Type: interventional
• Target: 340
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Mometasone Furoate Nasal Spray

EXPERIMENTAL

Drug: Mometasone

Placebo Nasal Spray

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Mometasone DRUG

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

Also known as: Nasonex, SCH 032088

Mometasone Furoate Nasal Spray

Placebo DRUG

Placebo nasal spray, single dose of 2 sprays per nostril

Placebo Nasal Spray

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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.

  PMID: 16278257 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: October 30, 2008
• First Posted: October 31, 2008
• Study Start: December 1, 2003
• Primary Completion: February 21, 2004
• Study Completion: February 21, 2004
• Last Updated: August 15, 2024

Record last verified: 2022-02