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

Allergic Rhinitis Clinical Trial

Official title:

Onset of Action of Mometasone Furoate Nasal Spray vs. Placebo in Induced Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00783237
• Other study ID #: P03431
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2003
• Est. completion date: February 21, 2004

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 340
• Est. completion date: February 21, 2004
• Est. primary completion date: February 21, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Mometasone
Mometasone Furoate Nasal Spray, single dose of 200 mcg (2 sprays per nostril)
• Placebo
Placebo nasal spray, single dose of 2 sprays per nostril

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & 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. Epub 2005 Nov 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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