Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05529)

Allergic Rhinitis Clinical Trial

Official title:

Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00732381
• Other study ID #: P05529
• Status: Completed
• Phase: Phase 3
• Start date: August 2008
• Est. completion date: November 2008

Study information

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

Clinical Trial Summary

This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• A subject must be 12 years of age or older, of either sex, and of any race.

• A subject must have at least a 2-year history of SAR which exacerbates during the study season.

• A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1.

• A subject must be clinically symptomatic at the Screening and Baseline Visits.

Exclusion Criteria:

• A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.

• A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit.

• A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.

• A subject who is participating in any other clinical study.

• A subject who is part of the staff personnel directly involved with this study.

• A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.

• A female subject who is breast-feeding, pregnant, or intends to become pregnant.

• A subject previously randomized into this study.

• A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal

Intervention

Drug:
• Mometasone furoate nasal spray (MFNS)
MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days
• Matching placebo nasal spray
Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

Meltzer EO, Shekar T, Teper AA. Mometasone furoate nasal spray for moderate-to-severe nasal congestion in subjects with seasonal allergic rhinitis. Allergy Asthma Proc. 2011 Mar-Apr;32(2):159-67. doi: 10.2500/aap.2011.32.3424. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days	Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe symptoms. PRIOR (the subject's status over the previous 12 hours [reflective])	15 days of treatment
Secondary	The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days	Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. PRIOR (the subject's status over the previous 12 hours [reflective])	15 days of treatment