Phase 3
N=333
Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05583)
Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT00728416 ↗Enrolled (actual)
333
Serious AEs
0.0%
Results posted
Nov 2009
Primary outcome: Primary: Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days — -0.71; -0.40 Units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Mometasone furoate nasal spray (MFNS) (Drug); Matching placebo nasal spray (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days |
-0.71; -0.40 | <0.001 sig |
| SECONDARY Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days |
-3.00; -1.73 | <0.001 sig |
Summary
This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00728416). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.