A Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis (Study P04512)
This study has been completed.
Merck Sharp & Dohme Corp.
First Posted: October 31, 2008
Last Update Posted: May 20, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
This study was conducted to see if mometasone nasal spray is efficaceous for the treatment of perennial allergic rhinitis. Patients will be randomized to active mometasone, placebo mometasone, active fluticasone, or placebo fluticasone.
|Perennial Allergic Rhinitis||Drug: Placebo for MF Drug: Placebo for FP Drug: Mometasone Drug: Fluticasone||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
|Official Title:||Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis|
Resource links provided by NLM:
Drug Information available for: Fluticasone propionate Mometasone furoate Fluticasone Mometasone furoate monohydrate Fluticasone furoateU.S. FDA Resources
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks [ Time Frame: Baseline to 2 weeks of treatment ]The nasal symptoms (sneezing attacks, rhinorrhea, nasal congestion and itching) were rated in 4 grades (+++: 3 points, ++: 2 points, +: 1 point, -: 0 point) based on the evaluation criteria for nasal symptoms. Total possible best score is 0 points, total possible worst score is 12 points.
|Study Start Date:||September 2005|
|Study Completion Date:||December 2005|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
Placebo Comparator: Mometasone Furoate Placebo (PLAMF)
Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
Drug: Placebo for MF
Placebo to mometasone furoate nasal spray, indistinguishable from mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks
Placebo Comparator: Fluticasone Propionate Placebo (PLAFP)
Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
Drug: Placebo for FP
Placebo to fluticasone nasal spray, indistinguishable from fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks
Experimental: Mometasone Furoate (MF)
Mometasone furoate nasal spray 200 μg/day(QD)
Mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks
Active Comparator: Fluticasone Propionate (FP)
Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
Fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks
Other Name: Flonase
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