Clinical Equivalence Study of Fluticasone Propionate Nasal Spray, 50 mcg/Actuation vs. Flonase in Allergic Rhinitis Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02246920|
Recruitment Status : Completed
First Posted : September 23, 2014
Last Update Posted : September 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Seasonal Allergic Rhinitis||Drug: Fluticasone propionate Drug: Flonase® Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Compare the Therapeutic Equivalence of Fluticasone Propionate Nasal Spray, 50 mcg With Flonase® Nasal Spray in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||September 2014|
Experimental: Investigational Test Product
Fluticasone propionate Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days
Drug: Fluticasone propionate
50 mcg/actuation Nasal Spray
Active Comparator: Reference Listed Drug
Flonase® (fluticasone propionate) Nasal Spray, 50 mcg/actuation; 200 mcg/day for 14 days
50 mcg/actuation Nasal Spray
Other Name: Fluticasone propionate (generic name)
Placebo Comparator: Placebo
Saline Placebo Nasal Spray; 4 total sprays/day for 14 days
Inactive Nasal Spray
- Change from baseline in average AM/PM reflective Total Nasal Symptom Score (rTNSS) over days 1 to 14. [ Time Frame: 2 week treatment period ]
Total Nasal Symptom Score (TNSS) is defined as the sum of the patient-rated severity scores for the following four allergy symptoms: Runny Nose, Nasal Congestion, Itchy Nose, and Sneezing. The severity score for each symptom will be based on a 4-point scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe).
The primary analysis for determining the therapeutic equivalence of the Test and Reference treatments will be based on each treatment's mean change from baseline for average rTNSS over the 2 week randomization treatment period.
The Per-Protocol Population (PPP) will be used for the primary analysis of bioequivalence.
- Change from baseline in average instantaneous Total Nasal Symptom Score (iTNSS) over days 1 to 14. [ Time Frame: 2 week treatment period ]
Secondary efficacy analysis will evaluate the mean change from baseline in average iTNSS over the 2 week randomization treatment period.
The Per-Protocol Population (PPP) will be used for the analysis of bioequivalence.
- Superiority to Placebo [ Time Frame: 2 week treatment period ]
The primary analysis for determining the superiority of each active treatment over placebo will be based on each treatment's mean change from baseline for average rTNSS over the 2 week randomization treatment period.
The modified Intent-to-Treat Population (mITT) will be used for the primary analysis of superiority.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246920
|United States, Pennsylvania|
|Novum Pharmaceutical Research Services|
|Pittsburgh, Pennsylvania, United States, 15206|