Study to Compare the Therapeutic Equivalence of Mometasone Furoate Nasal Spray, 50 mcg With Nasonex Nasal Spray in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
A Blinded, Randomized, Placebo-Controlled, Parallel Group, Multi-Site Study to Compare the Therapeutic Equivalence of Mometasone Furoate Nasal Spray, 50 mcg (Amneal Pharmaceuticals LLC) With NASONEX® Nasal Spray (Schering Corporation) in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
1 other identifier
interventional
811
1 country
10
Brief Summary
To evaluate the therapeutic equivalence of the lest formulation of Mometasone Furoate Nasal Spray, 50 mcg to the marketed formulation NASONEX® (mometasone furoate monohydrate) Nasal Spray, 50 mcg/actuation in patients with seasonal allergic rhinitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2014
Shorter than P25 for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 25, 2014
CompletedFirst Posted
Study publicly available on registry
April 29, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedNovember 2, 2015
October 1, 2015
2 months
April 25, 2014
October 5, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Change from Baseline rTNSS
Change from baseline in average AM/PM reflective Total Nasal Symptom Score (rTNSS) over Days 1 to 14
Days 1 - 14
Total Nasal Symptom Score (TNSS)
The sum of patient-rated severity scores for four allergy symptoms : runny nose, nasal congestion, itchy nose, and sneezing based on a 4-point scale.
Days 1 - 14
Secondary Outcomes (1)
Change in Baseline iTNSS
Days 1 - 14
Study Arms (3)
Mometasone Furoate Nasal Spray, 50 mcg
EXPERIMENTALMometasone Furoate Nasal Spray, 50 mcg. 4 actuations per day for 14 days.
Nasonex Nasal Spray, 50 mcg
ACTIVE COMPARATORNasonex (mometasone furoate monohydrate) Nasal Spray, 50 mcg. 4 actuations per day for 14 days.
Placebo Nasal Spray
PLACEBO COMPARATORPlacebo of Mometasone Furoate Nasal Spray. 4 actuations per day for 14 days.
Interventions
a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate
a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate monohydrate
a metered-dose, manual pump spray unit containing an aqueous suspension
Eligibility Criteria
You may qualify if:
- If female and of child-bearing potential, have a negative urine pregnancy test and is prepared to abstain from sexual intercourse or use a reliable method of contraception during the study
- Documented positive allergic skin test, performed within the previous 12 months, to one or more of the allergens in season at the time the study is being conducted.
- A minimum of two consecutive years of previous history of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.
- A score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) and a minimum score of at least 2 for "nasal congestion" and a minimum score of at least 2 for one of the remaining 3 symptoms representing the 12hours prior to the screening visit.
- An average composite score of at least 6 on the rTNSS and a minimum score of at least 2 for "nasal congestion" and a minimum score of at least 2 for one of the remaining 3 symptoms representing the last 3 days of the 7-day placebo lead-in period before the randomization visit and the morning of the first day.
- of the randomization visit.
You may not qualify if:
- Females who are pregnant, lactating or likely to become pregnant during the study.
- Negative or lack of documented skin allergen test (performed within the previous 12 months) to at least one of the allergens in season at the time the study is being conducted.
- Patients who suffer from chronic signs and symptoms of Perennial Allergic Rhinitis, unless the investigator assesses that the patient's current signs and symptoms are a clear exacerbation of Seasonal Allergic Rhinitis (SAR) rather than chronic PAR.
- Patients who suffer only from perennial allergic rhinitis or seasonal allergic rhinitis to a different allergen than that in season at the time the study is conducted.
- Previous history of less than 2 years of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted.
- Any patient who meets the minimum rTNSS requirements at the start of the placebo lead-in period but no longer meets the requirements prior to the randomized active treatment period of the study cannot continue in the active treatment period.
- History of asthma over the previous two years that required chronic therapy. Occasional acute or mild exercise induced asthma will be allowable on the condition that the treatment of the attacks is restricted to beta-agonists only.
- Patients with nasal conditions, including infectious rhinitis, rhinitis medicamentosa or atrophic rhinitis.
- Clinically significant nasal deformity or any recent nasal surgery or trauma that has not completely healed.
- Sinus infection within the previous 30 days or history of reoccurring sinus infections.
- Patient has started immunotherapy or changed their dose of immunotherapy within 30 days of the first placebo lead-in dose or is likely to have to start immunotherapy, or change their current dose during the study.
- Treatment for oral Candidiasis within 30 days of starting the study or a current oral Candidiasis infection.
- Upper respiratory tract infection within the previous 30 days.
- Patients with a history of tuberculosis.
- Patients with the presence of glaucoma, cataracts, ocular herpes simplex, conjunctivitis or other eye infection not related to the diagnosis of SAR within 14 days of enrollment.
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Isis Clinical Research
Austin, Texas, 78731, United States
Austin Clinical Research
Austin, Texas, 78750, United States
Sirius Clinical Research
Austin, Texas, 78759, United States
Kerrville Research Associates
Kerrville, Texas, 78028, United States
Central Texas Health Research
New Braunfels, Texas, 78130, United States
Allergy & Asthma Research Center
San Antonio, Texas, 78229, United States
Biogenics Research Institute
San Antonio, Texas, 78229, United States
Diagnostics Research Group
San Antonio, Texas, 78229, United States
Sylvania Research
San Antonio, Texas, 78229, United States
Allergy & Asthma Care of Waco
Waco, Texas, 76708, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Keith Gallicano, PhD
Novum Pharmaceutical Reserach Services
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2014
First Posted
April 29, 2014
Study Start
January 1, 2014
Primary Completion
March 1, 2014
Study Completion
June 1, 2014
Last Updated
November 2, 2015
Record last verified: 2015-10