Clinical trial NCT02125253: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Amneal Pharmaceuticals, LLC
Sponsor class: INDUSTRY
Collaborators: name: Novum Pharmaceutical Research Services
First posted: 2014-04-29
Enrollment: 811
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* The patient has had recent exposure (30 days) or was at risk of being exposed to chicken pox or measles.
* Patients with any untreated fungal, bacterial, systemic viral infections within the previous 30 days.
* Use of any ophthalmic steroids within 14 days or nasal, inhaled or systemic steroids within 30 days of the study start.
* Use of the reference product, Nasonex® within 3 months of the study start.
* Use of intranasal or systemic second-generation anti-histamines within10 days of enrollment.
* Use of intranasal cromolyn within 14 days of enrollment.
* Use of intranasal or systemic first-generation anti-histamines, leukotriene receptor antagonists or other nasal decongestants within 3 days of enrollment.
* Use of any tricyclic anti-depressant within 30 days of enrollment
* Patients with attention-deficit disorder being treated with methylphenidate containing products that have not been on a stable dosing regimen for at least the 30 previous days and who cannot remain on the same dosing regimen throughout the study.
* Desensitization therapy to the seasonal allergen that is causing the patients allergic rhinitis within the previous 6 months.
* Previous SAR and/or PAR that has proven unresponsive to steroid therapy.
* Any known hypersensitivity to mometasone, other steroids or any of the components of the study nasal spray.
* Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition that in the Investigator's opinion would place the study patient at undue risk by participating or could jeopardize the integrity of the study evaluations.
* Receipt of any drug as part of a research study within 30 days prior to the first placebo lead-in dose.
* Planned travel outside of the local area for more than 2 consecutive days or 3 days in total, during the patient's participation in the study.
* Previous participation in this study.
* The patient currently smokes cigarettes, cigars, and/or pipes and is a heavy smoker
* The patient shares a household with another patient currently enrolled in this study

Primary outcomes:
measure: Change from Baseline rTNSS
timeFrame: Days 1 - 14
measure: Total Nasal Symptom Score (TNSS)
timeFrame: Days 1 - 14
Secondary outcomes:
measure: Change in Baseline iTNSS
timeFrame: Days 1 - 14
Other outcomes:
Locations:
city: Austin
country: United States
facility: Isis Clinical Research
state: Texas
city: Austin
country: United States
facility: Austin Clinical Research
state: Texas
city: Austin
country: United States
facility: Sirius Clinical Research
state: Texas
city: Kerrville
country: United States
facility: Kerrville Research Associates
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Antonio
country: United States
facility: Allergy & Asthma Research Center
state: Texas
city: San Antonio
country: United States
facility: Biogenics Research Institute
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: San Antonio
country: United States
facility: Sylvania Research
state: Texas
city: Waco
country: United States
facility: Allergy & Asthma Care of Waco
state: Texas
Study officials:
affiliation: Novum Pharmaceutical Reserach Services
name: Keith Gallicano, PhD
role: STUDY_CHAIR
References: