A Study Comparing the Clinical Equivalence of Two Mometasone Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

Study Overview
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Brief Summary
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This study compared the efficacy and safety of a generic mometasone nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations were tested for superiority against a placebo nasal spray.

Detailed Description
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The study was designed as a double-blind, randomized, placebo-controlled, parallel group, multi-site to compare the clinical equivalence of the test formulation of mometasone furoate monohydrate, 50 mcg/actuation nasal spray (Lek Pharmaceuticals d.d.) with the reference formulation Nasonex® nasal spray (Schering) in the relief of the signs and symptoms of seasonal allergic rhinitis. Participants who met the inclusion/exclusion criteria entered a 7-day placebo lead-in period. Following this placebo lead-in period, on Day 1 participants who continued to meet eligibility criteria were randomly assigned in a 2:2:1 ratio to one of three treatment groups (Test Product:Reference Product:Placebo) for 14 days of treatment. In all treatment groups, participants were instructed to administer the study drug once daily at approximately the same time each day. A single dose of 200 mcg was 4 actuations, each containing 50 mcg per actuation. Patients were instructed to administer the 4 actuations alternating between right and left nostril, such that 2 actuations were not administered back to back to the same nostril.

Official Title
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A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi-Site Study to Compare the Clinical Equivalence of Mometasone Nasal Spray (Lek Pharmaceuticals) With NASONEX® Nasal Spray (Schering Corporation) in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

Conditions
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Rhinitis, Allergic, Seasonal

Intervention / Treatment
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* Drug: Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals)
* Drug: Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant, non-lactating female 12 years of age or older with a minimum of 2 years of previous history of seasonal allergic rhinitis to the pollen/allergen in season at the time the study is being conducted. Signed informed consent form. For patients under the age of majority the parent or legal guardian should sign the consent form and the child will be required to sign a patient assent form. Documented positive allergic skin test to local pollen, performed within the past 12 months. A score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) with 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. Exclusion Criteria: Females who are pregnant, lactating or likely to become pregnant during the study. History of asthma over the previous two years that required chronic therapy (with the exception of occasional acute or mild exercise induced asthma). Patients with some nasal conditions, or with clinically significant nasal deformity or any recent nasal surgery or trauma that has not completely healed. Upper respiratory tract infection or any untreated infections within the previous 30 days. Patient has started immunotherapy/changed the dose within 30 days of starting the study or has desensitization therapy to the seasonal allergen that is causing the allergic rhinitis within the previous 6 months. Patients with a history of tuberculosis, or with the presence of glaucoma, cataracts, ocular herpes simplex, conjunctivitis or other eye infection not related to the diagnosis of seasonal allergic rhinitis 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. Any known hypersensitivity to mometasone, other steroids or any of the components of the study nasal spray. Planned travel outside of the local area for more than 2 consecutive days or 3 days in total. The patient has a history of alcohol or drug abuse.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test<br>Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) administered once daily at a dose of 200 mcg (4 actuations) for 14 days. | Drug: Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals)<br>* Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.<br>|
| Active Comparator: Reference<br>Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days. | Drug: Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray<br>* Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.<br>|
| Placebo Comparator: Placebo<br>Placebo nasal spray administered once daily for 14 days. | Drug: Placebo<br>* Placebo nasal spray administered once daily (4 actuations) for 14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Equivalence: Per-Protocol Population) | Patients were required to record a 12 hour reflective score twice a day approximately 12 hours apart. For the rTNSS patients were asked to look back or reflect on their severity of nasal symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms. Mean baseline rTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period. Mean change from baseline was calculated as mean baseline rTNSS - mean post-randomization rTNSS. A positive change from baseline in rTNSS is considered a favorable outcome. | Baseline, 14 days | 
| Mean Change From Baseline in Reflective Total Nasal Symptom Score (rTNSS) (Superiority: Intent-to-Treat Population) | Patients were required to record a 12 hour reflective score twice a day approximately 12 hours apart. For the rTNSS patients were asked to look back or reflect on their severity of nasal symptoms over the previous 12 hours. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean rTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms. Mean baseline rTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period. Mean change from baseline was calculated as mean baseline rTNSS - mean post-randomization rTNSS. A positive change from baseline in rTNSS is considered a favorable outcome. | Baseline, 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Equivalence: Per-Protocol Population) | Patients were required to record an instantaneous score twice a day approximately 12 hours apart. For the iTNSS patients were asked to evaluate how I feel now regarding their severity of nasal symptoms. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean iTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms. Mean baseline iTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period. Mean change from baseline was calculated as mean baseline iTNSS - mean post-randomization iTNSS. A positive change from baseline in iTNSS is considered a favorable outcome. | Baseline, 14 days | 
| Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Superiority: Intent-to-Treat Population) | Patients were required to record an instantaneous score twice a day approximately 12 hours apart. For the iTNSS patients were asked to evaluate how I feel now regarding their severity of nasal symptoms. The first rating on each day was taken prior to dosing. Patients were asked to score 4 nasal symptoms (nasal congestion, runny nose, sneezing and itchy nose) on a 4 point scale ranging from 0 (no symptom) to 3 (severe symptom). The means of the 4 individual symptom scores obtained over the randomized treatment period were summed to give the mean iTNSS, which ranged from 0 to 12 with a lower score indicating less severe symptoms. Mean baseline iTNSS was calculated by summing the means of the 4 individual symptom scores obtained over the 72 hours before the randomized treatment period. Mean change from baseline was calculated as mean baseline iTNSS - mean post-randomization iTNSS. A positive change from baseline in iTNSS is considered a favorable outcome. | Baseline, 14 days | 
| Clinical Global Improvement Based on the Investigator's Assessment | A global evaluation of efficacy relative to baseline was assessed separately by the investigator and the patient on Day 15. Both the investigator and the patient were asked to rate clinical improvement since baseline on a 5-category scale ranging from No Relief to Complete Relief of signs and symptoms of seasonal allergic rhinitis. This record shows the clinical global improvement based on the investigator's assessment. | Day 15 | 
| Clinical Global Improvement Based on the Patient's Assessment | A global evaluation of efficacy relative to baseline was assessed separately by the investigator and the patient on Day 15. Both the investigator and the patient were asked to rate clinical improvement since baseline on a 5-category scale ranging from No Relief to Complete Relief of signs and symptoms of seasonal allergic rhinitis. This record shows the clinical global improvement based on the patient's assessment. | Day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rhinitis, Seasonal Allergic Rhinitis, Mometasone Furoate, Equivalence, Hay fever