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

NCT01038427 | Completed Phase 3 Results

• 1 other identifier: 70947201
• Study Type: interventional
• Target: 795
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Rhinitis, Allergic, Seasonal

Keywords

Rhinitis; Seasonal Allergic Rhinitis; Mometasone Furoate; Equivalence; Hay fever

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Equivalence: Per-Protocol Population)

  Baseline, 14 days

• Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (iTNSS) (Superiority: Intent-to-Treat Population)

  Baseline, 14 days

• Clinical Global Improvement Based on the Investigator's Assessment

  Day 15

• Clinical Global Improvement Based on the Patient's Assessment

  Day 15

Study Arms (3)

Test

EXPERIMENTAL

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)

Reference

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

Placebo nasal spray administered once daily for 14 days.

Drug: Placebo

Interventions

Mometasone furoate 50 mcg/actuation nasal spray (Lek Pharmaceuticals) DRUG

Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.

Test

Mometasone furoate (Nasonex®) 50 mcg/actuation nasal spray DRUG

Mometasone nasal spray administered once daily at a dose of 200 mcg (4 actuations) for 14 days.

Reference

Placebo DRUG

Placebo nasal spray administered once daily (4 actuations) for 14 days.

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sandoz: lead

Study Sites (8)

Unknown Facility

Austin, Texas, 78731, United States

Location

Unknown Facility

Austin, Texas, 78759, United States

Location

Unknown Facility

Kerrville, Texas, 78028, United States

Location

Unknown Facility

Live Oak, Texas, 78233, United States

Location

Unknown Facility

New Braunfels, Texas, 78310, United States

Location

Sylvana Research

San Antonio, Texas, 78229, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

Unknown Facility

Waco, Texas, 76708, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Rhinitis

Interventions

Mometasone Furoate

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

Novartis.email@novartis.com

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2009
• First Posted: December 24, 2009
• Study Start: December 2, 2009
• Primary Completion: February 16, 2010
• Study Completion: February 16, 2010
• Last Updated: February 3, 2021
• Results First Posted: February 3, 2021

Record last verified: 2021-01

Locations

US (8)