Clinical Equivalence Study of Mometasone Nasal Spray

NCT01850823 | Completed Phase 3 Results

• 1 other identifier: 71209805
• Study Type: interventional
• Target: 880
• Locations: 1 country
• Sites: 25

Brief Summary

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

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Average AM/PM Reflective Total Nasal Symptom Score (rTNSS) Over Days 1 to 14.

  The Total Nasal Symptom Score Scale was used. Patients rated each of the following four symptoms on a scale from 0 to 3 : Nasal Congestion, Runny Nose, Sneezing, and Itchy Nose. Measurements were taken twice daily approximately 12 hours apart. 0= No symptom 1. Mild symptoms (sign/symptom present, minimal awareness, easily tolerated) 2. Moderate symptom (definite awareness of sign/symptom, bothersome but tolerable) 3. Severe symptom (sign/symptom hard to tolerate, causes interference with daily activities and/or sleeping)

  Twice daily from Baseline to 2 weeks

• Superiority of Active Treatment Arms Over Placebo

  Superiority analysis of Change From Baseline in rTNSS for both active arms compared to placebo arm. The Total Nasal Symptom Score Scale was used. Patients rated each of the following four symptoms on a scale from 0 to 3: Nasal Congestion, Runny Nose, Sneezing, and Itchy Nose twice daily approximately 12 hours apart. 0= No symptom 1. Mild symptoms (sign/symptom present, minimal awareness, easily tolerated) 2. Moderate symptom (definite awareness of sign/symptom, bothersome but tolerable) 3. Severe symptom (sign/symptom hard to tolerate, causes interference with daily activities and/or sleeping)

  Twice daily from Baseline to 2 weeks

Study Arms (3)

placebo

PLACEBO COMPARATOR

Placebo

Drug: placebo

NASONEX® Nasal Spray (Schering Corporation)

ACTIVE COMPARATOR

Mometasone Nasal spray

Drug: Mometasone Nasal Spray

Mometasone Nasal Spray (Watson Laboratories, Inc)

EXPERIMENTAL

Mometasone Nasal spray

Drug: Mometasone nasal spray

Interventions

placebo DRUG

placebo

Mometasone nasal spray DRUG

NASONEX® Nasal Spray (Schering Corporation)

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
• years of age or older
• Signed informed consent form, which meets all criteria of current FDA regulations. For patients under the age of majority in the state the study is being conducted (18 years in most states) the parent or legal guardian should sign the consent form and the child will be required to sign a patient "assent" form that will be written in such a way as to be understandable to a child.
• 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 (e.g., condom with spermicide, IUD, oral, injected, transdermal or implanted hormonal contraceptives). In order for hormonal birth control to be considered a reliable method the patient must have been on their regimen for at least 28 days.
• 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 (see Appendix A) representing the 12 hours prior to the screening visit.
• An average composite 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 (see Appendix A) representing the last 3 days of the 7-day placebo run-in period before the randomization visit and the morning of the first day of the randomization visit.

You may not qualify if:

• Under 12 years of age.
• 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. The results of all positive skin allergen test results should be reported.
• Patients who suffer from chronic signs and symptoms of Perennial Allergic Rhinitis (PAR) should be excluded from the study 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.
• A total score of less than 6 on the reflective Total Nasal Symptom Score (rTNSS) or a score less than 2 for "nasal congestion" or a score less than 2 for all 3 of the remaining symptoms (see Appendix A). 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 (e.g. significantly deformed septum, nasal polyps or ulcers) or any recent nasal surgery or trauma that has not completely healed.
• Sinus infection within the previous 30 days or history of re-occurring sinus infections.
• Patient has started immunotherapy (including topical or desensitization therapy) 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.

Sponsors & Collaborators

• Actavis Inc.: lead
• Watson Laboratories, Inc.: collaborator

Study Sites (25)

Investigator site 18

Stockbridge, Georgia, United States

Location

Investigator site 1

Louisville, Kentucky, United States

Location

Investigator site 3

Bethesda, Maryland, United States

Location

Investigator Site 19

Minneapolis, Minnesota, United States

Location

Investigator Site 24

St Louis, Missouri, United States

Location

Investigator site 22

Bellevue, Nebraska, United States

Location

Investigator Site 23

Skillman, New Jersey, United States

Location

Investigator site 2

Corning, New York, United States

Location

Investigator site 9

High Point, North Carolina, United States

Location

Investigator site 20

Raleigh, North Carolina, United States

Location

Investigator site 25

Cincinnati, Ohio, United States

Location

Investigator site 21

Sylvania, Ohio, United States

Location

Investigator site 16

Spartanburg, South Carolina, United States

Location

Investigator Site 10

Austin, Texas, United States

Location

Investigator Site 12

Austin, Texas, United States

Location

Investigator site 6

Austin, Texas, United States

Location

Investigator Site 11

Kerrville, Texas, United States

Location

Investigator Site 7

New Braunfels, Texas, United States

Location

Investigator Site 13

San Antonio, Texas, United States

Location

Investigator site 14

San Antonio, Texas, United States

Location

Investigator site 5

San Antonio, Texas, United States

Location

Investigator site 8

San Antonio, Texas, United States

Location

Investigator site 4

Waco, Texas, United States

Location

Investigator Site 15

Draper, Utah, United States

Location

Investigator Site 17

Greenfield, Wisconsin, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Director, PD/CE Studies
• Organization: Teva Pharmaceuticals Inc., USA

usmedinfo@tevapharm.com

1-888-483-8279

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: May 6, 2013
• First Posted: May 10, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 19, 2020
• Results First Posted: August 19, 2020

Record last verified: 2020-08

Locations

US (25)