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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sandoz Inc.
ClinicalTrials.gov Identifier:
NCT01038427
First received: December 22, 2009
Last updated: December 14, 2012
Last verified: December 2012
  Purpose

This study will compare the safety and efficacy 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 will be tested for superiority against a placebo nasal spray.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: Mometasone Furoate
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sandoz Inc.:

Primary Outcome Measures:
  • The mean change from baseline for mean rTNSS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The mean change from baseline for mean iTNSS [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 1103
Study Start Date: December 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mometasone Furoate Nasal Spray (Lek d.d.) Drug: Mometasone Furoate
Test product - 200 mcg per day
Active Comparator: Nasonex® Nasal Spray Drug: Mometasone Furoate
Reference listed drug - 200 mcg per day
Placebo Comparator: Placebo Nasal Spray Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038427

Locations
United States, Texas
Austin, Texas, United States, 78731/50/59
Kerrville, Texas, United States, 78028
Live Oak, Texas, United States, 78233
New Braunfels, Texas, United States, 78310
San Antonio, Texas, United States, 78229
Sylvana Research
San Antonio, Texas, United States, 78229
Waco, Texas, United States, 76708
Sponsors and Collaborators
Sandoz Inc.
  More Information

No publications provided

Responsible Party: Sandoz Inc.
ClinicalTrials.gov Identifier: NCT01038427     History of Changes
Other Study ID Numbers: 70947201
Study First Received: December 22, 2009
Last Updated: December 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Sandoz Inc.:
Rhinitis
Allergic
Seasonal
Mometasone Furoate
Equivalence

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Signs and Symptoms
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Mometasone furoate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 26, 2014