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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.
Information provided by (Responsible Party):
Sandoz Identifier:
First received: December 22, 2009
Last updated: March 27, 2017
Last verified: March 2017
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: Quadruple (Participant, Care Provider, 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:

Primary Outcome Measures:
  • The mean change from baseline for mean rTNSS [ Time Frame: 2 weeks ]

Secondary Outcome Measures:
  • The mean change from baseline for mean iTNSS [ Time Frame: 2 weeks ]

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


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01038427

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
Sylvana Research
San Antonio, Texas, United States, 78229
San Antonio, Texas, United States, 78229
Waco, Texas, United States, 76708
Sponsors and Collaborators
  More Information

Responsible Party: Sandoz Identifier: NCT01038427     History of Changes
Other Study ID Numbers: 70947201
Study First Received: December 22, 2009
Last Updated: March 27, 2017

Keywords provided by Sandoz:
Mometasone Furoate

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Signs and Symptoms
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents processed this record on September 21, 2017