Last updated: January 14, 2021
Sponsor: Sandoz
Overall Status: Completed
Phase
3
Condition
Allergy
Common Cold
Nasal Obstruction
Treatment
N/AClinical Study ID
NCT01038427
70947201
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 inseason at the time the study is being conducted.
- Signed informed consent form. For patients under the age of majority the parent orlegal guardian should sign the consent form and the child will be required to sign apatient "assent" form.
- Documented positive allergic skin test to local pollen, performed within the past 12months.
- A score of at least 6 on the reflective Total Nasal Symptom Score (rTNSS) with aminimum score of at least 2 for "nasal congestion" and a minimum score of at least 2for one of the remaining 3 symptoms.
Exclusion
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 theexception of occasional acute or mild exercise induced asthma).
- Patients with some nasal conditions, or with clinically significant nasal deformity orany recent nasal surgery or trauma that has not completely healed.
- Upper respiratory tract infection or any untreated infections within the previous 30days.
- Patient has started immunotherapy/changed the dose within 30 days of starting thestudy or has desensitization therapy to the seasonal allergen that is causing theallergic 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 thediagnosis of seasonal allergic rhinitis within 14 days of enrollment.
- The patient has had recent exposure (30 days) or was at risk of being exposed tochicken pox or measles.
- Any known hypersensitivity to mometasone, other steroids or any of the components ofthe study nasal spray.
- Planned travel outside of the local area for more than 2 consecutive days or 3 days intotal.
- The patient has a history of alcohol or drug abuse.
Study Design
Total Participants: 795
Study Start date:
December 02, 2009
Estimated Completion Date:
February 16, 2010
Study Description
Connect with a study center
Austin, Texas 78759
United StatesSite Not Available
Kerrville, Texas 78028
United StatesSite Not Available
Live Oak, Texas 78233
United StatesSite Not Available
New Braunfels, Texas 78310
United StatesSite Not Available
Sylvana Research
San Antonio, Texas 78229
United StatesSite Not Available
San Antonio, Texas 78229
United StatesSite Not Available
Waco, Texas 76708
United StatesSite Not Available
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