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Comparative Safety and Efficacy of Two Steroid Treatments in the Relief of the Symptoms of Seasonal Allergic Rhinitis

Information source: Perrigo Company
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Seasonal Allergic Rhinitis

Intervention: Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray (Drug); Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray (Drug); Placebo nasal spray (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Perrigo Company

Summary

To compare safety and efficacy of Perrigo's steroid drug product compared with an FDA approved steroid drug product in the treatment of subjects with seasonal allergic rhinitis.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Mean Change from Baseline for mean reflective Total Nasal Symptom Score (rTNSS)

Secondary outcome:

Mean Change from Baseline in the mean Instantaneous Total Nasal Symptom Score (iTNSS)

Initial onset of action

Eligibility

Minimum age: 12 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Complete the informed consent/assent process. 2. Male or female between 12 to 65 years of age, inclusive. 3. Females of childbearing potential willing to use an acceptable form of birth control during the study. 4. Moderate-to-severe allergic rhinitis. 5. At Visits 1 and 2 have instantaneous and reflective symptom scores sufficient enough to qualify for continued participation in the study 6. Subject must have a history (for 2 or more seasons) of seasonal allergy to at least one allergen known to be present during the study season. 7. Subject must be in general good health with no clinically significant disease or medical procedure other than allergic rhinitis within various time periods prior to Visit 1. 8. Subject must be willing and able to understand and comply with the requirements of the study Exclusion Criteria: 1. Female who is pregnant or nursing, who is not using or does not agree to use an acceptable form of contraception during the study, or who intends to become pregnant during the study. 2. Subject has a history of hypersensitivity or allergy to any ingredient in the drug products. 3. Subject has any condition or abnormality of the upper airway that, in the opinion of the Investigator, could interfere with administration of the product, evaluation of the subject's condition, or other aspect of the trial. 4. The presence of any nasal mucosal crusting, erosion, ulceration, nasal septum perforation, or any kind of blockage of the nasal passages at screening or randomization. 5. Subject has asthma or a history of asthma requiring chronic treatment within two years of Visit 1. 6. Treatment for oral Candidiasis within 30 days of starting the study, or a current oral Candidiasis infection. 7. Subject has had recent exposure (30 days) or is at risk of being exposed to chicken pox or measles. 8. Subjects with any untreated fungal, bacterial, systemic viral infections within the previous 30 days. 9. Use of various therapies within the given time period prior to Visit 1 and throughout the study. 10. Initiation of hormone replacement therapy during the study. 11. Initiation of immunotherapy during the study, or changes in dosage or frequency of immunotherapy within the 30 days preceding Visit 1. 12. Subject has received immune-system therapy or peptide immunotherapy of any form. 13. Subject had desensitization therapy to the seasonal allergen that is causing their allergic rhinitis within the previous 6 months. 14. Subject presented with conjunctivitis or any other eye signs/symptoms that are not related to the diagnosis of SAR. 15. Clinically relevant abnormal physical findings or medication use within 1 week of randomization, which, in the opinion of the investigator, might interfere with the conduct or results of the study or place the prospective subject at increased risk. 16. Subjects being treated with a product containing a sympathomimetic agent. 17. Subject has previously enrolled in this study or is enrolled in this study with another participating investigator site. 18. Subject is concurrently participating in another investigational study or using any investigational drug (or biologic) or device. 19. Subject plans or anticipates travel outside the local allergen area at any point in the study. 20. History of unresponsiveness to steroid nasal sprays for SAR symptoms. 21. Employee (or employee's family member) of the research center or private practice. 22. If the subject has a smoking history of greater than 10 pack years or has recently started or re-started smoking within the past 2 years

Locations and Contacts

Atlanta Allergy & Asthma Clinic, PA, Stockbridge, Georgia 30281, United States

Clinical Research Atlanta (CRA), Stockbridge, Georgia 30281, United States

Family Allergy and Asthma Research Institute, Louisville, Kentucky 40215, United States

Chesapeake Clinical Research, Inc., Baltimore, Maryland 21236, United States

NEMRA Northeast Medical Research Associates, Inc, North Dartmouth, Massachusetts 02747, United States

Clinical Research Institute LLC, Minneapolis, Minnesota 63141, United States

Clinical Research Institute, Inc., Minneapolis, Minnesota 55402, United States

Clinical Research of the Ozarks, Inc., Columbia, Missouri 65203, United States

Clinical Research of the Ozarks, Inc., Rolla, Missouri 65401, United States

The Clinical Research Center, LLC, Saint Louis, Missouri 63141, United States

Princeton Center for Clinical Research, Skillman, New Jersey 08558, United States

Island Medical Research, P.C., Rockville Centre, New York 11570, United States

Allergy and Asthma Center of NC, High Point, North Carolina 27262, United States

North Carolina Clinical Research, Raleigh, North Carolina 27607, United States

Toledo Center for Clinical Research, Sylvania, Ohio 43560, United States

Allergy, Asthma & Clinical Research Center, Oklahoma City, Oklahoma 73120, United States

Vital Prospects Clinical Research Institute, P.C., Tulsa, Oklahoma 74136, United States

National Allergy, Asthma & Urticaria Centers of Charleston, N. Charleston, South Carolina 29420, United States

New Phase Research and Development, Knoxville, Tennessee 37919, United States

ISIS Clinical Research, LLC, Austin, Texas 78731, United States

Sirius Clinical Research LLC, Austin, Texas 78759, United States

AARA Research Center, Dallas, Texas 75231, United States

Pharmaceutical Research & Consulting Inc., Dallas, Texas 75231, United States

Western Sky Medical Research, El Paso, Texas 79904, United States

Central Texas Health Research, New Braunfels, Texas 78130, United States

Diagnostics Research Group, San Antonio, Texas 78229, United States

Quality Research Inc., San Antonio, Texas 78209, United States

Sylvana Research Associates, San Antonio, Texas 78257, United States

Allergy Asthma Research Institute, Waco, Texas 76712, United States

The Asthma & Allergy Center - Bellevue, Bellevue, Washington 68123, United States

Additional Information

Starting date: August 2014
Last updated: July 1, 2015

Page last updated: August 23, 2015

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