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

Completed · Phase 3 · Has a placebo group

Conditions studied: Seasonal Allergic Rhinitis

In brief

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.

Key facts

Study ID: NCT02230696
Run by: Padagis LLC
People needed: 951
Starts: 2014-08-01
Expected to finish: 2015-02-01
Last updated by the study team: 2021-10-22

Who can join

Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Complete the informed consent/assent process.
Male or female between 12 to 65 years of age, inclusive.
Females of childbearing potential willing to use an acceptable form of birth control during the study.
Moderate-to-severe allergic rhinitis.
At Visits 1 and 2 have instantaneous and reflective symptom scores sufficient enough to qualify for continued participation in the study
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.
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.
Subject must be willing and able to understand and comply with the requirements of the study

You may not qualify if…

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.
Subject has a history of hypersensitivity or allergy to any ingredient in the drug products.
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.
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.
Subject has asthma or a history of asthma requiring chronic treatment within two years of Visit 1.
Treatment for oral Candidiasis within 30 days of starting the study, or a current oral Candidiasis infection.
Subject has had recent exposure (30 days) or is at risk of being exposed to chicken pox or measles.
Subjects with any untreated fungal, bacterial, systemic viral infections within the previous 30 days.
Use of various therapies within the given time period prior to Visit 1 and throughout the study.
Initiation of hormone replacement therapy during the study.
Initiation of immunotherapy during the study, or changes in dosage or frequency of immunotherapy within the 30 days preceding Visit 1.
Subject has received immune-system therapy or peptide immunotherapy of any form.
Subject had desensitization therapy to the seasonal allergen that is causing their allergic rhinitis within the previous 6 months.
Subject presented with conjunctivitis or any other eye signs/symptoms that are not related to the diagnosis of SAR.
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.
Subjects being treated with a product containing a sympathomimetic agent.
Subject has previously enrolled in this study or is enrolled in this study with another participating investigator site.
Subject is concurrently participating in another investigational study or using any investigational drug (or biologic) or device.
Subject plans or anticipates travel outside the local allergen area at any point in the study.
History of unresponsiveness to steroid nasal sprays for SAR symptoms.
Employee (or employee's family member) of the research center or private practice.
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

Where it is running

Atlanta Allergy & Asthma Clinic, PA — Stockbridge, Georgia, United States
Clinical Research Atlanta (CRA) — Stockbridge, Georgia, United States
Family Allergy and Asthma Research Institute — Louisville, Kentucky, United States
Chesapeake Clinical Research, Inc. — Baltimore, Maryland, United States
NEMRA Northeast Medical Research Associates, Inc — North Dartmouth, Massachusetts, United States
Clinical Research Institute, Inc. — Minneapolis, Minnesota, United States
Clinical Research Institute LLC — Minneapolis, Minnesota, United States
Clinical Research of the Ozarks, Inc. — Columbia, Missouri, United States
Clinical Research of the Ozarks, Inc. — Rolla, Missouri, United States
The Clinical Research Center, LLC — St Louis, Missouri, United States
Princeton Center for Clinical Research — Skillman, New Jersey, United States
Island Medical Research, P.C. — Rockville Centre, New York, United States
Allergy and Asthma Center of NC — High Point, North Carolina, United States
North Carolina Clinical Research — Raleigh, North Carolina, United States
Toledo Center for Clinical Research — Sylvania, Ohio, United States
Allergy, Asthma & Clinical Research Center — Oklahoma City, Oklahoma, United States
Vital Prospects Clinical Research Institute, P.C. — Tulsa, Oklahoma, United States
National Allergy, Asthma & Urticaria Centers of Charleston — North Charleston, South Carolina, United States
New Phase Research and Development — Knoxville, Tennessee, United States
ISIS Clinical Research, LLC — Austin, Texas, United States
Sirius Clinical Research LLC — Austin, Texas, United States
AARA Research Center — Dallas, Texas, United States
Pharmaceutical Research & Consulting Inc. — Dallas, Texas, United States
Western Sky Medical Research — El Paso, Texas, United States
Central Texas Health Research — New Braunfels, Texas, United States

Full record on ClinicalTrials.gov

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