Clinical trial NCT02230696: Comparative Safety and Efficacy of Two Steroid Treatments in the Relief of the Symptoms of Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Padagis LLC
Sponsor class: INDUSTRY
First posted: 2014-09-03
Enrollment: 951
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Mean Change From Baseline for Mean Reflective Total Nasal Symptom Score (rTNSS)
timeFrame: Day 1 through Day 14
Secondary outcomes:
measure: Mean Change From Baseline in the Mean Instantaneous Total Nasal Symptom Score (iTNSS)
timeFrame: Day 1 through Day 14
measure: Change From Baseline iTNSS Scores on Day 1 Post First Randomized Dose
timeFrame: Day 1, up to four hours post the first dose
Other outcomes:
Locations:
city: Stockbridge
country: United States
facility: Atlanta Allergy & Asthma Clinic, PA
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta (CRA)
state: Georgia
city: Louisville
country: United States
facility: Family Allergy and Asthma Research Institute
state: Kentucky
city: Baltimore
country: United States
facility: Chesapeake Clinical Research, Inc.
state: Maryland
city: North Dartmouth
country: United States
facility: NEMRA Northeast Medical Research Associates, Inc
state: Massachusetts
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc.
state: Minnesota
city: Minneapolis
country: United States
facility: Clinical Research Institute LLC
state: Minnesota
city: Columbia
country: United States
facility: Clinical Research of the Ozarks, Inc.
state: Missouri
city: Rolla
country: United States
facility: Clinical Research of the Ozarks, Inc.
state: Missouri
city: Saint Louis
country: United States
facility: The Clinical Research Center, LLC
state: Missouri
city: Skillman
country: United States
facility: Princeton Center for Clinical Research
state: New Jersey
city: Rockville Centre
country: United States
facility: Island Medical Research, P.C.
state: New York
city: High Point
country: United States
facility: Allergy and Asthma Center of NC
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Sylvania
country: United States
facility: Toledo Center for Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma & Clinical Research Center
state: Oklahoma
city: Tulsa
country: United States
facility: Vital Prospects Clinical Research Institute, P.C.
state: Oklahoma
city: North Charleston
country: United States
facility: National Allergy, Asthma & Urticaria Centers of Charleston
state: South Carolina
city: Knoxville
country: United States
facility: New Phase Research and Development
state: Tennessee
city: Austin
country: United States
facility: ISIS Clinical Research, LLC
state: Texas
city: Austin
country: United States
facility: Sirius Clinical Research LLC
state: Texas
city: Dallas
country: United States
facility: AARA Research Center
state: Texas
city: Dallas
country: United States
facility: Pharmaceutical Research & Consulting Inc.
state: Texas
city: El Paso
country: United States
facility: Western Sky Medical Research
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Antonio
country: United States
facility: Quality Research Inc.
state: Texas
city: San Antonio
country: United States
facility: Diagnostics Research Group
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research Associates
state: Texas
city: Waco
country: United States
facility: Allergy Asthma Research Institute
state: Texas
city: Bellevue
country: United States
facility: The Asthma & Allergy Center - Bellevue
state: Washington
Study officials:
References: