Comparative Safety and Efficacy of Two Steroid Treatments in the Relief of the Symptoms of Seasonal Allergic Rhinitis
1 other identifier
interventional
951
1 country
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2014
Shorter than P25 for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 29, 2014
CompletedFirst Posted
Study publicly available on registry
September 3, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
March 15, 2021
CompletedOctober 22, 2021
October 1, 2021
6 months
August 29, 2014
January 8, 2021
October 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline for Mean Reflective Total Nasal Symptom Score (rTNSS)
The symptoms included in the reflective Total Nasal Symptom Score (rTNSS) scale are nasal congestion/stuffy nose, nasal discharge/runny nose, sneezing, and itchy nose. Symptoms were scored on a four point scale, 0-3, for each assessment were calculated by totaling these four symptom scores for a maximum score of 12.
Day 1 through Day 14
Secondary Outcomes (2)
Mean Change From Baseline in the Mean Instantaneous Total Nasal Symptom Score (iTNSS)
Day 1 through Day 14
Change From Baseline iTNSS Scores on Day 1 Post First Randomized Dose
Day 1, up to four hours post the first dose
Study Arms (3)
Test Product
EXPERIMENTALAzelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Perrigo
Reference Product
ACTIVE COMPARATORAzelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Meda
Placebo Product
PLACEBO COMPARATORPlacebo nasal spray
Interventions
137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate
Eligibility Criteria
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.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Padagis LLClead
Study Sites (30)
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, Inc.
Minneapolis, Minnesota, 55402, United States
Clinical Research Institute LLC
Minneapolis, Minnesota, 63141, 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
St 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
North 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
Quality Research Inc.
San Antonio, Texas, 78209, United States
Diagnostics Research Group
San Antonio, Texas, 78229, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jonathan Schwartz
- Organization
- Perrigo
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2014
First Posted
September 3, 2014
Study Start
August 1, 2014
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
October 22, 2021
Results First Posted
March 15, 2021
Record last verified: 2021-10