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

Seasonal Allergic Rhinitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02230696
• Other study ID #: PRG-NY-14-018
• Status: Completed
• Phase: Phase 3
• Start date: August 2014
• Est. completion date: February 2015

Study information

• Verified date: October 2021
• Source: Padagis LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 951
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray
137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate
• Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray
137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate
• Placebo nasal spray
Placebo nasal spray

Locations

Country	Name	City	State
United States	ISIS Clinical Research, LLC	Austin	Texas
United States	Sirius Clinical Research LLC	Austin	Texas
United States	Chesapeake Clinical Research, Inc.	Baltimore	Maryland
United States	The Asthma & Allergy Center - Bellevue	Bellevue	Washington
United States	Clinical Research of the Ozarks, Inc.	Columbia	Missouri
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	Allergy and Asthma Center of NC	High Point	North Carolina
United States	New Phase Research and Development	Knoxville	Tennessee
United States	Family Allergy and Asthma Research Institute	Louisville	Kentucky
United States	Clinical Research Institute LLC	Minneapolis	Minnesota
United States	Clinical Research Institute, Inc.	Minneapolis	Minnesota
United States	Central Texas Health Research	New Braunfels	Texas
United States	National Allergy, Asthma & Urticaria Centers of Charleston	North Charleston	South Carolina
United States	NEMRA Northeast Medical Research Associates, Inc	North Dartmouth	Massachusetts
United States	Allergy, Asthma & Clinical Research Center	Oklahoma City	Oklahoma
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	Island Medical Research, P.C.	Rockville Centre	New York
United States	Clinical Research of the Ozarks, Inc.	Rolla	Missouri
United States	The Clinical Research Center, LLC	Saint Louis	Missouri
United States	Diagnostics Research Group	San Antonio	Texas
United States	Quality Research Inc.	San Antonio	Texas
United States	Sylvana Research Associates	San Antonio	Texas
United States	Princeton Center for Clinical Research	Skillman	New Jersey
United States	Atlanta Allergy & Asthma Clinic, PA	Stockbridge	Georgia
United States	Clinical Research Atlanta (CRA)	Stockbridge	Georgia
United States	Toledo Center for Clinical Research	Sylvania	Ohio
United States	Vital Prospects Clinical Research Institute, P.C.	Tulsa	Oklahoma
United States	Allergy Asthma Research Institute	Waco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Padagis LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean Change From Baseline in the Mean Instantaneous Total Nasal Symptom Score (iTNSS)	The symptoms included in the instantaneous Total Nasal Symptom Score (iTNSS) 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	Change From Baseline iTNSS Scores on Day 1 Post First Randomized Dose	This outcome measured the time to statistical significance of the reduction of signs/symptoms over a 4 hour period on Day 1 only by measuring the reduction in iTNSS scores. When the change from baseline was statistically significant, it was associated with a time to onset of the anti-histamine component of the formulation.; Subjects will record iTNSS scores for 4 hours post first randomized dose. The symptoms included in the instantaneous Total Nasal Symptom Score (iTNSS) 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, up to four hours post the first dose