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

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.

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: Placebo nasal spray; Drug: Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray

• Study Type: Interventional
• Enrollment (Actual): 951
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Stockbridge, Georgia, United States, 30281
      • Atlanta Allergy & Asthma Clinic, PA
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta (CRA)
  • Kentucky
    • Louisville, Kentucky, United States, 40215
      • Family Allergy and Asthma Research Institute
  • Maryland
    • Baltimore, Maryland, United States, 21236
      • Chesapeake Clinical Research, Inc.
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • NEMRA Northeast Medical Research Associates, Inc
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute, Inc.
    • Minneapolis, Minnesota, United States, 63141
      • Clinical Research Institute LLC
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Clinical Research of The Ozarks, Inc.
    • Rolla, Missouri, United States, 65401
      • Clinical Research of The Ozarks, Inc.
    • Saint Louis, Missouri, United States, 63141
      • The Clinical Research Center, LLC
  • New Jersey
    • Skillman, New Jersey, United States, 08558
      • Princeton Center for Clinical Research
  • New York
    • Rockville Centre, New York, United States, 11570
      • Island Medical Research, P.C.
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Allergy and Asthma Center of NC
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Clinical Research
  • Ohio
    • Sylvania, Ohio, United States, 43560
      • Toledo Center for Clinical Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Allergy, Asthma & Clinical Research Center
    • Tulsa, Oklahoma, United States, 74136
      • Vital Prospects Clinical Research Institute, P.C.
  • South Carolina
    • North Charleston, South Carolina, United States, 29420
      • National Allergy, Asthma & Urticaria Centers of Charleston
  • Tennessee
    • Knoxville, Tennessee, United States, 37919
      • New Phase Research and Development
  • Texas
    • Austin, Texas, United States, 78731
      • ISIS Clinical Research, LLC
    • Austin, Texas, United States, 78759
      • Sirius Clinical Research LLC
    • Dallas, Texas, United States, 75231
      • AARA Research Center
    • Dallas, Texas, United States, 75231
      • Pharmaceutical Research & Consulting Inc.
    • El Paso, Texas, United States, 79904
      • Western Sky Medical Research
    • New Braunfels, Texas, United States, 78130
      • Central Texas Health Research
    • San Antonio, Texas, United States, 78229
      • Diagnostics Research Group
    • San Antonio, Texas, United States, 78209
      • Quality Research Inc.
    • San Antonio, Texas, United States, 78257
      • Sylvana Research Associates
    • Waco, Texas, United States, 76712
      • Allergy Asthma Research Institute
  • Washington
    • Bellevue, Washington, United States, 68123
      • The Asthma & Allergy Center - Bellevue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Product; Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Perrigo	Drug: Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray; 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate; Other Names: Reference Listed Drug Product
Active Comparator: Reference Product; Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray - Meda	Drug: Azelastine Hydrochloride/Fluticasone Propionate Nasal Spray; 137 micro-grams Azelastine Hydrochloride, 50 micro-grams Fluticasone Propionate; Other Names: Reference Listed Drug Product
Placebo Comparator: Placebo Product; Placebo nasal spray	Drug: Placebo nasal spray; Placebo nasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Padagis LLC

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: August 29, 2014
• First Submitted That Met QC Criteria: September 2, 2014
• First Posted (Estimate): September 3, 2014

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Lipoxygenase Inhibitors; Fluticasone; Xhance; Azelastine
• Other Study ID Numbers: PRG-NY-14-018