A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergic Rhinitis

Last updated: September 20, 2023
Sponsor: Synmosa Biopharma Corp.
Overall Status: Completed

Phase

2

Condition

Allergy

Allergy (Pediatric)

Rhinitis, Allergic, Perennial

Treatment

Dymista™

azelastine/fluticasone 137/50 mcg nasal spray

Clinical Study ID

NCT06051786
AFC-TW-001
  • Ages > 20
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of Azelastine HCl-Fluticasone propionate Nasal Spray 137-50 mcg/spray compared to Dymista™ in patients with perennial allergic rhinitis

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 20 years of age and older.
  2. For female subjects of childbearing potential: agreement to practice birth control forthe duration of the study with either A. A birth control form with a failure rate of < 1%: intrauterine device, hormonal contraceptive and abstinence; or B. A combination ofbirth control forms resulting in a failure rate of < 1%: male condom, female condom ordiaphragm in combination with another adequate form of birth control (intrauterinedevice, hormonal contraceptive, male condom, female condom or diaphragm).
  3. A medical history consistent with AR as judged by the investigator.
  4. Allergy to perennial allergen demonstrated by Multiple Antigen Simultaneous Test (MAST) or ImmunoCAP test (> or = Class 1) within 12 months of the screening visit orduring screening as assessed by the investigator.
  5. If receiving immunotherapy injections, on a stable regimen for at least 30 days priorto Visit 2. Immunotherapy injections are defined as controlled repetitive dosing ofallergen(s) at regular intervals, in order to increase immune tolerance to theoffending allergen(s).
  6. In order to enter the washout period, a reflective TNSS score of at least 6 on Visit
  7. In order to enter the treatment period, a Baseline reflective TNSS score of at least
  8. The Baseline rTNSS is the mean of the rTNSS scores for the last 3 days of thewashout period and the rTNSS score at the randomization visit.
  9. Signed written informed consent.

Exclusion

Exclusion Criteria:

  1. For females: Pregnancy, lactating, or planning to become pregnant during the studyperiod.
  2. Active or quiescent tuberculosis infections of the respiratory tract; Active anduntreated local or systemic fungal, bacterial, viral, or parasitic infections withinthe 12months prior to the screening visit.
  3. Presence of glaucoma, cataracts, ocular herpes simplex, conjunctivitis, or other eyeinfection within the 12 months prior to the screening visit.
  4. Presence of any clinically significant nasal mucosal erosion, nasal septal ulcers, orseptum perforation on focused nasal examination.
  5. Nasal or sinus surgery or nasal trauma within the previous year likely to affectdeposition of intranasal medication in the judgment of the investigator.
  6. Other nasal disease(s) likely to affect deposition of intranasal medication, such aschronic sinusitis, rhinitis medicamentosa, clinically significant polyposis, orclinically significant nasal structural abnormalities (patients with severe nasalseptum deviation, nasal stenosis or cleft lip and cleft palate).
  7. Presence or history of any clinically significant condition that, in the judgment ofthe investigator, would compromise the safety of the subject or the conduct of thestudy.
  8. Use of any investigational drug within 30 days prior to Visit 2.
  9. Hypersensitivity to azelastine hydrochloride, fluticasone propionate, or any inactiveingredients of the investigational product.
  10. Respiratory tract infection requiring antibiotics within 14 days prior to Visit 2.
  11. Has clinically significant pulmonary disease, including asthma (with the exception ofmild intermittent asthma) or chronic obstructive pulmonary disease (COPD).
  12. Known history of alcohol, drug, or substance abuse in the 12 months prior toscreening.
  13. Use of any prohibited medications and treatments (including antihistamines,decongestants, leukotriene antagonists, corticosteroids and other nasal therapies,)within the time period specified in the protocol prior to Visit 2.

Study Design

Total Participants: 136
Treatment Group(s): 2
Primary Treatment: Dymista™
Phase: 2
Study Start date:
August 20, 2020
Estimated Completion Date:
July 20, 2021

Study Description

This study is an open label, randomized, parallel-group study to evaluate the efficacy and safety of azelastine/fluticasone 137/50 mcg nasal spray, to Dymista™ nasal spray in perennial allergic rhinitis (PAR) patients.

An estimated 200 evaluable subjects are planned for this study. Subjects who are at least 20 years of age with PAR and meet the eligibility criteria will be eligible for this study.

There will be a 7-day washout period to establish a baseline, followed by a 28-day treatment period. All subjects who qualify after the washout period will be randomized to receive the test formulation of azelastine/fluticasone or Dymista™ during the treatment period, administered as one spray in each nostril twice daily for 28 days.

Subjects will self-score their symptoms twice daily (AM and PM, approximately 12 hours apart at the same times daily) throughout the washout period and the treatment period. During the treatment period, scoring should be made immediately prior to each dose to reflect the previous 12 hours (reflective scores). The 4 symptoms evaluated are: runny nose, sneezing, nasal itching, and congestion. Each of the symptoms will be scored on a scale of 0 to 3, with 0 indicating absent symptoms and 3 indicating severe symptoms (symptoms that are hard to tolerate; causes interference with activities of daily living and/or sleeping).

The primary endpoint is the difference in the mean change in reflective total nasal symptom scores (rTNSS) from baseline to the end of the treatment period.

Connect with a study center

  • Taichung Veterans General Hospital

    Taichung, 407
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan, 704
    Taiwan

    Site Not Available

  • Cathay General Hospital

    Taipei, 106
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei, 112
    Taiwan

    Site Not Available

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