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
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 20 years of age and older.
- 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).
- A medical history consistent with AR as judged by the investigator.
- 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.
- 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).
- In order to enter the washout period, a reflective TNSS score of at least 6 on Visit
- In order to enter the treatment period, a Baseline reflective TNSS score of at least
- 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.
- Signed written informed consent.
Exclusion
Exclusion Criteria:
- For females: Pregnancy, lactating, or planning to become pregnant during the studyperiod.
- 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.
- Presence of glaucoma, cataracts, ocular herpes simplex, conjunctivitis, or other eyeinfection within the 12 months prior to the screening visit.
- Presence of any clinically significant nasal mucosal erosion, nasal septal ulcers, orseptum perforation on focused nasal examination.
- Nasal or sinus surgery or nasal trauma within the previous year likely to affectdeposition of intranasal medication in the judgment of the investigator.
- 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).
- 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.
- Use of any investigational drug within 30 days prior to Visit 2.
- Hypersensitivity to azelastine hydrochloride, fluticasone propionate, or any inactiveingredients of the investigational product.
- Respiratory tract infection requiring antibiotics within 14 days prior to Visit 2.
- Has clinically significant pulmonary disease, including asthma (with the exception ofmild intermittent asthma) or chronic obstructive pulmonary disease (COPD).
- Known history of alcohol, drug, or substance abuse in the 12 months prior toscreening.
- 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
Connect with a study center
Taichung Veterans General Hospital
Taichung, 407
TaiwanSite Not Available
National Cheng Kung University Hospital
Tainan, 704
TaiwanSite Not Available
Cathay General Hospital
Taipei, 106
TaiwanSite Not Available
National Taiwan University Hospital
Taipei, 100
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei, 112
TaiwanSite Not Available
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