Status:
COMPLETED
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergic Rhinitis
Lead Sponsor:
Synmosa Biopharma Corp.
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief 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
Detailed 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 rhinit...
Eligibility Criteria
Inclusion
- 20 years of age and older.
- For female subjects of childbearing potential: agreement to practice birth control for the 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 of birth control forms resulting in a failure rate of \< 1%: male condom, female condom or diaphragm in combination with another adequate form of birth control (intrauterine device, 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 or during screening as assessed by the investigator.
- If receiving immunotherapy injections, on a stable regimen for at least 30 days prior to Visit 2. Immunotherapy injections are defined as controlled repetitive dosing of allergen(s) at regular intervals, in order to increase immune tolerance to the offending allergen(s).
- In order to enter the washout period, a reflective TNSS score of at least 6 on Visit 2.
- In order to enter the treatment period, a Baseline reflective TNSS score of at least 6. The Baseline rTNSS is the mean of the rTNSS scores for the last 3 days of the washout period and the rTNSS score at the randomization visit.
- Signed written informed consent.
Exclusion
- For females: Pregnancy, lactating, or planning to become pregnant during the study period.
- Active or quiescent tuberculosis infections of the respiratory tract; Active and untreated local or systemic fungal, bacterial, viral, or parasitic infections within the 12months prior to the screening visit.
- Presence of glaucoma, cataracts, ocular herpes simplex, conjunctivitis, or other eye infection within the 12 months prior to the screening visit.
- Presence of any clinically significant nasal mucosal erosion, nasal septal ulcers, or septum perforation on focused nasal examination.
- Nasal or sinus surgery or nasal trauma within the previous year likely to affect deposition of intranasal medication in the judgment of the investigator.
- Other nasal disease(s) likely to affect deposition of intranasal medication, such as chronic sinusitis, rhinitis medicamentosa, clinically significant polyposis, or clinically significant nasal structural abnormalities (patients with severe nasal septum deviation, nasal stenosis or cleft lip and cleft palate).
- Presence or history of any clinically significant condition that, in the judgment of the investigator, would compromise the safety of the subject or the conduct of the study.
- Use of any investigational drug within 30 days prior to Visit 2.
- Hypersensitivity to azelastine hydrochloride, fluticasone propionate, or any inactive ingredients 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 of mild intermittent asthma) or chronic obstructive pulmonary disease (COPD).
- Known history of alcohol, drug, or substance abuse in the 12 months prior to screening.
- 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.
Key Trial Info
Start Date :
August 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 20 2021
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT06051786
Start Date
August 20 2020
End Date
July 20 2021
Last Update
September 25 2023
Active Locations (5)
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1
Taichung Veterans General Hospital
Taichung, Taiwan, 407
2
National Cheng Kung University Hospital
Tainan, Taiwan, 704
3
National Taiwan University Hospital
Taipei, Taiwan, 100
4
Cathay General Hospital
Taipei, Taiwan, 106