A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergic Rhinitis
Allergic Rhinitis
About this trial
This is an interventional treatment trial for Allergic Rhinitis focused on measuring Azelastine, Fluticasone
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Taichung Veterans General Hospital
- National Cheng Kung University Hospital
- National Taiwan University Hospital
- Cathay General Hospital
- Taipei Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
azelastine hydrochloride and fluticasone propionate, 137/50 mcg
Dymista™
The test product, azelastine hydrochloride and fluticasone propionate, 137/50 mcg is manufactured by the sponsor, administered as one spray in each nostril twice daily for 28 days.
The active control product, Dymista™, is manufactured by Meda Pharmaceuticals, administered as one spray in each nostril twice daily for 28 days.