Clinical Trials List
2020-03-01 - 2021-10-13
Phase III
Recruiting5
ICD-10J30.9
Allergic rhinitis, unspecified
An Open-Label, Randomized, Parallel-Group, Multi-Site Study to Evaluate the Efficacy and Safety of Azelastine HCl-Fluticasone propionate Nasal Spray 137-50 mcg/spray in Perennial Allergic Rhinitis patients
-
Trial Applicant
-
Sponsor
Synmosa
-
Trial scale
Taiwan Multiple Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 王拔群 Division of Otolaryngology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 趙勻廷 Division of Otolaryngology
- 葉建甫 Division of Otolaryngology
- Chien-Fu Yeh Division of Otolaryngology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Fluticasone propionate
Dosage Form
nasal spray
Dosage
50
Endpoints
Change in reflective total nasal symptom scores (rTNSS) from baseline to the end of the
treatment period
Secondary Endpoint
Safety assessment including nasal examinations, laboratory testing and adverse events
Inclution Criteria
2. For female subjects of childbearing potential: agreement to practice birth control for
the duration of the study.
3. A medical history consistent with AR as judged by the investigator.
4. Allergy to perennial allergen demonstrated by MAST or ImmunoCAP test ( Class 1)
within 12 months of the screening visit or during screening as assessed by the
investigator.
5. 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).
6. In order to enter the placebo run-in period, a reflective TNSS score of at least 6 on Visit
2.
7. 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 placebo
run-in period and the rTNSS score at the randomization visit.
8. Signed written informed consent.
Exclusion Criteria
period.
2. Active or quiescent tuberculosis infections of the respiratory tract; Active and
untreated local or systemic fungal, bacterial, viral, or parasitic infections at the
screening visit.
3. Presence of glaucoma, cataracts, ocular herpes simplex, conjunctivitis, or other eye
infection at the screening visit.
4. Presence of any clinically significant nasal mucosal erosion, nasal septal ulcers, or
septum perforation on focused nasal examination.
5. Nasal or sinus surgery or nasal trauma within the previous year likely to affect
deposition of intranasal medication in the judgment of the investigator.
6. 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).
7. 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.
8. Use of any investigational drug within 30 days prior to Visit 2.
9. Hypersensitivity to azelastine hydrochloride, fluticasone propionate, or any inactive
ingredients 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 of
mild intermittent asthma) or COPD.
12. Known history of alcohol, drug, or substance abuse in the 12 months prior to screening.
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.
The Estimated Number of Participants
-
Taiwan
250 participants
-
Global
0 participants
