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

• ClinicalTrials.gov Identifier: NCT06051786
• Recruitment Status: Completed
• First Posted: September 25, 2023
• Last Update Posted: September 25, 2023
• Sponsor: Synmosa Biopharma Corp.
• Information provided by (Responsible Party): Synmosa Biopharma Corp.

Study Description

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

Condition or disease	Intervention/treatment	Phase
Allergic Rhinitis	Drug: azelastine/fluticasone 137/50 mcg nasal spray; Drug: Dymista™	Phase 2

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 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 136 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: August 20, 2020
• Actual Primary Completion Date: July 20, 2021
• Actual Study Completion Date: July 20, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: azelastine hydrochloride and fluticasone propionate, 137/50 mcg; 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.	Drug: azelastine/fluticasone 137/50 mcg nasal spray; AFC is a fixed-dose combination product of Azelastine hydrochloride (137mcg), a selective H1-receptor antagonist and, Fluticasone propionate (50mcg), a corticosteroid. AFC is administered intranasally and is used to treat Allergic Rhinitis (AR).; Other Name: AFC
Active Comparator: Dymista™; The active control product, Dymista™, is manufactured by Meda Pharmaceuticals, administered as one spray in each nostril twice daily for 28 days.	Drug: Dymista™; Dymista™ is a fixed-dose combination product of Azelastine hydrochloride (137mcg), a selective H1-receptor antagonist and, Fluticasone propionate (50mcg), a corticosteroid. Dymista™ is administered intranasally and is used to treat Allergic Rhinitis (AR).; Other Name: AZE/FLU

Outcome Measures

Primary Outcome Measures :

1. Change in reflective total nasal symptom scores (rTNSS) [ Time Frame: 4 weeks ]
   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).

Secondary Outcome Measures :

1. Nasal examinations [ Time Frame: 4 weeks ]
   The Nasal Examination includes an evaluation for nasal irritation, epistaxis, and additional nasal symptoms including mucosal edema, nasal discharge, mucosal erythema, mucosal bleeding, and crusting of mucosa.
2. Adverse events [ Time Frame: 4 weeks ]
   An adverse event is any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. 20 years of age and older.
2. 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).
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 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 washout 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 washout period and the rTNSS score at the randomization visit.
8. Signed written informed consent.

Exclusion Criteria:

1. For females: Pregnancy, lactating, or planning to become pregnant during the study period.
2. 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.
3. Presence of glaucoma, cataracts, ocular herpes simplex, conjunctivitis, or other eye infection within the 12 months prior to 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 chronic obstructive pulmonary disease (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.

Contacts and Locations

Locations

Taiwan

Taichung Veterans General Hospital

Taichung, Taiwan, 407

National Cheng Kung University Hospital

Tainan, Taiwan, 704

National Taiwan University Hospital

Taipei, Taiwan, 100

Cathay General Hospital

Taipei, Taiwan, 106

Taipei Veterans General Hospital

Taipei, Taiwan, 112

Sponsors and Collaborators

Synmosa Biopharma Corp.

Investigators

• Principal Investigator: Te-Huei Yeh, MD; National Taiwan University Hospital

More Information

• Responsible Party: Synmosa Biopharma Corp.
• ClinicalTrials.gov Identifier: NCT06051786
• Other Study ID Numbers: AFC-TW-001
• First Posted: September 25, 2023
• Last Update Posted: September 25, 2023
• Last Verified: August 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Synmosa Biopharma Corp.:

Azelastine; Fluticasone

Additional relevant MeSH terms:

Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Fluticasone; Azelastine; Anti-Inflammatory Agents; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Dermatologic Agents; Anti-Allergic Agents; Lipoxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Histamine H1 Antagonists, Non-Sedating; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents