Allergic RhinitisPhase 2NCT06051786
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergic Rhinitis
A Phase 2 study testing azelastine/fluticasone 137/50 mcg nasal spray and Dymista™ in people with Allergic Rhinitis, run by Synmosa Biopharma Corp. at 5 sites in Taiwan.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- azelastine/fluticasone 137/50 mcg nasal spray and Dymista™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 5 sitesTaiwan
- Study dates
- 20 Aug 2020to 20 Jul 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
Taichung Veterans General Hospital
Taichung, 407
National Cheng Kung University Hospital
Tainan, 704
National Taiwan University Hospital
Taipei, 100
Cathay General Hospital
Taipei, 106
Taipei Veterans General Hospital
Taipei, 112
About this study
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
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
Read the 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.
- Conditions
- Allergic Rhinitis
- Being tested
- azelastine/fluticasone 137/50 mcg nasal spray, Dymista™
- Keywords
- Azelastine, Fluticasone
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azelastine/fluticasone 137/50 mcg nasal sprayDrug
Also called AFC
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).
Dymista™Drug
Also called AZE/FLU
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).
| Study group | Role | What they receive |
|---|---|---|
| azelastine hydrochloride and fluticasone propionate, 137/50 mcg | Experimental | 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. Receives: Drug: azelastine/fluticasone 137/50 mcg nasal spray |
| Dymista™ | Active comparator | The active control product, Dymista™, is manufactured by Meda Pharmaceuticals, administered as one spray in each nostril twice daily for 28 days. Receives: Drug: Dymista™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in reflective total nasal symptom scores (rTNSS)
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).
Measured: 4 weeks
Secondary outcomes (2)
Nasal examinations
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.
Measured: 4 weeks
Adverse events
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start20 Aug 2020
- Primary completion20 Jul 2021
- Study completion20 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synmosa Biopharma Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Te-Huei Yeh, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051786
- Sponsor's protocol ID
- AFC-TW-001
- Status last verified
- Aug 2023
- First submitted
- 31 Aug 2023
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06051786
- Acronym / sponsor ID
- AFC-TW-001
- Conditions
- Allergic Rhinitis
- Keywords
- Azelastine, Fluticasone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Synmosa Biopharma Corp.Industry (pharma, biotech, devices)
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 20 Jul 2021 (actual)
- Study completion
- 20 Jul 2021 (actual)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| azelastine hydrochloride and fluticasone propionate, 137/50 mcg | Experimental | Drug: azelastine/fluticasone 137/50 mcg nasal sprayThe 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. |
| Dymista™ | Active comparator | Drug: Dymista™The active control product, Dymista™, is manufactured by Meda Pharmaceuticals, administered as one spray in each nostril twice daily for 28 days. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| azelastine/fluticasone 137/50 mcg nasal sprayAlso: AFCAFC 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). | Drug | azelastine hydrochloride and fluticasone propionate, 137/50 mcg |
| Dymista™Also: AZE/FLUDymista™ 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). | Drug | Dymista™ |
Primary outcome
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).
2 secondary outcomes
Nasal examinations
Time frame: 4 weeks
Adverse events
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Te-Huei Yeh, MD principal investigator
National Taiwan University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing azelastine/fluticasone 137/50 mcg nasal spray and Dymista™ in people with Allergic Rhinitis, run by Synmosa Biopharma Corp. at 5 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in reflective total nasal symptom scores (rTNSS) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2023.