Allergic RhinitisPhase 3DYNAS-CHINCT03599791
DYmista NAsal Spray in CHInese Patients
A Phase 3 study testing Azelastine Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUAT, Azelastine Hydrochloride 0.137 MG/ACTUAT and Fluticasone Propionate 0.05 MG/ACTUAT in people with Allergic Rhinitis, run by MEDA Pharma GmbH & Co. KG at 33 sites in China.
Trial summary
This study is a phase III clinical study to assess the efficacy and safety of Dymista® Nasal Spray in comparison to Azep® nasal spray and Flixonase® nasal spray in Chinese patients aged ≥ 12 years with moderate-to-severe allergic rhinitis/rhinoconjunctivitis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Azelastine Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUAT, Azelastine Hydrochloride 0.137 MG/ACTUAT and Fluticasone Propionate 0.05 MG/ACTUAT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 33 sitesChina
- Study dates
- 29 Jun 2018to 24 Sep 2019
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
General Inclusion Criteria:
To be eligible for enrolment into this study, a patient must comply with all of the following criteria:
- Male or female patient 12 years of age or older.
- Provide written informed consent.
- Patients must have moderate-to-severe rhinitis or rhinoconjunctivitis, defined as rhinitis/rhinoconjunctivitis with one or more of the following being present:
- Sleep disturbance.
- Impairment of daily activities, leisure and/or sport.
- Impairment of learning or work.
- Troublesome symptoms.
- Patients must have moderate-to-severe rhinitis or rhinoconjunctivitis and monotherapy with either intranasal antihistamine or glucocorticoid is not considered sufficient at the discretion of the Investigator and/or designee.
- Conducting the Lead-in Period according to the protocol.
- Willing and able to comply with the study requirements.
- At least a 2-year history of AR (seasonal and/or perennial) during the same time of year as the scheduled study time.
- The presence of Immunoglobulin E (IgE)-mediated hypersensitivity to one or more aeroallergens present in current patient environment, confirmed by a positive response to an established standard diagnostic test at the site within the last year (before randomization).
- General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the Investigator or the sponsor's medical officer. When in doubt, the Investigator should confer with the sponsor's medical monitor or designee to determine eligibility for the study.
- Patient agrees to avoid prohibited medication and alcohol and use effective methods of contraception during the study.
- Negative pregnancy test in women with childbearing potential.
General Exclusion Criteria:
A patient is ineligible and must not enter the study if any of the following criteria is met:
Safety concerns:
- Presence of any hypersensitivity to drugs similar to azelastine hydrochloride, fluticasone propionate, or to any of the excipients.
- Women who are pregnant or nursing.
- Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception.
- Clinically significant arrhythmia (or unstable despite medical treatment) or symptomatic cardiac conditions.
- A known history of alcohol or drug abuse within the last 2 years.
- Diagnosis of human immunodeficiency virus (HIV) infection.
- Patients with a diagnosis of Glaucoma, cataract, or central serous chorioretinopathy (CSCR). Lack of suitability for the study:
- Nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities (e.g. nasal septum deviation).
- Nasal surgery or sinus surgery within the previous year.
- Chronic sinusitis - more than 3 episodes per year.
- Major malignancies including pheochromocytoma within the last 5 years. Exception will be considered where malignancies have been resolved as judged by Investigator.
- The use of any investigational drug within 30 days prior to Screening Visit. No other investigational products are permitted for use during the conduct of this study.
- Respiratory Tract Infections including within 14 days prior to Screening Visit.
- Asthma (with the exception of mild intermittent asthma). Patients with mild intermittent asthma who only require short-acting inhaled bronchodilators and who do not have nocturnal awakening as a result of asthma are eligible for enrolment.
- Other significant diseases of bronchus and lungs including chronic obstructive pulmonary disease (COPD), emphysema, bronchiectasis, tuberculosis, pneumonia.
- Any surgical or medical condition or physical or laboratory findings, which in the opinion of the Investigator or sponsor's medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug; that might significantly affect the patient's ability to complete this trial; or their safety in this trial.
- Clinically relevant abnormal physical findings during the Lead-in Period which, in the opinion of the Investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures.
- Current use or expected requirement of ritonavir or strong P4503A4 inhibitors including cobicistat-containing products.
- Specific immunotherapy within 6 months prior to Screening Visit. If the patient received immunotherapy a 6-month washout period is required following the last dose of immunotherapy.
- Use of certain medications or therapies (e.g. for Allergic Rhinitis) within a specified time period Administrative reasons:
- Planned travel outside of the aeroallergen area during the study period.
- Employees of the Sponsor, research centre or private practice and their family members.
- Start-of-treatment Visit (Day 1): have not fully completed Diary.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
China33 sites
Investigational Site 2
Beijing, Beijing Municipality
Investigational Site 3
Beijing, Beijing Municipality
Investigational Site 4
Beijing, Beijing Municipality
Investigational Site 5
Beijing, Beijing Municipality
Investigational Site 1
Beijing, Dongcheng District
Investigational Site
Changchun, Jilin
Investigational Site
Changsha, Hunan
Investigational Site
Changzhi, Shanxi
Investigational Site
Chengdu, Sichuan
Investigational Site
Chongqing, Chonqing
Investigational Site
Dalian, Liaoning
Investigational Site 1
Guangzhou, Guangdong
Investigational Site 2
Guangzhou, Guangdong
Investigational Site
Jining, Jining
Investigational Site
Nanchang, Jiangxi
Investigational Site
Nanjing, Nanjing
Investigational Site 1
Qingdao, Shandong
Investigational Site 2
Qingdao, Shandong
Investigational Site
Shanghai, Shanghai Municipality
Investigational Site
Taiyuan, Shanxi
Investigational Site 1
Tianjin, Tianjin Municipality
Investigational Site 2
Tianjin, Tianjin Municipality
Investigational Site 3
Tianjin, Tianjin Municipality
Investigational Site 4
Tianjin, Tianjin Municipality
Investigational Site
Tonghua, Jilin
Investigational Site
Ürümqi, Xianjiang Uygur
Investigational Site 1
Wuhan, Hubei
Investigational Site 2
Wuhan, Hubei
Investigational Site 1
Xi’an, Shanxi
Investigational Site 2
Xi’an, Shanxi
Investigational Site
Yanbian, Jilin
Investigational Site
Yantai, Shangdong
Investigational Site
Zibo, Shangdong
About this study
Official title: Multicentre, Randomized, Double-blind, Parallel Group Phase III Study to Assess Efficacy and Safety of Dymista® Compared to Azep® and Flixonase® Nasal Sprays in the Treatment of Chinese Patients With Allergic Rhinitis/Rhinoconjunctivitis
This study is a phase III clinical study to assess the efficacy and safety of Dymista® Nasal Spray in comparison to Azep® nasal spray and Flixonase® nasal spray in Chinese patients aged ≥ 12 years with moderate-to-severe allergic rhinitis/rhinoconjunctivitis.
Read the detailed description
This is a multicentre, randomized, active controlled prospective clinical trial in adult and adolescent patients with AR (seasonal and/or perennial), who have moderate-to-severe symptoms (rhinitis/ rhinoconjunctivitis), based on the Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 Guidelines. The study consists of a 3 to 7-day Lead-in Period during which patients must meet a minimum symptom severity score to be eligible for the Treatment Period. All patients will start the Lead-in Period straight after Screening Visit as soon as in/exclusion criteria are fulfilled. The Lead-in Period will be followed by a 14-day double-blind Treatment Period. At some time point during the study, patients will receive Placebo and Dymista® nasal spray or Azep® nasal spray or Flixonase® nasal spray, 1 spray per nostril twice daily according to randomization. On the first day of the Lead-in Period patients must meet study inclusion/exclusion criteria and have a sufficient AR symptom score to qualify for entry. Qualified patients will be requested to keep a Diary of nasal and ocular symptoms throughout the study period. Additionally, patients will be requested to complete the Adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and EuroQoL 5D questionnaire (EQ-5D) on Day 1, Day 8 and Day 15. Both Questionnaires will be completed by adult patients only.
- Conditions
- Allergic Rhinitis
- Being tested
- Azelastine Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUAT, Azelastine Hydrochloride 0.137 MG/ACTUAT, Fluticasone Propionate 0.05 MG/ACTUAT
- Keywords
- Allergic Rhinitis, hayfever, rhinoconjunctivitis, azelastine, fluticasone, nasal spray, seasonal, perennial, TNSS, TOSS
- Medical subject headings
- Rhinitis, Allergic, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azelastine Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUATDrug
Also called Dymista
Dymista Nasal spray suspension
Azelastine Hydrochloride 0.137 MG/ACTUATDrug
Also called AZEP
AZEP Nasal spray solution
Fluticasone Propionate 0.05 MG/ACTUATDrug
Also called Flixonase
Fluticasone propionate nasal spray suspension
| Study group | Role | What they receive |
|---|---|---|
| Azelastine Hydrochl. + Fluticasone Prop. | Experimental | Drug: Azelastine Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUAT Nasal Spray, consists of a fixed-dose combination of azelastine hydrochloride and fluticasone propionate; 1 spray per nostril twice daily for 14 days, with 3 to 7 days of lead-in period. At a certain point during the study, patients will receive Placebo. Receives: Drug: Azelastine Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUAT |
| Azelastine hydrochloride | Active comparator | Drug: Azelastine Hydrochloride 0.137 MG/ACTUAT Nasal Spray, 1 spray per nostril twice daily for 14 days, with 3 to 7 days of lead-in period. At a certain point during the study, patients will receive Placebo. Receives: Drug: Azelastine Hydrochloride 0.137 MG/ACTUAT |
| Fluticasone propionate | Active comparator | Drug: Fluticasone Propionate 0.05 MG/ACTUAT Nasal Spray, 1 spray per nostril twice daily for 14 days, with 3 to 7 days of lead-in period. At a certain point during the study, patients will receive Placebo. Receives: Drug: Fluticasone Propionate 0.05 MG/ACTUAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined 12-hour rTNSS (AM + PM)
Total nasal symptom score (TNSSS) is a sum of 4 individual nasal symptom scores: nasal itching, runny nose, congestion and sneezing. Each nasal symptom will be assessed according to a 4-ponit scale (0 = no, 1 = mild, 2 = moderate, 3 = severe symptom); thus, each TNSS will be in the range from 0 (no symptoms at all) to 12 (all 4 symptoms are severe) and the combined 12-hour reflective TNSS (morning + evening) will be in the range of 0 to 24 accordingly
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start29 Jun 2018
- Primary completion24 Sep 2019
- Study completion24 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, randomized, double-blind, active controlled, parallel group study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 900 participants (actual)
Sponsor and investigators
- Lead sponsor
- MEDA Pharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- DucTung Nguyen, Dr., Study director, Meda Pharma GmbH & Co. KG (A Mylan Company)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599791
- Sponsor's protocol ID
- X-03065-3303
- Acronym
- DYNAS-CHI
- Status last verified
- Feb 2020
- First submitted
- 17 Jul 2018
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou B, Cheng L, Pan J, Wang H, Jin Y, Zhao C, Lin P, Tan G, Fang H, Zhang H, Zhou H, Dong Y, Kuhl HC, Ramalingam RK, Nguyen DT. A Clinical Study to Assess the Efficacy and Safety of MP-AzeFlu Nasal Spray in Comparison to Commercially Available Azelastine Hydrochloride and Fluticasone Propionate Nasal Sprays in Chinese Volunteers with Allergic Rhinitis. Pulm Ther. 2023 Sep;9(3):411-427. doi: 10.1007/s41030-023-00238-8. Epub 2023 Aug 14.
PubMed 37580498
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Randomized, Double-blind, Parallel Group Phase III Study to Assess Efficacy and Safety of Dymista® Compared to Azep® and Flixonase® Nasal Sprays in the Treatment of Chinese Patients With Allergic Rhinitis/Rhinoconjunctivitis
- ClinicalTrials.gov ID
- NCT03599791
- Acronym / sponsor ID
- DYNAS-CHI / X-03065-3303
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic Rhinitis, hayfever, rhinoconjunctivitis, azelastine, fluticasone, nasal spray, seasonal, perennial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- MEDA Pharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- 24 Sep 2019 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 26 Jul 2018 (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.
This study is a phase III clinical study to assess the efficacy and safety of Dymista® Nasal Spray in comparison to Azep® nasal spray and Flixonase® nasal spray in Chinese patients aged ≥ 12 years with moderate-to-severe allergic rhinitis/rhinoconjunctivitis.
Detailed description
This is a multicentre, randomized, active controlled prospective clinical trial in adult and adolescent patients with AR (seasonal and/or perennial), who have moderate-to-severe symptoms (rhinitis/ rhinoconjunctivitis), based on the Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 Guidelines. The study consists of a 3 to 7-day Lead-in Period during which patients must meet a minimum symptom severity score to be eligible for the Treatment Period. All patients will start the Lead-in Period straight after Screening Visit as soon as in/exclusion criteria are fulfilled. The Lead-in Period will be followed by a 14-day double-blind Treatment Period. At some time point during the study, patients will receive Placebo and Dymista® nasal spray or Azep® nasal spray or Flixonase® nasal spray, 1 spray per nostril twice daily according to randomization. On the first day of the Lead-in Period patients must meet study inclusion/exclusion criteria and have a sufficient AR symptom score to qualify for entry. Qualified patients will be requested to keep a Diary of nasal and ocular symptoms throughout the study period. Additionally, patients will be requested to complete the Adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and EuroQoL 5D questionnaire (EQ-5D) on Day 1, Day 8 and Day 15. Both Questionnaires will be completed by adult patients only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Multicentre, randomized, double-blind, active controlled, parallel group study
| Arm | Type | Receives |
|---|---|---|
| Azelastine Hydrochl. + Fluticasone Prop. | Experimental | Drug: Azelastine Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUATDrug: Azelastine Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUAT Nasal Spray, consists of a fixed-dose combination of azelastine hydrochloride and fluticasone propionate; 1 spray per nostril twice daily for 14 days, with 3 to 7 days of lead-in period. At a certain point during the study, patients will receive Placebo. |
| Azelastine hydrochloride | Active comparator | Drug: Azelastine Hydrochloride 0.137 MG/ACTUATDrug: Azelastine Hydrochloride 0.137 MG/ACTUAT Nasal Spray, 1 spray per nostril twice daily for 14 days, with 3 to 7 days of lead-in period. At a certain point during the study, patients will receive Placebo. |
| Fluticasone propionate | Active comparator | Drug: Fluticasone Propionate 0.05 MG/ACTUATDrug: Fluticasone Propionate 0.05 MG/ACTUAT Nasal Spray, 1 spray per nostril twice daily for 14 days, with 3 to 7 days of lead-in period. At a certain point during the study, patients will receive Placebo. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUATAlso: DymistaDymista Nasal spray suspension | Drug | Azelastine Hydrochl. + Fluticasone Prop. |
| Azelastine Hydrochloride 0.137 MG/ACTUATAlso: AZEPAZEP Nasal spray solution | Drug | Azelastine hydrochloride |
| Fluticasone Propionate 0.05 MG/ACTUATAlso: FlixonaseFluticasone propionate nasal spray suspension | Drug | Fluticasone propionate |
Primary outcome
Combined 12-hour rTNSS (AM + PM)
Time frame: 14 days
Total nasal symptom score (TNSSS) is a sum of 4 individual nasal symptom scores: nasal itching, runny nose, congestion and sneezing. Each nasal symptom will be assessed according to a 4-ponit scale (0 = no, 1 = mild, 2 = moderate, 3 = severe symptom); thus, each TNSS will be in the range from 0 (no symptoms at all) to 12 (all 4 symptoms are severe) and the combined 12-hour reflective TNSS (morning + evening) will be in the range of 0 to 24 accordingly
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 22 Feb 2022.
- Derived from this study: PubMed 37580498Zhou B, Cheng L, Pan J, Wang H, Jin Y, Zhao C, Lin P, Tan G, Fang H, Zhang H, Zhou H, Dong Y, Kuhl HC, Ramalingam RK, Nguyen DT. A Clinical Study to Assess the Efficacy and Safety of MP-AzeFlu Nasal Spray in Comparison to Commercially Available Azelastine Hydrochloride and Fluticasone Propionate Nasal Sprays in Chinese Volunteers with Allergic Rhinitis. Pulm Ther. 2023 Sep;9(3):411-427. doi: 10.1007/s41030-023-00238-8. Epub 2023 Aug 14.
- 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.
DucTung Nguyen, Dr. study director
Meda Pharma GmbH & Co. KG (A Mylan Company)
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azelastine Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUAT, Azelastine Hydrochloride 0.137 MG/ACTUAT and Fluticasone Propionate 0.05 MG/ACTUAT in people with Allergic Rhinitis, run by MEDA Pharma GmbH & Co. KG at 33 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Combined 12-hour rTNSS (AM + PM) (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03599791, which also lists 1 linked publication.
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 22 Feb 2022.