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AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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:

  1. Male or female patient 12 years of age or older.
  2. Provide written informed consent.
  3. 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.
  1. 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.
  2. Conducting the Lead-in Period according to the protocol.
  3. Willing and able to comply with the study requirements.
  4. At least a 2-year history of AR (seasonal and/or perennial) during the same time of year as the scheduled study time.
  5. 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).
  6. 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.
  7. Patient agrees to avoid prohibited medication and alcohol and use effective methods of contraception during the study.
  8. 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:

  1. Presence of any hypersensitivity to drugs similar to azelastine hydrochloride, fluticasone propionate, or to any of the excipients.
  2. Women who are pregnant or nursing.
  3. Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception.
  4. Clinically significant arrhythmia (or unstable despite medical treatment) or symptomatic cardiac conditions.
  5. A known history of alcohol or drug abuse within the last 2 years.
  6. Diagnosis of human immunodeficiency virus (HIV) infection.
  7. Patients with a diagnosis of Glaucoma, cataract, or central serous chorioretinopathy (CSCR). Lack of suitability for the study:
  8. 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).
  9. Nasal surgery or sinus surgery within the previous year.
  10. Chronic sinusitis - more than 3 episodes per year.
  11. Major malignancies including pheochromocytoma within the last 5 years. Exception will be considered where malignancies have been resolved as judged by Investigator.
  12. 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.
  13. Respiratory Tract Infections including within 14 days prior to Screening Visit.
  14. 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.
  15. Other significant diseases of bronchus and lungs including chronic obstructive pulmonary disease (COPD), emphysema, bronchiectasis, tuberculosis, pneumonia.
  16. 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.
  17. 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.
  18. Current use or expected requirement of ritonavir or strong P4503A4 inhibitors including cobicistat-containing products.
  19. 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.
  20. Use of certain medications or therapies (e.g. for Allergic Rhinitis) within a specified time period Administrative reasons:
  21. Planned travel outside of the aeroallergen area during the study period.
  22. Employees of the Sponsor, research centre or private practice and their family members.
  23. 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

Other trials in China

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.

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 groups in NCT03599791
Study groupRoleWhat they receive
Azelastine Hydrochl. + Fluticasone Prop.ExperimentalDrug: 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 hydrochlorideActive comparatorDrug: 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 propionateActive comparatorDrug: 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.

  1. 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.

  1. First posted26 Jul 2018
  2. Study start29 Jun 2018
  3. Primary completion24 Sep 2019
  4. Study completion24 Sep 2019

Resources

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)
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

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.

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