DYmista NAsal Spray in CHInese Patients

Last updated: February 4, 2022
Sponsor: MEDA Pharma GmbH & Co. KG
Overall Status: Completed

Phase

3

Condition

Common Cold

Acute Rhinitis

Allergies & Asthma

Treatment

N/A

Clinical Study ID

NCT03599791
X-03065-3303
  • Ages > 12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

General Inclusion Criteria: To be eligible for enrolment into this study, a patient must comply with all of thefollowing 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 asrhinitis/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 monotherapywith either intranasal antihistamine or glucocorticoid is not considered sufficient atthe 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 ofyear as the scheduled study time.
  5. The presence of Immunoglobulin E (IgE)-mediated hypersensitivity to one or moreaeroallergens present in current patient environment, confirmed by a positive responseto an established standard diagnostic test at the site within the last year (beforerandomization).
  6. General good health and free of any disease or concomitant treatment that couldinterfere with the interpretation of the study results as determined by theInvestigator or the sponsor's medical officer. When in doubt, the Investigator shouldconfer with the sponsor's medical monitor or designee to determine eligibility for thestudy.
  7. Patient agrees to avoid prohibited medication and alcohol and use effective methods ofcontraception during the study.
  8. Negative pregnancy test in women with childbearing potential.

Exclusion

General Exclusion Criteria: A patient is ineligible and must not enter the study if any of the following criteria ismet: 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 medicallyacceptable method of contraception.
  4. Clinically significant arrhythmia (or unstable despite medical treatment) orsymptomatic 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 assinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasalstructural 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 willbe 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 otherinvestigational 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 mildintermittent asthma who only require short-acting inhaled bronchodilators and who donot have nocturnal awakening as a result of asthma are eligible for enrolment.
  15. Other significant diseases of bronchus and lungs including chronic obstructivepulmonary disease (COPD), emphysema, bronchiectasis, tuberculosis, pneumonia.
  16. Any surgical or medical condition or physical or laboratory findings, which in theopinion of the Investigator or sponsor's medical monitor, might significantly alterthe absorption, distribution, metabolism, or excretion of study drug; that mightsignificantly affect the patient's ability to complete this trial; or their safety inthis trial.
  17. Clinically relevant abnormal physical findings during the Lead-in Period which, in theopinion of the Investigator, would interfere with the objectives of the study or thatmay preclude compliance with the study procedures.
  18. Current use or expected requirement of ritonavir or strong P4503A4 inhibitorsincluding cobicistat-containing products.
  19. Specific immunotherapy within 6 months prior to Screening Visit. If the patientreceived immunotherapy a 6-month washout period is required following the last dose ofimmunotherapy.
  20. Use of certain medications or therapies (e.g. for Allergic Rhinitis) within aspecified 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 familymembers.
  23. Start-of-treatment Visit (Day 1): have not fully completed Diary.

Study Design

Total Participants: 900
Study Start date:
June 29, 2018
Estimated Completion Date:
September 24, 2019

Study 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.

Connect with a study center

  • Investigational Site 2

    Beijing, Beijing
    China

    Site Not Available

  • Investigational Site 3

    Beijing, Beijing
    China

    Site Not Available

  • Investigational Site 4

    Beijing, Beijing
    China

    Site Not Available

  • Investigational Site 5

    Beijing, Beijing
    China

    Site Not Available

  • Investigational Site

    Chongqing, Chonqing
    China

    Site Not Available

  • Investigational Site 1

    Beijing, Dongcheng District
    China

    Site Not Available

  • Investigational Site 1

    Guangzhou, Guangdong
    China

    Site Not Available

  • Investigational Site 2

    Guangzhou, Guangdong
    China

    Site Not Available

  • Investigational Site 1

    Wuhan, Hubei
    China

    Site Not Available

  • Investigational Site 2

    Wuhan, Hubei
    China

    Site Not Available

  • Investigational Site

    Changsha, Hunan
    China

    Site Not Available

  • Investigational Site

    Nanchang, Jiangxi
    China

    Site Not Available

  • Investigational Site

    Chang chun, Jilin
    China

    Site Not Available

  • Investigational Site

    Tonghua, Jilin
    China

    Site Not Available

  • Investigational Site

    Yanbian, Jilin
    China

    Site Not Available

  • Investigational Site

    Jining, Jining
    China

    Site Not Available

  • Investigational Site

    Dalian, Liaoning
    China

    Site Not Available

  • Investigational Site

    Nanjing, Nanjing
    China

    Site Not Available

  • Investigational Site 1

    Qingdao, Shandong
    China

    Site Not Available

  • Investigational Site 2

    Qingdao, Shandong
    China

    Site Not Available

  • Investigational Site

    Yantai, Shangdong
    China

    Site Not Available

  • Investigational Site

    Zibo, Shangdong
    China

    Site Not Available

  • Investigational Site

    Shanghai, Shanghai
    China

    Site Not Available

  • Investigational Site

    Changzhi, Shanxi
    China

    Site Not Available

  • Investigational Site

    Taiyuan, Shanxi
    China

    Site Not Available

  • Investigational Site 1

    Xi'an, Shanxi
    China

    Site Not Available

  • Investigational Site 2

    Xi'an, Shanxi
    China

    Site Not Available

  • Investigational Site

    Chengdu, Sichuan
    China

    Site Not Available

  • Investigational Site 1

    Tianjin, Tianjin
    China

    Site Not Available

  • Investigational Site 2

    Tianjin, Tianjin
    China

    Site Not Available

  • Investigational Site 3

    Tianjin, Tianjin
    China

    Site Not Available

  • Investigational Site 4

    Tianjin, Tianjin
    China

    Site Not Available

  • Investigational Site

    Ürümqi, Xianjiang Uygur
    China

    Site Not Available

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