DYmista NAsal Spray in CHInese Patients

• Status: Completed
• Trial end date: 2019-09-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MEDA Pharma GmbH & Co. KG
• Treatments: Azelastine; Fluticasone; Xhance

Criteria

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.

4. 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.

5. Conducting the Lead-in Period according to the protocol.

6. Willing and able to comply with the study requirements.

7. At least a 2-year history of AR (seasonal and/or perennial) during the same time of year as the scheduled study time.

8. 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).

9. 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.

10. Patient agrees to avoid prohibited medication and alcohol and use effective methods of contraception during the study.

11. 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.