CompletedPhase 3

DYmista NAsal Spray in CHInese Patients

China900 participantsStarted 2018-06-29

Plain-language 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.

Who can participate

Age range12 Years

SexALL

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Inclusion 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:
✓. 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).

Exclusion criteria

✕. 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).
✕. 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).

What they're measuring

Combined 12-hour rTNSS (AM + PM)

Timeframe: 14 days

Trial details

NCT IDNCT03599791

SponsorMEDA Pharma GmbH & Co. KG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-09-24

View on ClinicalTrials.gov More Allergic Rhinitis trials