Multicenter, Phase 4, Single-Arm Clinical Trial to Evaluate Efficacy and Safety of Dymista (Azelastine Hydrochloride and Fluticasone Propionate) Nasal Spray in the Treatment of Allergic Rhinitis in Chinese Adolescents With or Without Ocular Symptoms.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Viatris Inc.
- 入组人数
- 100
- 试验地点
- 29
- 主要终点
- Change from baseline in AM+PM combined reflective Total Nasal Symptom Score (rTNSS).
研究概览
简要总结
The purpose of this study is to determine if the investigational drug product ("study drug"), Dymista (azelastine hydrochloride and fluticasone propionate) nasal spray is safe and effective in the treatment of allergic rhinitis in Chinese adolescents with or without ocular symptoms.
It is expected that approximately, 100 participants will be enrolled in this study. The study will be performed in approximately 15 clinical study centers in China.
Study participants will be asked to complete up to 3 study visits at the study site and a follow-up by telephone.
Treatment Assignment:
All participants will receive a bottle of Dymista nasal spray and should administer it at a dose of twice daily (one spray per nostril), once in the morning and once in the afternoon, the doses will be approximately 12 hours apart. The liquid medicine is sprayed out in a mist after actuator is pressed. You will administer the trial intervention for 14 (+5) days.
Regular study schedule:
- Screening visit (Visit 1, Day -7 to 1)
- Baseline visit (Visit 2, Day 1)
- Visits 3 (End of Trial (EOS), Day 15 (+5))
- Follow-up (Telephone Call, within 14 (+5) days after the last administration of Dymista) The participation may last approximately 29 days to 60 days (depending on extended periods of screening, treatment, and follow-up).
详细描述
Trial Design and Rationale for Trial Design:
This is a multicenter, phase 4, single arm clinical trial to evaluate the efficacy and safety of Dymista nasal spray (137 μg of azelastine hydrochloride and 50 μg of fluticasone propionate) in the treatment of AR in Chinese adolescents with or without ocular symptoms. Because Dymista has already been approved, this trial design is selected to gather additional data on efficacy and safety of Dymista in Chinese adolescents in a close to real-world setting but under clinical oversight.
Number of Participants: Approximately 100 participants will be enrolled into the study.
Number of Arms: Single arm
Duration: Total duration of trial participation for each participant will vary from 29 to 60 days (depending on extended periods of screening, treatment, and follow-up).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female Chinese participants aged 12 to 17 years (inclusive) at screening.
- •informed consent/assent from participants and from parent(s) or legal guardian(s) in compliance with local requirements.
- •Participants must have moderate-to-severe seasonal and/or perennial AR with or without ocular symptoms, defined as rhinitis 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
- •Moderate to severe seasonal and/or perennial AR with or without ocular symptoms in whom intranasal antihistamines or glucocorticoid monotherapy is not considered sufficient at the discretion of the Investigator and/or designee.
- •Presence of Immunoglobulin E (IgE)-mediated hypersensitivity to one or more aeroallergens present in the current participant environment, confirmed by a positive response to an established standard diagnostic test at the site within the last year (before treatment start). Accepted diagnostic tests include:
- •Skin prick tests
- •Specific IgE tests Diagnosis of hypersensitivity will follow the current clinical practice at study sites.
- •Acute allergic rhinitis symptoms at the day of inclusion evidenced by a 12-hour reflective TNSS ≥8 out of
- •General good health and free of any disease or concomitant treatment that may increase the risk associated with study participation or investigational product administration or 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.
- •Negative pregnancy test in females with childbearing potential.
- •Ability to understand and follow the instructions for using Dymista nasal spray according to the participant information leaflet.
- •Willingness to complete and return the Patient Diary and comply with the study requirements.
排除标准
- •Safety concerns:
- •Known allergic reaction from and/or intolerance to Dymista, azelastine hydrochloride, fluticasone propionate nasal sprays or any of the ingredients
- •Pregnancy/planned pregnancy or breastfeeding during this study
- •Lack of suitability for the study:
- •Participants or parent(s)/legal guardian(s) are not able to fulfil study requirements according to Investigator's opinion.
- •Clinically significant nasal or sinus disease that may affect intranasal drug deposition, including but not limited to nasal mucosal erosion/ulceration or septum perforation (Grade 1b - 4), significant polyposis, marked septum deviation, active or recurrent sinusitis (>3 episodes/year), or nasal/sinus surgery within the past 12 months.
- •The use of any investigational drug within 30 days or within 5 half-lives of the investigational drug (whichever is longer) prior to inclusion. No other investigational products are permitted for use during the conduct of this study.
- •Respiratory tract infections within 7 days prior to inclusion.
- •Asthma (with the exception of mild intermittent asthma). Participants 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.
- •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 participant received immunotherapy a 6-month washout period is required following the last dose of immunotherapy.
- •Use of the following medications or therapies within the time period specified below prior to Screening Visit:
- •Medication/Therapy Time Prior to Screening Visit
- •Antihistamines: including oral, ocular, intranasal, prescribed and over the counter, biological active supplements, cold preparation, sleep aids containing such components (5 days)
- •Oral and intranasal anticholinergic agents including ipratropium nasal spray (5 days)
- •Inhaled, oral corticosteroids (30 days)
- •Intranasal corticosteroids (14 days)
- •Systemic steroids, includes oral, injected, intravenous [IV], (30 days)
- •Ocular corticosteroids (7 days)
- •Leukotriene inhibitors (14 days)
- •Oral antibiotics for Respiratory tract infections (14 days)
- •Cromolyn compounds, all mast cell stabilizers (14 days)
- •Ephedrine or pseudoephedrine containing products (5 days)
- •Decongestants including cold preparations (5 days)
- •Traditional Chinese Medicines (TCM) for treatment of AR with known active ingredient, e.g. antihistamines, ephedrine or pseudoephedrine, (5 days)
- •TCM for treatment of AR with unknown active ingredient (14 days)
- •Tricyclic antidepressants (30 days)
- •Monoamine oxidase inhibitors (14 days)
- •Immunosuppressives/immunomodulators, e.g., anti-tumour necrosis factor (TNF) agents (30 days)
- •IgE antagonist or other biologics (130 days)
- •Administrative reasons:
- •- Participants anticipating significant changes in their daily environmental exposure (e.g. travel more than 3 days).
研究组 & 干预措施
Treatment with intranasal spray of Dymista
The study drug will be delivered as an intranasal spray of Dymista (137 μg of azelastine hydrochloride and 50 μg of fluticasone propionate) in each nostril, BID, approximately 12 hours apart at AM and PM. The formulation is a white suspension which contains 120 sprays per bottle. The liquid medicine is sprayed out in a mist after actuator is pressed.
干预措施: Treatment with 137 µg azelastine hydrochloride and 50 μg of fluticasone propionate (Drug)
结局指标
主要结局
Change from baseline in AM+PM combined reflective Total Nasal Symptom Score (rTNSS).
时间窗: From enrollment to end of treatment at 2 weeks.
Least Sqares (LS) mean change from baseline over 14 days (Day 2 to Day 14) in AM+PM combined rTNSS after treatment with Dymista nasal spray regardless of discontinuation for any reason or low compliance (treatment policy strategy). Explanation of rTNSS scale and score: The reflective Total Nasal Symptom Score (TNSS) evaluates nasal symptoms associated with AR. It includes four nasal symptoms: nasal itching, nasal congestion, runny nose (rhinorrhea) and sneezing. The symptom severity is scored on a four-point scale \[0-3\] for each symptom, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The severity of each symptom is assessed to arrive at the total TNSS score, which ranges from 0 to 12. Hence, the AM + PM combined TNSS ranges from 0 to 24.
次要结局
- Changes from baseline in AM+PM combined reflective TOSS(From enrollment to the end of treatment at 2 weeks.)
- Changes from baseline in AM+PM combined reflective T7SS(From enrollment to the end of treatment at 2 weeks.)
- Changes from baseline in individual nasal symptom scores (itchy nose, nasal congestion, runny nose, sneezing) and ocular symptom scores (itchy eyes, watery eyes, eye redness)(From enrollment to the end of treatment at 2 weeks.)