An Open-label, Non-drug Methodology Trial to Evaluate the Use of a Mouthpiece With the VR647 Inhalation System During Delivery of Isotonic Saline (0.9% NaCl) in Subjects Less Than Five Years of Age Who Have Previously Received an Inhaled Therapy Delivered Either by a Nebulizer or by a Pressurized Metered-dose Inhaler Plus Spacer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 10
- 主要终点
- Number of subjects achieving nebulization success using a mouthpiece overall and by age (years) at each visit.
研究概览
简要总结
This is an open-label, non-drug methodology trial in which subjects undergo a stepwise series of tests to evaluate their ability to use a mouthpiece to deliver nebulized therapy.
The trial consists of a screening assessment and familiarization session, and two nebulization assessments, conducted over two site visits. The screening assessment, familiarization session and first nebulization assessment will take place at Visit 1, while the second nebulization assessment will take place at Visit 2. The total duration between Visits 1 and 2 will be 4 - 8 days. Each visit is expected to last up to 2 hours.
详细描述
At the initial visit (Visit 1), eligible subjects (i.e., children) and their parent(s)/legal guardian(s) will be approached to ascertain their interest in trial participation. Interested subjects and their parent(s)/legal guardian(s) will proceed to a nebulizer familiarization session. After informed consent has been obtained from the subject's parent(s)/legal guardian(s), the subject will proceed to Nebulization Assessment 1.
At Nebulization Assessment 1 (Visit 1), all subjects will perform 3 attempts of 19 inhalations, each inhalation of 3 seconds duration. Nebulization Assessment 2 (Visit 2) will occur 4-8 days after Visit 1. Subjects, who failed to achieve nebulization success at Attempt 3 during Visit 1, will perform 3 attempts of 28 inhalations, each inhalation of 2 seconds duration at Visit 2. Subjects, who achieved nebulization success at Attempt 3 during Visit 1, will perform 3 attempts of 14 inhalations, each inhalation of 4 seconds duration at Visit 2.
At each visit, Attempts 1 and 2 will be made with air only. Attempt 3 will be made with isotonic saline (0.9% NaCl). Nebulization success will be assessed at Attempt 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged 1 to <5 years
- •History of coughing and/or recurrent wheezing within the last year, otherwise healthy
- •Use of an inhaler with a spacer or nebulizer for at least 30 days (consecutive or otherwise) within the last year. Examples of inhaled or nebulized therapy include the use of a regular controller (inhaled corticosteroids (ICS) or ICS/long-acting beta-agonists), or a reliever therapy (e.g., albuterol) on an as needed basis for the relief of symptoms
- •Written informed consent from the subjects's parent(s)/legal guardian(s), including privacy authorization, prior to trial participation
- •Subject's parent(s)/legal guardian(s) must be willing and able to comply with the trial procedures and visit schedules
排除标准
- •Screening (Visit 1)
- •Any significant medical conditions (apart from a history of coughing and/or recurrent wheezing) that in the opinion of the investigator would interfere with the subject's ability to use the mouthpiece and/or follow the protocol procedures
- •Subjects with current respiratory symptoms or breathing difficulties at the time of screening
- •History of paradoxical bronchospasm or hyper-responsiveness following inhaled therapy that in the opinion of investigator may put the subject at risk when inhaling isotonic saline
- •Parent(s)/legal guardian(s) who is an employee of the investigational site or the Sponsor, who is directly involved in the trial, or a family member of such a person
- •Nebulization Assessment 2 (Visit 2)
- •Development of any new illness or condition between the Screening (Visit 1) and prior to Nebulization Assessment 2 (Visit 2) that in the opinion of the investigator would interfere with the subject's ability to use the mouthpiece and/or follow the protocol procedures
- •Any safety concerns that in the opinion of the investigator would jeopardize the subject by his/her continued participation in the trial
研究组 & 干预措施
Visit 1 and Visit 2, Test Arm 2A
Subjects who carried out 3 attempts at Visit 1, failed to achieve nebulization success and subsequently were included in Test Arm 2A for Visit 2
干预措施: VR647 Inhalation System + VR647 Smart Card 3 Secs (Combination Product)
Visit 1 and Visit 2, Test Arm 2A
Subjects who carried out 3 attempts at Visit 1, failed to achieve nebulization success and subsequently were included in Test Arm 2A for Visit 2
干预措施: VR647 Inhalation System + VR647 Smart Card 2 Secs (Combination Product)
Visit 1 and Visit 2, Test Arm 2B
Subjects who carried out 3 attempts at Visit 1, achieved nebulization success and were subsequently included in Test Arm 2B for Visit 2
干预措施: VR647 Inhalation System + VR647 Smart Card 3 Secs (Combination Product)
Visit 1 and Visit 2, Test Arm 2B
Subjects who carried out 3 attempts at Visit 1, achieved nebulization success and were subsequently included in Test Arm 2B for Visit 2
干预措施: VR647 Inhalation System + VR647 Smart Card 4 Secs (Combination Product)
结局指标
主要结局
Number of subjects achieving nebulization success using a mouthpiece overall and by age (years) at each visit.
时间窗: 4 to 8 days
Nebulization success using a mouthpiece defined as actuating the nebulizer on at least 70% of planned inhalations and inhaling at least 50% of the total intended inhalation volume.
次要结局
- Mean modified Patient Satisfaction and Preference Questionnaire (PASAPQ) total score at Attempt 3 at Visit 2 overall and by age (years).(4 to 8 days)
- Number of subjects aged 3 to <5 years who require parent(s)/legal guardian(s) hands-on assistance at Attempt 3 at each visit.(4 to 8 days)
- Mean modified PASAPQ score indicating willingness to continue with the device at Attempt 3 at Visit 2 overall and by age (years).(4 to 8 days)
- Number of breaths completed by subjects using a mouthpiece overall and by age (years) at each visit.(4 to 8 days)
- Number of subjects who require parent(s)/legal guardian(s) hands-on assistance at Attempt 3 overall and by age (years) at each visit.(4 to 8 days)
- The quality of nebulization at Attempt 3 as recorded in the inhalation checklist overall and by age (years) at each visit.(4 to 8 days)
- Mean modified PASAPQ satisfaction score at Attempt 3 at Visit 2 overall and by age (years).(4 to 8 days)