A Methodology Trial Using the VR647 Inhalation System in Pediatric Subjects Who Have Previously Received Inhaled Therapy
Condition: Cough; Wheezing
MeSH terms: Respiratory Sounds
Study type: Interventional
Phase: Early Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): VR647 Inhalation System + VR647 Smart Card 3 Secs; VR647 Inhalation System + VR647 Smart Card 2 Secs; VR647 Inhalation System + VR647 Smart Card 4 Secs
Intervention type(s): Combination Product; Combination Product; Combination Product
Intervention description(s): 3 attempts of 19 inhalations, 3 second per breath. Attempts 1 and 2 will be made with air only. Attempt 3 will be made with isotonic saline (0.9% NaCl); 3 attempts of 28 inhalations, 2 second per breath. Attempts 1 and 2 will be made with air only. Attempt 3 will be made with isotonic saline (0.9% NaCl); 3 attempts of 14 inhalations, 4 second per breath. Attempts 1 and 2 will be made with air only. Attempt 3 will be made with isotonic saline (0.9% NaCl)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This open-label, non-drug methodology trial consists of a screening assessment, familiarization session and a nebulization assessment at one visit and a second nebulization assessment at a second visit.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Nebulizer; Pediatric; Methodological study