A Methodology Trial Using the VR647 Inhalation System in Pediatric Subjects Who Have Previously Received Inhaled Therapy

Completed · Early Phase 1

Conditions studied: Cough, Wheezing

In brief

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.

Key facts

Study ID

NCT04011709

Run by

Vectura Limited

People needed

41

Starts

2017-11-03

Expected to finish

2018-02-20

Last updated by the study team

2019-07-08

Who can join

Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Allergy & Asthma Associates of Southern California — Mission Viejo, California, United States
• Clinical Research Institute, Inc — Plymouth, Minnesota, United States
• St. Louis Children's Hospital — St Louis, Missouri, United States
• North Carolina Clinical Research — Raleigh, North Carolina, United States
• National Allergy and Asthma Research, LLC — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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