Status:
COMPLETED
A Methodology Trial Using the VR647 Inhalation System in Pediatric Subjects Who Have Previously Received Inhaled Therapy
Lead Sponsor:
Vectura Limited
Conditions:
Cough
Wheezing
Eligibility:
All Genders
1-5 years
Phase:
EARLY_PHASE1
Brief 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 o...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2018
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04011709
Start Date
November 3 2017
End Date
February 20 2018
Last Update
July 8 2019
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Allergy & Asthma Associates of Southern California
Mission Viejo, California, United States, 92691
2
Clinical Research Institute, Inc
Plymouth, Minnesota, United States, 55441
3
St. Louis Children's Hospital
St Louis, Missouri, United States, 63110
4
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27607