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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011709
Recruitment Status : Completed
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Vectura Limited

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 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.


Condition or disease Intervention/treatment Phase
Cough Wheezing Combination Product: VR647 Inhalation System + VR647 Smart Card 3 Secs Combination Product: VR647 Inhalation System + VR647 Smart Card 2 Secs Combination Product: VR647 Inhalation System + VR647 Smart Card 4 Secs Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
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
Official Title: 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
Actual Study Start Date : November 3, 2017
Actual Primary Completion Date : February 20, 2018
Actual Study Completion Date : February 20, 2018

Arm Intervention/treatment
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
Combination Product: VR647 Inhalation System + VR647 Smart Card 3 Secs
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)

Combination Product: VR647 Inhalation System + VR647 Smart Card 2 Secs
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)

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
Combination Product: VR647 Inhalation System + VR647 Smart Card 3 Secs
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)

Combination Product: VR647 Inhalation System + VR647 Smart Card 4 Secs
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)




Primary Outcome Measures :
  1. Number of subjects achieving nebulization success using a mouthpiece overall and by age (years) at each visit. [ Time Frame: 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.


Secondary Outcome Measures :
  1. Number of breaths completed by subjects using a mouthpiece overall and by age (years) at each visit. [ Time Frame: 4 to 8 days ]
    Number of breaths completed by subjects using a mouthpiece recorded at each visit.

  2. Number of subjects aged 3 to <5 years who require parent(s)/legal guardian(s) hands-on assistance at Attempt 3 at each visit. [ Time Frame: 4 to 8 days ]
    Number of subjects aged 3 to <5 years who require parent(s)/legal guardian(s) hands-on assistance as assessed (Yes/No) by the Investigator on the inhalation checklist.

  3. Number of subjects who require parent(s)/legal guardian(s) hands-on assistance at Attempt 3 overall and by age (years) at each visit. [ Time Frame: 4 to 8 days ]
    Number of subjects who require parent(s)/legal guardian(s) hands-on assistance as assessed (Yes/No) by the Investigator on the inhalation checklist.

  4. The quality of nebulization at Attempt 3 as recorded in the inhalation checklist overall and by age (years) at each visit. [ Time Frame: 4 to 8 days ]
    The inhalation checklist consists of 5 questions regarding inhalation quality answered Yes/No (Q1, Q2, Q3 and Q5) or by percentage (Q4), with Yes answers for Q1-3 and >50% for Q4 (or Yes answers for Q1-3 and Q5 in the successful subgroup analysis) being scored as perfect.

  5. Mean modified Patient Satisfaction and Preference Questionnaire (PASAPQ) total score at Attempt 3 at Visit 2 overall and by age (years). [ Time Frame: 4 to 8 days ]
    The PASAPQ is a validated multi-item measure of satisfaction and preference with inhaler devices. The modified PASAPQ consists of 10 questions. The first 8 questions generate the total score domain (scale: 1 (i.e., very dissatisfied) to 7 (i.e., very satisfied); range: 14.3 to 100, calculated as ((Q1+Q2+Q3+Q4+Q5+Q6+Q7+Q8)/56)*100).

  6. Mean modified PASAPQ satisfaction score at Attempt 3 at Visit 2 overall and by age (years). [ Time Frame: 4 to 8 days ]
    The PASAPQ is a validated multi-item measure of satisfaction and preference with inhaler devices. The modified PASAPQ consists of 10 questions. Question 9 asks for overall satisfaction with the device(s) used in the trial (scale: 1 (i.e., very dissatisfied) to 7 (i.e., very satisfied); range: 1-7).

  7. Mean modified PASAPQ score indicating willingness to continue with the device at Attempt 3 at Visit 2 overall and by age (years). [ Time Frame: 4 to 8 days ]
    The PASAPQ is a validated multi-item measure of satisfaction and preference with inhaler devices. The modified PASAPQ consists of 10 questions. Question 10 asks about willingness to continue with the device(s) used in the trial (scale: 0 (i.e, not willing) to 100 (i.e., definitely willing; range: 0-100).



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011709


Locations
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United States, California
Allergy & Asthma Associates of Southern California
Mission Viejo, California, United States, 92691
United States, Minnesota
Clinical Research Institute, Inc
Plymouth, Minnesota, United States, 55441
United States, Missouri
St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
United States, North Carolina
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27607
United States, South Carolina
National Allergy and Asthma Research, LLC
Charleston, South Carolina, United States, 29407
Sponsors and Collaborators
Vectura Limited
Investigators
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Study Director: Gary Burgess, MD Vectura Ltd
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Responsible Party: Vectura Limited
ClinicalTrials.gov Identifier: NCT04011709    
Other Study ID Numbers: VR647/0/003
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vectura Limited:
Nebulizer
Pediatric
Methodological study
Additional relevant MeSH terms:
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Respiratory Sounds
Signs and Symptoms, Respiratory