NCT04011709

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Nov 2017

Shorter than P25 for early_phase_1

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 8, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

June 17, 2019

Last Update Submit

July 4, 2019

Conditions

CoughWheezing

Keywords

NebulizerPediatricMethodological study

Outcome Measures

Primary Outcomes (1)

  • Number of subjects achieving nebulization success using a mouthpiece overall and by age (years) at each visit.

    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.

    4 to 8 days

Secondary Outcomes (7)

  • Number of breaths completed by subjects using a mouthpiece overall and by age (years) at each visit.

    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

  • 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 Patient Satisfaction and Preference Questionnaire (PASAPQ) total score at Attempt 3 at Visit 2 overall and by age (years).

    4 to 8 days

  • +2 more secondary outcomes

Study Arms (2)

Visit 1 and Visit 2, Test Arm 2A

OTHER

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 SecsCombination Product: VR647 Inhalation System + VR647 Smart Card 2 Secs

Visit 1 and Visit 2, Test Arm 2B

OTHER

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 SecsCombination Product: VR647 Inhalation System + VR647 Smart Card 4 Secs

Interventions

VR647 Inhalation System + VR647 Smart Card 3 SecsCOMBINATION_PRODUCT

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)

Visit 1 and Visit 2, Test Arm 2AVisit 1 and Visit 2, Test Arm 2B
VR647 Inhalation System + VR647 Smart Card 2 SecsCOMBINATION_PRODUCT

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 2A
VR647 Inhalation System + VR647 Smart Card 4 SecsCOMBINATION_PRODUCT

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)

Visit 1 and Visit 2, Test Arm 2B

Eligibility Criteria

Age1 Year - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Allergy & Asthma Associates of Southern California

Mission Viejo, California, 92691, United States

Location

Clinical Research Institute, Inc

Plymouth, Minnesota, 55441, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

North Carolina Clinical Research

Raleigh, North Carolina, 27607, United States

Location

National Allergy and Asthma Research, LLC

Charleston, South Carolina, 29407, United States

Location

MeSH Terms

Conditions

CoughRespiratory Sounds

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Gary Burgess, MD

    Vectura Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2019

First Posted

July 8, 2019

Study Start

November 3, 2017

Primary Completion

February 20, 2018

Study Completion

February 20, 2018

Last Updated

July 8, 2019

Record last verified: 2019-07

Locations

US(5)