A Methodology Trial Using the VR647 Inhalation System in Pediatric Subjects Who Have Previously Received Inhaled Therapy
2019. július 4. frissítette: Vectura Limited
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
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.
A tanulmány áttekintése
Állapot
Befejezve
Részletes leírás
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.
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
41
Fázis
- 1. korai fázis
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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California
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Mission Viejo, California, Egyesült Államok, 92691
- Allergy & Asthma Associates of Southern California
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Minnesota
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Plymouth, Minnesota, Egyesült Államok, 55441
- Clinical Research Institute, Inc
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Missouri
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Saint Louis, Missouri, Egyesült Államok, 63110
- St. Louis Children's Hospital
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North Carolina
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Raleigh, North Carolina, Egyesült Államok, 27607
- North Carolina Clinical Research
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South Carolina
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Charleston, South Carolina, Egyesült Államok, 29407
- National Allergy and Asthma Research, LLC
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
1 év (Gyermek)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
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
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Egyéb
- Kiosztás: Nem véletlenszerű
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Egyéb: 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
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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)
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Egyéb: 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
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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 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)
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Number of subjects achieving nebulization success using a mouthpiece overall and by age (years) at each visit.
Időkeret: 4 to 8 days
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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.
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4 to 8 days
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Number of breaths completed by subjects using a mouthpiece overall and by age (years) at each visit.
Időkeret: 4 to 8 days
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Number of breaths completed by subjects using a mouthpiece recorded at each visit.
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4 to 8 days
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Number of subjects aged 3 to <5 years who require parent(s)/legal guardian(s) hands-on assistance at Attempt 3 at each visit.
Időkeret: 4 to 8 days
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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.
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4 to 8 days
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Number of subjects who require parent(s)/legal guardian(s) hands-on assistance at Attempt 3 overall and by age (years) at each visit.
Időkeret: 4 to 8 days
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Number of subjects who require parent(s)/legal guardian(s) hands-on assistance as assessed (Yes/No) by the Investigator on the inhalation checklist.
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4 to 8 days
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The quality of nebulization at Attempt 3 as recorded in the inhalation checklist overall and by age (years) at each visit.
Időkeret: 4 to 8 days
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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.
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4 to 8 days
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Mean modified Patient Satisfaction and Preference Questionnaire (PASAPQ) total score at Attempt 3 at Visit 2 overall and by age (years).
Időkeret: 4 to 8 days
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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).
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4 to 8 days
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Mean modified PASAPQ satisfaction score at Attempt 3 at Visit 2 overall and by age (years).
Időkeret: 4 to 8 days
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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).
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4 to 8 days
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Mean modified PASAPQ score indicating willingness to continue with the device at Attempt 3 at Visit 2 overall and by age (years).
Időkeret: 4 to 8 days
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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).
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4 to 8 days
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Szponzor
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2017. november 3.
Elsődleges befejezés (Tényleges)
2018. február 20.
A tanulmány befejezése (Tényleges)
2018. február 20.
Tanulmányi regisztráció dátumai
Először benyújtva
2019. június 17.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2019. július 4.
Első közzététel (Tényleges)
2019. július 8.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2019. július 8.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2019. július 4.
Utolsó ellenőrzés
2019. július 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Kulcsszavak
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- VR647/0/003
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Nem
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