A Methodology Trial Using the VR647 Inhalation System in Pediatric Subjects Who Have Previously Received Inhaled Therapy
4 luglio 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
41
Fase
- Prima fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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California
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Mission Viejo, California, Stati Uniti, 92691
- Allergy & Asthma Associates of Southern California
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Minnesota
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Plymouth, Minnesota, Stati Uniti, 55441
- Clinical Research Institute, Inc
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Missouri
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Saint Louis, Missouri, Stati Uniti, 63110
- St. Louis Children's Hospital
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North Carolina
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Raleigh, North Carolina, Stati Uniti, 27607
- North Carolina Clinical Research
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South Carolina
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Charleston, South Carolina, Stati Uniti, 29407
- National Allergy and Asthma Research, LLC
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 1 anno a 5 anni (Bambino)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Altro: 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
|
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)
|
|
Altro: 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
|
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)
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of subjects achieving nebulization success using a mouthpiece overall and by age (years) at each visit.
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of breaths completed by subjects using a mouthpiece overall and by age (years) at each visit.
Lasso di tempo: 4 to 8 days
|
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.
Lasso di tempo: 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.
|
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.
Lasso di tempo: 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 to 8 days
|
|
The quality of nebulization at Attempt 3 as recorded in the inhalation checklist overall and by age (years) at each visit.
Lasso di tempo: 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.
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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).
Lasso di tempo: 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).
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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).
Lasso di tempo: 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).
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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).
Lasso di tempo: 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).
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4 to 8 days
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
3 novembre 2017
Completamento primario (Effettivo)
20 febbraio 2018
Completamento dello studio (Effettivo)
20 febbraio 2018
Date di iscrizione allo studio
Primo inviato
17 giugno 2019
Primo inviato che soddisfa i criteri di controllo qualità
4 luglio 2019
Primo Inserito (Effettivo)
8 luglio 2019
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 luglio 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
4 luglio 2019
Ultimo verificato
1 luglio 2019
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- VR647/0/003
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .