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

Cough Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04011709
Study type	Interventional
Source	Vectura Limited
Contact
Status	Completed
Phase	Early Phase 1
Start date	November 3, 2017
Completion date	February 20, 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00116337` - Spinal Cord Stimulation to Restore Cough	N/A
Not yet recruiting	`NCT04064333` - Slow-Stream Expiratory Muscle Strength Training for Veterans With Dysphagia Living in Long-term Care	N/A
Recruiting	`NCT02482818` - Efficacy of Pregabalin on Chronic Cough	Phase 1/Phase 2
Terminated	`NCT02269761` - Chest Ultrasound of ER Patients With Cough or SOB
Active, not recruiting	`NCT02065440` - The Effect of Ebastine/Pseudoephedrine on Subacute Cough	N/A
Completed	`NCT01071161` - The Effect of Azithromycin in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Chronic Productive Cough	Phase 3
Terminated	`NCT00668317` - Bronchial Hyper-responsiveness in Reflux Cough	Phase 3
Completed	`NCT00353951` - An Observational Study of Cough / Lower Respiratory Tract Infection (LRTI) in Primary Care	N/A
Completed	`NCT00287339` - The Utility of Nexium in Chronic Cough and Reflux Disease	Phase 4
Completed	`NCT00127686` - Effect of Honey and Dextromethorphan on Nocturnal Cough and Sleep	Phase 1
Recruiting	`NCT05115097` - AI Evaluation of COVID-19 Sounds (AI-EChOS)
Recruiting	`NCT04457011` - Efficacy and Safety of Susu Zhike Granules for Treating Acute Cough Due to Common Cold With Cold-cough Syndrome in Children	Phase 2
Recruiting	`NCT05042063` - Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease
Recruiting	`NCT03922373` - A Study of Benzonatate Soft Capsule in Chinese Healthy Subjects	Phase 1
Completed	`NCT05812209` - Stellate Ganglion Block to Treat Long COVID 19 Case Series
Recruiting	`NCT04767074` - A Non-pharmacological Cough Control Therapy	N/A
Recruiting	`NCT05570539` - Assessment of the Pharmacokinetics of BLU-5937 Extended Release Prototypes and a BLU-5937 Immediate Release Reference Formulation	Phase 1
Completed	`NCT03999203` - A Cross-sectional Study to Measure Cough in Severe Asthma	N/A
Active, not recruiting	`NCT05479929` - Work of Breathing Assessment in Triage Scale
Recruiting	`NCT02495571` - Assessment of Voluntary and Reflex Cough in Patients With ALS	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.