Clinical Trials Logo
  1. Home
  2. Mild Asthma
  3. NCT03421730

A Study of the Pharmacokinetics, Safety and Tolerability of Single Doses of VR647 Inhalation Suspension Administered Using the VR647 Inhalation System in Children With Wheezing, Reactive Airway Disease or Mild Asthma

Wheezing Clinical Trial

Official title:
A Single-dose, Open-label, Randomized, Incomplete Block Design Trial to Characterize the Pharmacokinetics of VR647 Inhalation Suspension Delivered by the VR647 Inhalation System and Single Doses of Budesonide Delivered by a Conventional Jet Nebulizer in Pediatric Subjects Aged 4 to 8 Years With Wheezing, Reactive Airway Disease or Mild Asthma

Clinical Trial Summary

The primary objective of this study is to evaluate budesonide levels in the blood following inhalation of single doses of VR647 Inhalation Suspension in children with wheezing, reactive airway disease or mild asthma using a nebulizer, the VR647 Inhalation System. Secondary objectives include the evaluation of the safety and tolerability of VR647 Inhalation Suspension administered using the VR647 Inhalation System.

The study consists of four visits; a screening visit (Visit 1), two dosing days (Visits 2 and 3) and a follow-up visit (Visit 4). On each dosing day a single dose of treatment will be administered. Treatment allocation at Visits 2 and 3 is determined by a balanced incomplete block design.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03421730
Study type Interventional
Source Vectura Limited
Contact
Status Completed
Phase Phase 1
Start date December 18, 2017
Completion date March 27, 2018
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04669288 - AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department Phase 3
Withdrawn NCT04584034 - Bronchodilators for Wheeze in Young Children Presenting to Primary Care: a Randomised, Placebo-controlled, Multicentre, Parallel Group Trial Phase 4
Terminated NCT02269761 - Chest Ultrasound of ER Patients With Cough or SOB
Enrolling by invitation NCT00775697 - Montelukast in Children With Wheezing Phase 4
Completed NCT00749528 - Evaluation of Toxic Metals, Trace Elements and Total Antioxidant Activity in Children With Recurrent Wheezing N/A
Recruiting NCT00494624 - Efficacy of Systemic Glucocorticoid in the Treatment of Wheezing in Children Phase 4
Recruiting NCT04128592 - Non-invasive Differential Diagnosis of Noisy Breathing Infants and Toddlers N/A
Recruiting NCT06093152 - Video Assisted Study of Salbutamol Response in Viral Wheezing
Completed NCT01452945 - Bedside Lung Ultrasound in Young Children Presenting to the Emergency Department (ED) With Wheezing N/A
Withdrawn NCT00628303 - A Phase 3 Trial of the Effect of Motavizumab Prophylaxis on Reduction of Serious Early Childhood Wheezing in Infants Phase 3
Completed NCT01028560 - Allergy Immunotherapy for the Reduction of Asthma Phase 1/Phase 2
Completed NCT00626808 - A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children Phase 4
Completed NCT00507676 - Lung Function and Structure in Healthy Infants and Infants With Recurrent Wheezing N/A
Completed NCT03600428 - Safety of LAIV4 in Children With Asthma Phase 4
Recruiting NCT06106646 - Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) Longer Term Follow Up
Recruiting NCT05710081 - Bacterial Lysate In Preventing Asthma Phase 3
Completed NCT04011709 - A Methodology Trial Using the VR647 Inhalation System in Pediatric Subjects Who Have Previously Received Inhaled Therapy Early Phase 1
Active, not recruiting NCT03377192 - Impedance Pneumography in Assessment of Asthma Control in Preschool Children
Completed NCT01142505 - Wheeze and Intermittent Treatment Phase 3
Active, not recruiting NCT04942483 - Using Specific Tests in Preschool Children With Wheeze to Help us Determine the Necessity of Inhaled Corticosteroid Therapy (Feasibility Study).