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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Vectura Limited · Industry
• Sex: All
• Age: 4 Years – 8 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wheezing
• Reactive Airway Disease
• Mild Asthma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System	The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial.
COMBINATION_PRODUCT	1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer	Commercial Pulmicort Respules (budesonide inhalation suspension 1 mg/2 mL) delivered by a conventional jet nebulizer operated to sputtering.

Timeline

• Start date: 2017-12-18
• Primary completion: 2018-03-21
• Completion: 2018-03-27
• First posted: 2018-02-05
• Last updated: 2019-10-21
• Results posted: 2019-10-21

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study