NCT03421730View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

December 18, 2017

Primary Completion Date

March 21, 2018

Study Completion Date

March 27, 2018

Conditions
WheezingReactive Airway DiseaseMild Asthma
Interventions
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.

Trial Locations (3)

27607

Vectura Study Site 0002, Raleigh

74136

Vectura Study Site 0001, Tulsa

80907

Vectura Study Site 0003, Colorado Springs

All Listed Sponsors
lead

Vectura Limited

INDUSTRY

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 | Biotech Hunter | Biotech Hunter