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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-18

Study Completion Date

2018-03-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Wheezing Reactive Airway Disease Mild Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is an open label, randomized, balanced, incomplete block design trial. Eligible subjects will be randomized to 1 of 12 treatment sequences (A,B), (A,C), (A,D), (B,A), (B,C), (B,D), (C,A), (C,B), (C,D), (D,A), (D,B) or (D,C), corresponding to the following treatment regimens:

* (A) 5 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System
* (B) 10 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System
* (C) 20 breaths of VR647 Inhalation Suspension delivered by the VR647 Inhalation System
* (D) 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer nebulized to empty

The treatment period comprises 2 dosing visits. Each subject will receive their first treatment regimen during Visit 2 and their second treatment regimen during Visit 3.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

This is an open label trial.

Study Groups

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AB - VR647 5 breaths, then VR647 10 breaths

5 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System followed by 10 breaths of the VR647 Inhalation Suspension 1 mg/2 mL delivered by the VR647 Inhalation System

Group Type EXPERIMENTAL