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

Vectura Limited17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Wheezing Reactive Airway Disease Mild Asthma

Interventions

VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation SystemCOMBINATION_PRODUCT

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.

1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizerCOMBINATION_PRODUCT

Commercial Pulmicort Respules (budesonide inhalation suspension 1 mg/2 mL) delivered by a conventional jet nebulizer operated to sputtering.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 8 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: * Male or pre-menarchal female subjects. * Aged 4 to 8 years, inclusive. * Diagnosis of wheezing, reactive airway disease or mild asthma confirmed by a physician at least 3 months prior to screening. * Wheezing, reactive airway disease or mild asthma controlled by intermittent or regular non-steroidal medications commonly used for asthma, such as short-acting β2-agonists (SABAs) or leukotriene receptor antagonists (LTRAs), for a minimum of 28 days prior to the Screening Visit. * Body weight ≥15 kg. * Subject is able to demonstrate the ability to use the VR647 Inhalation System and the conventional jet nebulizer effectively during training. Key Exclusion Criteria: * Clinically relevant abnormality or medical condition (other than wheezing, reactive airway disease or mild asthma) identified at the screening assessment that, in the opinion of the investigator, could interfere with the objectives of the trial or the safety of the subject. The sponsor's medical officer should be consulted in case of any doubt. * Life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episodes. * Subjects currently using long-acting β2-agonists. * Use of the following prescription medications within 28 days prior to the first treatment day: corticosteroids by any route and drugs that inhibit cytochrome P450 3A4.

Locations (3)

Vectura Study Site 0003

Colorado Springs, Colorado, United States

Vectura Study Site 0002

Raleigh, North Carolina, United States

Vectura Study Site 0001

Tulsa, Oklahoma, United States

Outcomes

Primary Outcomes

AUClast of Plasma Budesonide (VR647 Inhalation Suspension Delivered by the VR647 Inhalation System or Pulmicort Respules Delivered by a Conventional Jet Nebulizer).

AUClast is the area under the plasma concentration-time curve, from time 0 to the time of the last measurable concentration (Clast).