A Comparison of VR647 and Conventionally Nebulized Budesonide in Healthy Volunteers and Adult Asthma Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-20

Study Completion Date

2017-05-22

Brief Summary

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This is a three part, randomized, open-label, crossover, Phase 1 trial in adults. Parts 1 and 2 will enroll healthy male and female subjects. Part 3 will enroll subjects with mild asthma. This study will assess the pharmacokinetics, safety and tolerability of single doses of budesonide delivered by VR647 Inhalation System (AKITA® JET) with mouthpiece or face mask to single doses of budesonide delivered by a conventional jet nebulizer (PARI VIOS®) with mouthpiece or face mask.

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Detailed Description

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For all parts of the study, subjects in the VR647 group will receive VR647 Inhalation Suspension delivered by the VR647 Inhalation System (AKITA JET) with either a mouthpiece or a facemask. Similarly, for all parts of the study, subjects in the comparator group will receive approved doses of budesonide (Pulmicort Respules®) delivered by a conventional jet nebulizer (PARI VIOS) with either a mouthpiece or a facemask.

Part 1:

Subjects who fulfill the enrollment criteria will progress to a comparative single dose, 6-treatment, 6-period crossover trial. Subjects will receive 4 dose levels of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (AKITA JET) (5, 10, 15 and 25 breaths, with targeted doses of 30, 60, 120 and 240 µg) and 2 dose levels of budesonide delivered by a conventional jet nebulizer (PARI VIOS) (0.5 and 1 mg). There will be a Washout Period between each dose of approximately 48 hours. Each subject will be randomized to treatment.

Part 2:

Following an approximate 7-day washout, the same cohort of subjects from Part 1 will progress to a comparative single dose, 6-treatment, 6-period crossover trial. There will be a Washout Period between each dose of approximately 48 hours. Each subject will be randomized to treatment in a 6-way crossover.

Part 3:

Subjects with mild asthma who fulfill the enrollment criteria (including those criteria specific to Part 3) will progress to a comparative single dose, 4-treatment, 4-period crossover trial conducted at a separate clinic from Parts 1 and 2. There will be a Washout Period between each dose of approximately 48 hours. This part of the trial can start before completion of Parts 1 and 2.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This is a three part, randomized, open-label, crossover, Phase 1 trial in adults. Parts 1 and 2 are comparative single dose, 6-treatment, 6-period crossover trials with a mouthpiece or facemask, respectively, in healthy adults. Subjects will receive 4 dose levels of VR647 Inhalation Suspension delivered by the VR647 Inhalation System (AKITA JET) (5, 10, 15 and 25 breaths, with a targeted doses of 30, 60 120 and 240 µg) and 2 dose levels of budesonide delivered by conventional jet nebulizer (PARI VIOS) (0.5 and 1 mg). Part 3 is a comparative single dose, 4-treatment, 4-period crossover trial in subjects with mild asthma. Subjects will receive doses of VR647 Inhalation Suspension (15 breaths, with a targeted dose of 120 µg) delivered by the VR647 Inhalation System (AKITA JET) with facemask or mouthpiece and budesonide (0.5 mg) delivered by conventional jet nebulizer (PARI VIOS) with facemask or mouthpiece.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1, Arm A of single-dose, 6-treatment, 6-period crossover

Subjects received the following treatments in Periods 1 to 6 in a crossover fashion: 5 breaths (30 µg) VR647, 10 breaths (60 µg) VR647, 15 breaths (120 µg) VR647, 25 breaths (240 µg) VR647, 0.5 mg budesonide, 1 mg budesonide.

Group Type OTHER