NCT04032834

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

A Randomized, Open-label, Crossover Trial to Compare the Pharmacokinetics, Safety and Tolerability of Single Doses of VR647 Inhalation Suspension Delivered by the VR647 Inhalation System (VR647) With Single Doses of Budesonide Delivered by a Conventional Jet Nebulizer in Healthy Adult Volunteers and Adult Asthma Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Vectura Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

• Asthma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece	The VR647 Inhalation System consists of the AKITA JET control unit that has an inspiration flow rate of 12 L/min, an AKITA JET nebulizer handset, a mouthpiece and dose-specific VR647 Smart Cards designed specifically for this trial.
COMBINATION_PRODUCT	VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask	The VR647 Inhalation System consists of the AKITA JET control unit that has an inspiration flow rate of 12 L/min, an AKITA JET nebulizer handset, a facemask and dose-specific VR647 Smart Cards designed specifically for this trial.
COMBINATION_PRODUCT	1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece	Commercial Pulmicort Respules (budesonide inhalation suspension 1 mg/2 mL) will be delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece operated to sputtering.
COMBINATION_PRODUCT	1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask	Commercial Pulmicort Respules (budesonide inhalation suspension 1 mg/2 mL) will be delivered by a conventional jet nebulizer (PARI VIOS) with facemask operated to sputtering.
COMBINATION_PRODUCT	0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece	Commercial Pulmicort Respules (budesonide inhalation suspension 0.5 mg/2 mL) will be delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece operated to sputtering.
COMBINATION_PRODUCT	0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask	Commercial Pulmicort Respules (budesonide inhalation suspension 0.5 mg/2 mL) will be delivered by a conventional jet nebulizer (PARI VIOS) with facemask operated to sputtering.

Timeline

• Start date: 2017-02-20
• Primary completion: 2017-05-22
• Completion: 2017-05-22
• First posted: 2019-07-25
• Last updated: 2019-07-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study