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

PHASE1CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

February 20, 2017

Primary Completion Date

May 22, 2017

Study Completion Date

May 22, 2017

Conditions
Asthma
Interventions
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.

Trial Locations (2)

85283

Celerion, Tempe

92801

Anaheim Clinical Trials, LLC, Anaheim

All Listed Sponsors
lead

Vectura Limited

INDUSTRY

NCT04032834 - A Comparison of VR647 and Conventionally Nebulized Budesonide in Healthy Volunteers and Adult Asthma Subjects | Biotech Hunter | Biotech Hunter