A Comparison of VR647 and Conventionally Nebulized Budesonide in Healthy Volunteers and Adult Asthma Subjects
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece; VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask; 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece; 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask; 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece; 0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask
Intervention type(s): Combination Product; Combination Product; Combination Product; Combination Product; Combination Product; Combination Product
Intervention description(s): 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.; 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.; 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.; 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.; 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.; 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.
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Budesonide; Nebulizer; Pharmacokinetics; AKITA JET