Safety and Pharmacokinetics of Halix(TM) Albuterol Unit Dose Disposable Inhaler Versus Albuterol MDI
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      Healthy male and female volunteers without asthma will be recruited to enroll in a single
      dose 3-way crossover study of the safety and pharmacokinetics of albuterol when administered
      using the Halix (TM) albuterol unit dose disposable dry powder inhaler (DPI) and the
      albuterol HFA (hydrofluoroalkane) MDI inhaler.
    

Detailed description: 
      The study objective is to compare the safety of albuterol in a dry powder inhaler (DPI) and
      albuterol in an HFA metered dose inhaler (MDI) after single albuterol doses of 90mcg and
      180mcg delivered by the DPI and 180mcg delivered by the MDI. Another study objective is to
      compare the pharmacokinetics (metabolism) of albuterol with the two inhalers in all subjects
      treated. To participate in the study, subjects must provide written informed consent, washout
      any prohibited medications and pass all the screening criteria. Once this is done, there will
      be 3 treatment visits for each subject. At each of these visits, the subject will inhale from
      either the DPI or the MDI. Assignment of subjects to one of six (6) unique sequences of
      treatment will be according to a randomized scheme. The subject will inhale albuterol either
      once from the DPI (90mcg), twice from the DPI (180mcg) and twice from the MDI (180mcg).
      Following inhalation of the study drug, there will be a series of assessments taken at times
      postdose with spirometry (FEV1) measured up to 2 hours postdose, vital signs measured up to
      10 hours post dose, ECGs obtained up to 5 hours postdose, blood taken to measure potassium
      and glucose up to 6 hours postdose, and blood for pharmacokinetic evaluation obtained up to
      10 hours postdose. A washout period of 60 to 192 hours will separate each of the 3 treatment
      visits. Following these visits, there will be a study concluding visit 3 to 10 days later.
    

Intervention name(s): Albuterol DPI 90mcg; Albuterol DPI 180mcg; Albuterol HFA MDI
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Albuterol unit dose disposable DPI delivers 90mcg of albuterol in the excipient lactose with each inhalation. Albuterol 90mcg will be given on one of the 3 treatment days. One inhalation from the DPI will be used.; Albuterol unit dose disposable DPI delivers 90mcg of albuterol in the excipient lactose with each inhalation. Albuterol 180mcg will be given on one of the 3 treatment days. Two inhalations from the DPI will be used to deliver the 180mcg dose; Albuterol HFA MDI delivers 90mcg of albuterol with each inhalation. Albuterol 180mcg will be given on one of the 3 treatment days. Two inhalations from the MDI will be used to deliver the 180mcg dose
Other intervention name(s): Halix (TM) albuterol unit dose disposable inhaler; Halix (TM) albuterol unit dose disposable inhaler; Ventolin HFA MDI
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 3-way single dose crossover
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dry Powder Inhaler