A Cumulative Dose Study to Evaluate the Safety and Efficacy of Albuterol in a Dry Powder Inhaler and an HFA MDI (Hydrofluoroalkane Metered Dose Inhaler)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will measure the improvement in lung function in subjects with asthma after
      inhaling from two inhalers, Albuterol in a dry powder inhaler and albuterol in an HFA
      (hydrofluoroalkane), metered dose inhaler.
    

Detailed description: 
      The study objective is to compare the efficacy and safety of albuterol in a dry powder
      inhaler (DPI) and albuterol in an HFA metered dose inhaler (MDI) after a cumulative dose of
      1440mcg administered as 1+1+2+4+8 inhalations (90mcg per inhalation). Another study objective
      is to compare the pharmacokinetics (metabolism) of albuterol with the two inhalers. The
      pharmacokinetics of albuterol will be examined in half (24) of the study subjects. To
      participate in the study, patients must provide written informed consent, washout any
      prohibited medications and pass all the screen criteria. Once this is done, there will be two
      treatment visits. At each visit the subject will inhale with both types of inhalers. At each
      visit, one inhaler will have active drug (albuterol) and one inhaler will have placebo
      (dummy). The inhaler with the active drug will be switched at the two visits in a random
      manner. At each visit the subject will inhale with each inhaler a total of 16 times by a
      specific schedule. The subject will inhale from each inhaler once (1), wait 30 minutes,
      inhale from each inhaler once (1), wait 30 minutes, inhale from each inhaler twice (2), wait
      30 minutes, inhale from each inhaler four times (4), wait 30 minutes, and then inhale from
      each inhaler eight times (8). The total time to complete the inhalations should be about 2
      hours. Following that, there will be a series of assessments taken at regular times with
      vital signs measured up to 6 hours, ECG (electrocardiogram) assessed up to 4 hours, blood
      taken to measure potassium and glucose up to 4 hours, lung function evaluated with spirometry
      up to 6 hours, and for those subjects participating in the pharmacokinetic evaluation blood
      will be drawn up to 12 hours. The two study treatment visits will be 3 to 14 days apart.
      Following these visits, there will be a study concluding visit 1 to 5 days later.
    

Intervention name(s): Albuterol dry powder inhaler; Albuterol HFA MDI (hydrofluoroalkane metered dose inhaler)
Intervention type(s): Drug; Drug
Intervention description(s): Albuterol DPI (dry powder inhaler) delivers 90mcg of albuterol in the excipient lactose with each inhalation. Albuterol will be given on two treatment days (3 to 14 days apart). On each treatment day albuterol will be given as a cumulative dose of 1440mcg as a series of inhalations using both Albuterol in a DPI (dry Powder inhaler) and albuterol in an HFA MDI (hydrofluoroalkane metered dose inhaler), ProAir. One inhaler will contain active drug and one inhaler will contain placebo.; Albuterol HFA MDI (hydrofluoroalkane metered dose inhaler) delivers 90mcg of albuterol with each inhalation. Albuterol will be given on two treatment days (3to 14 days apart). On each treatment day albuterol will be given as a cumulative dose of 1440mcg as a series of inhalations using both Albuterol DPI (dry powder inhaler) and the comparator inhaler, albuterol HFA MDI (hydrofluoroalkane metered dose inhaler).One inhaler will contain active drug and one inhaler will contain placebo.
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: asthma; dry powder inhaler; short-acting beta2-agonist; SABA; bronchoconstriction; bronchodilation; bronchodilator; metered dose inhaler