A Twelve Month Long Term Safety Study to Evaluate the Safety of Albuterol in a Dry Powder Inhaler With Both Repeated and as Needed Dosing
Condition: Asthma
MeSH terms: Asthma
Intervention: Placebo Spiromax; Albuterol Spiromax
Intervention description: Placebo as a dry-powder inhaled orally using the Spiromax inhaler. During the 12-week double-blind period, participants take two (2) inhalations four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.; Albuterol as a dry-powder inhaled orally using the Spiromax inhaler. Each inhalation delivers 90 micrograms (mcg). During the 12-week double-blind period, participants take two (2) inhalations four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total dose of 720 micrograms per day for those paricipants randomized to the Albuterol treatment arm.
The double-blind period is followed by a 40-week open-label period in which all study participants will take Albuterol Spiromax 90 micrograms (mcg)/inhalation as needed (PRN).
Intervention MeSH terms: Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 331.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: asthma; dry powder inhaler; short-acting beta2-agonist; SABA; bronchoconstriction; bronchodilation; bronchodilator; metered dose inhaler

Summary:

      This is a one-year study to look at the safety of a dry powder inhaler with albuterol. After
      a one-week run in, for the first 3 months subjects will use an inhaler with either albuterol
      or a dummy drug at regular times four times a day. Then for the last nine months of the
      study, all subjects will be given the albuterol dry powder inhaler and will use it only when
      needed to help with breathing problems. Subjects will need to keep a daily diary (both paper
      and electronic) throughout the study recording any inhaler use and health problems. There
      will be visits to the study doctor about once a month for a year. This study is intended to
      show that the albuterol dry powder inhaler works well and is safe for use over a long period
      of time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented history of persistent asthma with rescue use of albuterol on average of at
             least once/ week over the 4-weeks prior to screening.

          -  Female subjects who are of childbearing potential (as judged by the investigator) must
             be currently using and willing to continue to use a medically reliable method of
             contraception for the entire study duration

          -  General good health

          -  Capable of understanding the requirements, risks, and benefits of study participation

          -  Non-smoker for at least one year prior to the screening visit and a maximum pack-year
             smoking history of 10 years

          -  Other criteria apply

        Exclusion Criteria:

          -  Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for
             in vitro fertilization during the study period or for 30 days following the subject's
             last study related visit

          -  Participation in any investigational drug trial within 30 days preceding the screening
             visit

          -  A known hypersensitivity to albuterol or any of the excipients in the formulations.

          -  History of severe milk protein allergy

          -  History of a respiratory infection or disorder (including, but not limited to
             bronchitis, pneumonia, acute or chronic sinusitis, otitis media, influenza, etc) which
             is not resolved within 1 week prior to the Screening Visit.

          -  Use of any protocol prohibited concomitant medications for asthma or any protocol
             prohibited concomitant non-asthma medications

          -  Inability to tolerate or unwillingness to comply with the protocol requirements.

          -  History of life-threatening asthma

          -  Any asthma exacerbation within 3 months of the Screening Visit requiring oral or
             systemic corticosteroids

          -  History of life-threatening asthma

          -  Other criteria apply