Safety Study of Albuterol Spiromax® in Subjects With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Placebo MDPI; Albuterol MDPI
Intervention description: Placebo MDPI (multi-dose dry powder inhaler) to match the active intervention.; Albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation.
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: 364.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety of Albuterol Spiromax® over 52 weeks
      during two dosing periods: (1) a 12-week, double-blind, placebo-controlled QID dosing period
      followed by (2) a 40-week, open-label PRN dosing period, and to evaluate Albuterol Spiromax®
      device performance through the life of the device during the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent and HIPAA signed and dated by the subject or written informed
             assent signed and dated both by the subject and/or parent/caregiver/legal guardian
             before conducting any study related procedure.

          -  Males or females with asthma ages 12 years or older at screening.

          -  Documented history of persistent asthma and current use of an MDI containing any
             short-acting beta-adrenergic agonist (e.g. albuterol, levalbuterol,) on average of at
             least once/week over the 4-weeks prior to screening. The asthma diagnosis must be
             consistent with the diagnosis of asthma as per the National Asthma Education and
             Prevention Program.

          -  If female, is currently not pregnant, breast feeding, or attempting to become pregnant
             (for 4 weeks before the screening visit and throughout the duration of the study), and
             is of Non-childbearing potential, defined as:

               -  ≥1 year post-menopausal or

               -  Surgically sterile (tubal ligation, bilateral oophorectomy, salpingectomy, or
                  hysterectomy) or is of

               -  Childbearing potential, has a negative serum pregnancy test, and is willing to
                  commit to using a consistent and acceptable method of birth control

          -  General good health in the opinion of the investigator as indicated by medical
             history, physical examination, laboratory tests (hematology, serum chemistry and
             urinalysis) assessed as either normal or abnormal not clinically significant (NCS) per
             the principal investigator, as well as a 12-lead ECG interpreted as either "Normal" or
             "Abnormal NCS" as determined by the central cardiologist. Subjects must also be free
             of any clinically significant, uncontrolled concomitant conditions other than asthma
             that could interfere with study conduct, influence the interpretation of study
             observations/results, or put the subject at increased risk during the trial.

          -  Capable of understanding the requirements, risks, and benefits of study participation,
             and, as judged by the investigator, and being compliant with all study requirements
             (visits, record-keeping, etc).

          -  Non-smoker for at least one year prior to the screening visit and a maximum pack-year
             (PY) smoking history of 10 years.

          -  Able to demonstrate proper inhaler technique with study inhaler.

        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 or planned participation in another investigational drug trial at any time
             during this trial.

          -  A known hypersensitivity to albuterol or any of the excipients in the formulations.

          -  History of severe milk protein allergy

          -  History of an upper or lower respiratory tract infection or disorder (including, but
             not limited to bronchitis, pneumonia, acute or chronic sinusitis, otitis media,
             influenza, etc) which is not resolved at least 1 week prior to the SV.

          -  History of alcohol or drug abuse within two years preceding the SV.

          -  Use of any protocol prohibited concomitant medications for asthma (any oral
             β2-adrenergic agonists) or any protocol prohibited concomitant non-asthma medications
             including treatment with β2-adrenergic receptor antagonists and non-selective
             β-receptor blocking agents such as β-blocking anti-hypertensive products (administered
             by any route), MAO inhibitors, and/or tricyclic antidepressants. (Subject's own MDI
             short-acting β-agonist rescue inhaler should be used until the start of the Run-In
             period when a study rescue inhaler is provided.)

          -  Inability or unwillingness to comply with the protocol requirements.

          -  History of life-threatening asthma [defined here as an asthma episode requiring
             intubation and/or associated with hypercapnea, respiratory arrest or hypoxic
             seizures.]

          -  Any asthma exacerbation within 3 months of the SV requiring oral or systemic
             corticosteroids or any hospitalization for asthma within 6 months of the SV.

        Note: An exacerbation of asthma is defined as any worsening of asthma requiring any
        treatment other than rescue albuterol or the subject's regular asthma maintenance therapy.
        This includes requiring the use of systemic corticosteroids and/or emergency room visit or
        hospitalization or a change in subject's regular asthma maintenance treatment. A subject
        does not need to be withdrawn from the study due to an asthma exacerbation unless
        hospitalization is required or unless the principal investigator believes it is in the
        subjects' best interest to withdraw from the study.

          -  Previous participation in an inhaled Albuterol Spiromax® (Teva) study, with the
             exception of the ABS-AS-306 study.

          -  Study participation by clinical investigator site employees and/or their immediate
             relatives.

          -  Study participation by related or non-related individuals living in the same
             household, i.e. only one subject per household may participate in the study.

          -  Any clinically significant endocrine, hematological, hepatic, renal, gastrointestinal,
             neurological, cardiac, metabolic, immunological, any non-asthmatic acute or chronic
             pulmonary condition (including but not limited to bronchitis, emphysema, active
             tuberculosis, bronchiectasis, cystic fibrosis), and malignancy other than basal cell
             carcinoma. Significant is defined for this protocol as any condition that, in the
             opinion of the investigator, would put the safety of the subject at risk through
             participation, or which could affect the safety analyses.

          -  Any medical or psychological condition that in the investigator's opinion should
             preclude enrollment.