Open-Label Assessment of the Albuterol Spiromax® Dry Powder Inhaler (DPI)
Condition: Asthma; Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Albuterol Spiromax®
Intervention description: Albuterol Spiromax delivers 90 mcg of albuterol base from the mouthpiece per triggered dose. Participants took doses of 2 inhalations each twice a day (morning and evening) for a total daily dose of 360 mcg. The first 45 enrolled participants constituted a subgroup who were dosed for 35 days, while most participants were dosed for 50 days.
Intervention MeSH terms: Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 317.0
Sex: All
Minimum age: 4 Years
Healthy volunteers: No
Keywords: asthma; chronic obstructive pulmonary disease; COPD; Albuterol Spiromax®

Summary:

      This is a prospective, open-label, multicenter Phase 3 study evaluating the performance of
      the Albuterol Spiromax dose counter in patients with a diagnosis of asthma and/or COPD. The
      purpose of this study is to evaluate the functionality, reliability, and accuracy of the
      Albuterol Spiromax inhaler integrated dose counter in a clinical setting.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Written informed consent/assent signed and dated by the patient and/or parent/legal
             guardian before conducting any study related procedure

          2. Male or female (non pregnant/non lactating) patients 4 years of age or older at the
             time of the screening visit (SV) who are able to understand English

          3. Females of childbearing potential (as judged by the investigator) currently using and
             will continue to use a medically reliable method of contraception for the entire study
             duration (e.g. oral, injectable, trans-cutaneous or implantable contraceptives or
             intrauterine devices or double-barrier protection). Females who are not sexually
             active must agree to use a medically reliable method of contraception should they
             become active during the course of the study. Women of childbearing potential, or less
             than 1 year postmenopausal, will require a negative urine pregnancy test at the SV.
             Female patients will be considered to be of non-child-bearing potential and will not
             require a urine pregnancy test if at least one of the following apply:a. before
             menarche; b. more than one year post-menopausal; c. had a hysterectomy, bilateral
             oophorectomy, salpingectomy, or tubal ligation; d. has congenital sterility

          4. General good health, defined as free of any concomitant conditions or treatment that
             could interfere with study conduct, influence the interpretation of study
             observations/results, or put the patient at increased risk during the study

          5. Has a physician diagnosis of asthma or COPD with symptoms of bronchoconstriction
             requiring the use of short-acting β2-agonists

          6. Current Therapy: The patient's current asthma/COPD controller treatment regimen has
             remained stable for at least four weeks prior to the SV

          7. Capable of understanding the requirements, risks, and benefits of study participation,
             and, as judged by the investigator, capable of giving informed consent/assent and
             being compliant with all study requirements (visits, record keeping, etc)

          8. Able to demonstrate satisfactory Spiromax inhaler use and technique.

        Exclusion Criteria:

          1. History of life-threatening asthma or COPD that is defined for this protocol as an
             asthma or COPD episode that required intubation and/or was associated with
             hypercapnea, respiratory arrest, or hypoxic seizures

          2. Culture-documented or suspected bacterial or viral infection of the upper or lower
             respiratory tract, sinus, or middle ear that is not resolved within 2 weeks of the SV;
             or that occurs between the SV and TV1

          3. Is being treated with a long-acting β2-agonist alone

          4. Any asthma exacerbation requiring oral corticosteroids within 2 months of SV and any
             COPD exacerbation requiring oral corticosteroids within 1 month of the SV. A patient
             must not have been hospitalized for asthma or COPD within 4 months prior to the SV.

          5. Historical or current evidence of a clinically significant disease including, but not
             limited to: cardiovascular (e.g., congestive heart failure, known aortic aneurysm,
             clinically significant cardiac arrhythmia or coronary heart disease, cerebrovascular
             accident), hepatic, renal, hematological, neuropsychological, endocrine (e.g.,
             uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease,
             Cushing's syndrome), and/or gastrointestinal (e.g., poorly-controlled peptic ulcer or
             gastroesophageal reflux disease [GERD]). Significant is defined as any disease that,
             in the opinion of the investigator, would put the safety of the patient at risk
             through participation, or which could affect the endpoint analysis if the
             disease/condition exacerbated during the study.

          6. Uncontrolled hypertension (systolic blood pressure [BP] ≥160 mmHg or diastolic BP >100
             mmHg)

          7. History of any adverse reaction, including immediate or delayed hypersensitivity to
             any β2-agonist, sympathomimetic drug, or any component of the Albuterol Spiromax DPI
             or rescue ProAir Hydrofluoroalkane (HFA) Metered-dose inhaler (MDI) formulation.

          8. Other exclusion criteria apply.