Open-Label Assessment of the Albuterol Spiromax® Dry Powder Inhaler (DPI)

A Prospective, Open-Label Assessment of the Albuterol Spiromax® DPI Integrated Dose Counter

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.

The study consists of a screening/run-in period where, after meeting study criteria, patients enter a run-in period lasting 7 to 14 ±2 days, during which diary and medication compliance, as well as inhaler technique, will be assessed. The run-in period will commence the day following the completion of all screening procedures and will continue through to and include the day prior to the first treatment visit (TV1) such that a minimum of 7 full days of diary data will be collected prior to TV1. The purpose of the run-in period is to assess compliance with a BID dosing regimen and with the completion of the diary entries over a minimum period of 7 days. Patients who demonstrate adequate inhaler technique and who are at least 90% compliant with dosing and completion of the diary on the last 7 consecutive days of run-in will qualify for enrollment into the open-label study. The study treatment period will comprise 6 treatment visits (TV1-TV6) for all enrolled patients except those in the 5-week treatment cohort who will have only 5 treatment visits (TV1-TV5). Patients may continue taking their current asthma or COPD medications throughout the Treatment Period. The patient will return to the clinic on Days 8 (±1), 15 (±1), 22 (±1), and 36 (±1), and then on Day 50 (-2) after approximately all 200 doses have been delivered, or until early withdrawal. The patient will be deemed to have completed the study if at least 90% of the recommended doses contained in Albuterol Spiromax with dose-counter were used. A representative sample (approximately 15%) of patients will participate in the trial for approximately 5 weeks with Day 36 (±1) being the final study visit.

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.