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

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.