Safety and Efficacy of Albuterol Administered by the Halix™ Dry Powder Inhaler in Subjects With Asthma

Exclusion Criteria

• •1. Female subjects of childbearing potential (CBP) who are not using reliable contraception (e.g., abstinence, double barrier method, oral/implantable/transdermal contraception, Depo-Provera, intrauterine device, having one male sexual partner who has undergone vasectomy); a woman is of CBP unless she is premenarchal, is at least 2 years postmenopausal, is without a uterus and/or both ovaries, has had a bilateral tubal ligation, or has undergone the Essure procedure with confirmation of tubal blockage.
• •\[Note: If a female is identified as less than 2 years postmenopausal, a serum follicle-stimulating hormone (FSH) determination will be performed as a part of screening laboratory assessments. If an FSH result of \< 40 mIU/mL is obtained, the female will be determined to be of CBP and her unwillingness to use reliable contraception as defined above will be exclusionary for the study.\]
• •2. A woman who is pregnant (has a positive serum pregnancy test at Screening Visit), is lactating, or is likely/planning to become pregnant during the study
• •4. Chronic obstructive pulmonary disease or other significant lung disease (e.g. chronic bronchitis, emphysema, bronchiectasis with a need for treatment, cystic fibrosis, or bronchopulmonary dysplasia)
• •5. Oral corticosteroid use at any dose within the 6 weeks prior to the Screening Visit
• •6. Receipt of any marketed (e.g. omalizumab, mepolizumab, reslizumab) or investigational biologic within 3 months of the date of the Screening Visit or within 5 half-lives of the drug, whichever is longer
• •7. Currently a smoker, or a former smoker with \> 10 pack-year history, or a former smoker who stopped smoking \<1 year before the Screening Visit
• •8. A history of life-threatening asthma defined as any history of significant asthma episodes(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s)
• •9. Emergency room visit or hospitalization for any acute respiratory condition in the 3 months prior to the Screening Visit
• •10. Current history of uncontrolled hypertension or uncontrolled diabetes, in the opinion of the Investigator (NOTE: controlled hypertension and/or controlled diabetes are not exclusionary)
• •11. Presence of cancer not in remission for at least 5 years prior to the Screening Visit (excludes non-melanomatous skin cancer)
• •12. Hospitalized for psychiatric disorder in the previous 12 months or has a history of attempted suicide within 5 years prior to the Screening Visit
• •13. Unable to abstain from protocol-defined prohibited medications during the study
• •14. Clinical laboratory tests (after ≥4 hours fasting) at the Screening Visit that show results outside the normal ranges for the following clinical laboratory tests that, in the Investigator's opinion, are judged to be clinically significant:
• •* hemoglobin
• •* hematocrit
• •* total white blood cell count (WBC)
• •* platelet count
• •* serum glucose
• •* serum potassium
• •* ALT
• •* AST
• •* alkaline phosphatase
• •* serum creatinine
• •15. Clinical laboratory tests at the Screening Visit that show any of the following:
• •* positive serum hCG (female subjects only)
• •* positive urine drug screen (exception is evidence of authorized prescribed medications)
• •* positive urine cotinine test
• •16. Presence of any uncontrolled (in the Investigator's medical opinion) systemic disease, including, but not limited to renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or psychiatric disease
• •17. Electrocardiogram obtained at Screening Visit that shows (in the Investigator's medical opinion) medically significant abnormalities (e.g., left bundle branch block, frequent premature ventricular contractions, chronic atrial fibrillation, or QTcB interval prolongation \> 450 msec for males and \> 470 msec for females)
• •18. Presence of current drug or alcohol abuse, in the Investigator's opinion, making it unlikely that the requirements of the subject's participation in the protocol will be met
• •19. History of allergic reaction (known hypersensitivity) to albuterol sulfate and/or lactose, in any formulation
• •20. History of intolerance to aerosolized β2-adrenergic agonists
• •21. Receipt of a drug or biologic in an investigational research study within the 30 days prior to the Screening Visit
• •22. An elective surgical or medical procedure currently is planned or scheduled to be performed during the study (this excludes routine immunotherapy/desensitization procedures that are being performed on a regular schedule and have been unchanged for at least 3 months prior to the Screening Visit)
• •23. Presence of a clinically diagnosed upper respiratory tract infection within the 7 days prior to the Screening Visit
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