Beclomethasone Dipropionate HFA in Adult and Adolescent Subjects With Mild to Moderate Persistent Asthma

Exclusion Criteria

• •1. Incidence of asthma exacerbations per NAEPP ERP-3(1) (Appendix IV) within the last 3 months.
• •2. Respiratory diseases other than asthma or allergic rhinitis.
• •3. Uncontrolled asthma defined as having 3 - 4 of the following symptoms: a) Daytime asthma symptoms (\> twice/week) b) Night waking due to asthma c) Reliever needed for symptoms more than twice a week (excluding reliever taken before exercise) d) Any activity limitation due to asthma per GINA, Chapter 2, Box 2-2, page 29.
• •4. Life threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnia; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s) within the previous 10 years.
• •5. The known presence or history of tuberculosis infection of the respiratory tract; untreated systemic fungal, bacterial, parasitic or viral infections; or ocular herpes simplex.
• •6. The presence or history of a clinically significant medical condition, other than asthma including laboratory result abnormalities that in the opinion of the investigator would put the subject at risk through study participation or would affect the study analyses if the disease exacerbated during the study. Following conditions should be considered carefully: congestive heart failure, recent myocardial infraction, uncontrolled hypertension, cardiac arrhythmias and diabetes mellitus, epilepsy, glaucoma, cataract, uncontrolled hypothyroidism, liver failure, severe osteoporosis, peptic ulceration and renal impairment.
• •7. Hospitalization for asthma or a respiratory condition in the last 12 months.
• •8. Need for oral steroids and/or antibiotics for lung disease in last 3 months.
• •9. Current or recent respiratory infection or current oral candida infection.
• •10. Participation in another clinical trial or study within 1 month or at least 5 half-lives (whichever is longer) preceding the first dose of trial medication. Previous participation in this study.
• •11. Use of any of the following excluded respiratory medications within the indicated time frame prior to screening and throughout the study:
• •1. Anti-IgE antibody (e.g. Xolair) and depot corticosteroids 3 months
• •2. Systemic (I.V., I.M., oral) corticosteroids 3 months
• •3. Inhaled corticosteroids Stop at screening
• •4. Long-acting anti-muscarinics (e.g., tiotropium) 48 hours
• •5. Short-acting anti-muscarinics (e.g., ipratropium) 24 hours
• •6. LABA (e.g., salmeterol, formoterol,etc.) 12 hours
• •7. Short-acting β2-adrenergic agonists (SABA), except for study rescue medication (albuterol) 6 hours
• •8. Oral β2-adrenergic agonists 1 month
• •9. Topical dermatologic corticosteroids of intermediate to high potency such as fluticasone propionate, mometasone furoate 14 days
• •10. Oral or nasal antihistamines unless on a stable dose for 30 days prior screening.
• •11. Immunologically active biologic medications such as anti-TNFα (tumor necrosis factor) 3 months
• •12. Immunosuppressive therapy such as methotrexate, gold, Azathioprine 1 month
• •13. Immunotherapy initiation within 3 months or change in dose within 1 month
• •14. Over-the-counter bronchodilators 2 weeks
• •15. Marijuana 1 month
• •16. Inhaled nicotine such as e-cigarettes 1 day
• •12. Use of the following medications 30 days before screening:
• •1. Non-cardio selective β-blockers (e.g. propranolol, nadolol, carvedilol, labetalol, sotalol)
• •2. Digitalis
• •3. Thiazide diuretics
• •4. Oral decongestants
• •5. Cytochrome P450 3A4 enzyme inhibitors
• •6. Benzodiazepines
• •7. Cyclic antidepressants
• •8. Monoamine oxidase inhibitors
• •9. Diazoxide
• •10. Ketoconazole, itraconazole
• •11. Phenytoin
• •12. Rifampicin
• •13. Mifepristone
• •13. Known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation.
• •14. Evidence (as assessed by the Investigator using good clinical judgment) of alcohol or drug abuse or dependency at the time of screening, for the 6 months prior to screening.
• •15. Live in the same household as currently enrolled subject.
• •16. Any other reason which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.