SAPSAdvair, Montelukast, Theophylline, and Ipratropium Treatment for Smoking Asthmatics

Study start date: October 1, 2012

Inclusion Criteria: Gender and Age: Males and females, ages 18- 50 Current Smoker: Smoke at least 5 cigarettes per day for at least 5 years Positive urine cotinine test Asthma: Physician diagnosed asthma Symptomatic, as evidenced by Use of SABA two or more times per week for relief of asthma symptoms, or One or more nocturnal awakenings per week for asthma symptoms ACRC - SC MEETING - 19 MAY 2012 SAPS │ 25 Confidential, not for attribution or citation. Pre-BD FEV1 greater than or equal to 40% predicted Asthma diagnosis confirmed by either albuterol reversibility of FEV1 by 12% or more, or 20% fall in FEV1 at 8mg or less of methacholine If over age 45, a DLco greater than 80% predicted Females of childbearing potential: not pregnant, not lactating and agree to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal) for the duration of the study. Exclusion Criteria: Diagnosis of COPD or emphysema Other major chronic illnesses in the opinion of the investigator that might interfere with the study: - e.g. including but not limited to uncontrolled diabetes, uncontrolled HIV infection or other immune system disorder, hyperthyroidism, seizure disorders, renal failure, liver disease, non-skin cancer, unstable psychiatric illness. Recent active substance abuse (in past 6 months) Lung disease other than asthma including COPD, bronchiectasis, sarcoidosis, or other significant lung disease Unstable cardiac disease (decompensated CHF, unstable angina, recent MI, atrial fibrillation, supraventricular or ventricular tachycardia, congenital heart disease, or severe uncontrolled hypertension). High risk of near fatal or fatal asthma as defined by the following 1-3 ICU admission of asthma in the past year more than 2 hospitalizations for asthma in the previous year more than 3 ED visits for asthma in the previous year intubation or ICU admission for asthma in the past 2 years use of more than 2 canisters of inhaled short-acting beta2-agonist in past month Acute asthma exacerbation in the past 4 weeks (treatment with systemic corticosteroids)