A Pilot Study to Determine the Feasibility and Utility of Implementing of the Full Scale TOM Trial
Condition: Asthma
MeSH terms: Asthma
Intervention: Fluticasone 250 mg/salmeterol 50 mg; Montelukast 10mg; Theophylline 400 mg; ipratropium
Intervention description: Drug: Fluticasone 250 mg/salmeterol 50 mg Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo; Participants will be assigned to montelukast once a day for 24 weeks.; Participants will be assigned to theophylline once a day for 24 weeks; Participants will be assigned to ipratropium 2.5 mL of 0.02% solution via mini nebulizer 3 times a day day for 24 weeks.
Intervention MeSH terms: Fluticasone; Xhance; Theophylline; Salmeterol Xinafoate; Ipratropium; Fluticasone-Salmeterol Drug Combination; Montelukast
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: asthma,smokers

Summary:

      The primary aim of the pilot (SAPS) protocol is to determine the feasibility and utility of
      implementing the provisional design of the full scale TOM trial (e.g., the six month
      treatment period, the impact of the smoking cessation intervention).

      There is no active hypothesis for the Vanguard Protocol.
    

Eligibility criteria:

        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)