Indacaterol EfectIveness In COPD Patients With Tuberculosis History
Condition: Patients With Moderate-to-severe COPD With Destroyed Lung by Tuberculosis
MeSH terms: Tuberculosis
Intervention: Indacaterol; Control
Intervention description: Indacaterol 150µg once daily oral inhalation; Placebo once daily oral inhalation
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 136.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This clinical study will assess efficacy and safety of indacaterol (150㎍ o.d.) in patients
      with Chronic Obstructive Pulmonary Disease (COPD) with destroyed lung by tuberculosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female adults aged ≥ 19 years in international age

          -  Patients with a diagnosis of moderate-to-severe COPD as classified by the GOLD
             guidelines (2009)

          -  Patients with at least one finding of destructed pulmonary parenchyma in the chest
             X-ray and the sum of all legion volumes equivalent to over 1/3 of one lung

          -  Patients with a history of tuberculosis and no change in the chest imaging test over
             the past one year

          -  Patients who can voluntarily sign an Informed Consent Form prior to initiation of any
             study-related procedure

        Exclusion Criteria:

          -  Pregnant or nursing (lactating) women

          -  Women of childbearing potential not willing to use effective contraception. However,
             those who have a negative pregnancy test and agree to use effective contraception can
             participate. Effective contraception does not include periodical abstinence (e.g.
             basal body temperature, menstrual cycle contraceptive method, etc) but means use of
             contraception which must include one of barrier contraceptive methods.

             e.g.) condom (barrier contraceptive method), diaphragms (barrier contraceptive
             method), oral contraceptives, intrauterine device, Depo injection, etc.

          -  Patients who have been admitted to hospital for COPD worsening within 6 weeks prior to
             visit 1

          -  Patients with a history of respiratory infection within 6 weeks prior to visit 1

          -  Patients requiring long-term oxygen therapy (>15 hours/1 day) for chronic hypoxemia
             (it is allowed to use up to a total of 10 out of 24 hours on a PRN basis)

          -  Patients with a history of asthma

          -  Unstable ischaemic heart disease, arrhythmia (except for stable ventricular
             fibrillation) and uncontrolled hypertension

          -  Patients with a history of long QT syndrome or whose QTc interval measured at Visit 2
             is prolonged: >450 ms (males) or >470 ms (females)

          -  Uncontrolled hypothyroidism and hyperthyroidism

          -  Hypokalemia: plasma potassium level < 3.0 mEq/L

          -  Patients with creatinine level ≥2 the upper limit of normal

          -  Patients with AST/ALT level ≥2 the upper limit of normal

          -  Patients with lung cancer or a history of lung cancer

          -  Patients with active cancer or a history of cancer with less than 5 years disease-free
             survival (whether or not there is evidence of local recurrence or metastases;
             localized basal cell carcinoma of the skin without metastases is acceptable).

          -  Patients with a history of hypersensitivity to any of the study drugs or to drugs with
             similar chemical structures including untoward reactions to sympathomimetic amines or
             inhaled medication or any component thereof.

          -  Patients who have had live attenuated vaccinations within 30 days prior to Visit 1

          -  Patients who have had treatment with investigational drugs, within 30 days or 5
             half-lives prior to Visit 1, whichever is longer.

          -  Patients unable to successfully use a dry powder inhaler device, metered dose inhaler
             or perform spirometry measurements

          -  Other cases which are considered ineligible for this clinical study by the principal
             investigator and subinvestigator