Indacaterol EfectIveness In COPD Patients With Tuberculosis History

NCT ID: NCT01778062

Last Updated: 2015-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-09-30

Brief 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.

Detailed Description

There are few clinical studies in patients with COPD with destroyed lung by tuberculosis because tuberculosis patients are usually excluded from (phase II or III) clinical trials for drug registration although they are not prohibited from prescription of COPD drugs.

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

Conditions

Patients With Moderate-to-severe COPD With Destroyed Lung by Tuberculosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Indacaterol

Indacaterol 150 µg once daily

Group Type: EXPERIMENTAL

Indacaterol

Intervention Type: DRUG

Indacaterol 150µg once daily oral inhalation

Placebo

Placebo once daily

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: DRUG

Placebo once daily oral inhalation

Interventions

Indacaterol

Indacaterol 150µg once daily oral inhalation

Intervention Type: DRUG

Control

Placebo once daily oral inhalation

Intervention Type: DRUG

Other Intervention Names

Placebo

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chul-Gyu Yoo, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Novartis Investigative Site

Anyang-si, Gyeonggi-do, South Korea

Novartis Investigative Site

Koyang-si, Gyeonggi-do, South Korea

Novartis Investigative Site

Jeonju, Jeollabuk-do, South Korea

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Koyang, Kyunggi, South Korea

Novartis Investigative Site

Seoul, Seoul, South Korea

Novartis Investigative Site

Incheon, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CQAB149BKR01

Identifier Type: -

Identifier Source: org_study_id