Clinical trial NCT01778062: Indacaterol EfectIveness In COPD Patients With Tuberculosis History
Official title: A Phase Ⅲb, Multicenter, Double-blind, Randomized, Controlled Trial, to Assess the Efficacy and Safety of Indacaterol (150㎍ o.d.) vs. Placebo, in Patients With Moderate-to-severe COPD With Destroyed Lung by Tuberculosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Patients With Moderate-to-severe COPD With Destroyed Lung by Tuberculosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-01-29
Enrollment: 136
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Trough Forced Expiratory Volume in One Second Change
timeFrame: 8 week
Secondary outcomes:
measure: St. George Respiratory Questionnaire for COPD (SGRQ-C) Change After 8 Weeks of Treatment
timeFrame: 8 week
measure: Change From Baseline in Transition Dyspnea Index (TDI) After 8 Weeks of Treatment
timeFrame: 8 week
measure: Incidence of COPD Exacerbation
timeFrame: 8 week
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Koyang-si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Jeonju-si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Jeollabuk-do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Koyang
country: Korea, Republic of
facility: Novartis Investigative Site
state: Kyunggi
city: Incheon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
Study officials:
affiliation: Seoul National University Hospital
name: Chul-Gyu Yoo, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: