Indacaterol EfectIveness In COPD Patients With Tuberculosis History

NCT01778062 | Completed Phase 3 Results

• 1 other identifier: CQAB149BKR01
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 13

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Trough Forced Expiratory Volume in One Second Change

  Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariate

  8 week

Secondary Outcomes (3)

• St. George Respiratory Questionnaire for COPD (SGRQ-C) Change After 8 Weeks of Treatment

  8 week

• Change From Baseline in Transition Dyspnea Index (TDI) After 8 Weeks of Treatment

  8 week

• Incidence of COPD Exacerbation

  8 week

Study Arms (2)

Indacaterol

EXPERIMENTAL

Indacaterol 150 µg once daily

Drug: Indacaterol

Placebo

PLACEBO COMPARATOR

Placebo once daily

Drug: Control

Interventions

Indacaterol DRUG

Indacaterol 150µg once daily oral inhalation

Indacaterol

Control DRUG

Placebo once daily oral inhalation

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (13)

Novartis Investigative Site

Anyang-si, Gyeonggi-do, 431-070, South Korea

Location

Novartis Investigative Site

Koyang-si, Gyeonggi-do, 410-773, South Korea

Location

Novartis Investigative Site

Jeonju, Jeollabuk-do, 561-712, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 03722, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 05505, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 110 744, South Korea

Location

Novartis Investigative Site

Koyang, Kyunggi, 410-719, South Korea

Location

Novartis Investigative Site

Seoul, Seoul, 150-713, South Korea

Location

Novartis Investigative Site

Incheon, 405-760, South Korea

Location

Novartis Investigative Site

Seoul, 110-102, South Korea

Location

Novartis Investigative Site

Seoul, 130-872, South Korea

Location

Novartis Investigative Site

Seoul, 143-729, South Korea

Location

Novartis Investigative Site

Seoul, 152-703, South Korea

Location

MeSH Terms

Interventions

indacaterol

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Chul-Gyu Yoo, MD PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: January 29, 2013
• Study Start: February 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 23, 2015
• Results First Posted: September 18, 2015

Record last verified: 2015-10

Locations

KR (13)