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Indacaterol EfectIveness In COPD Patients With Tuberculosis History (INFINITY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01778062
First received: January 25, 2013
Last updated: October 1, 2015
Last verified: October 2015
  Purpose
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.

Condition Intervention Phase
Patients With Moderate-to-severe COPD With Destroyed Lung by Tuberculosis
Drug: Indacaterol
Drug: Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Trough Forced Expiratory Volume in One Second Change [ Time Frame: 8 week ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • St. George Respiratory Questionnaire for COPD (SGRQ-C) Change After 8 Weeks of Treatment [ Time Frame: 8 week ] [ Designated as safety issue: No ]
    The SGRQ-C contains 14 questions divided into two components. Part 1 produces "Symptoms" scores and Part 2 "Activity" and "Impacts" scores. 14 questions which are divided in three domains: "symptom" (question 1-7), "activity" (question 9, 12) and "impact" (question 8, 10, 11, 13 and 14). The total score is 0 to 100 with a higher score indicating greater impairment of health status. Mixed model used baseline SGRQ, FEV1 prior to and 10-15 minutes post inhalation of salbutamol/albuterol, FEV1 prior to and 1 hour post inhalation of ipratropium, and inhaled corticosteroid use at baseline as covariates.

  • Change From Baseline in Transition Dyspnea Index (TDI) After 8 Weeks of Treatment [ Time Frame: 8 week ] [ Designated as safety issue: No ]
    TDI focal score is based on three domains: functional impairment, magnitude of task and magnitude of effort. Each domain is scored from -3 (major deterioration) to 3 (major improvement) to give an overall TDI focal score of -9 to 9 with a negative score indicating a deterioration from baseline. A 1 unit difference in the TDI focal score is clinically significant. Mixed model used baseline dyspnoea index, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to 1 hour post inhalation of ipratropium as covariates.

  • Incidence of COPD Exacerbation [ Time Frame: 8 week ] [ Designated as safety issue: No ]
    Number of COPD exacerbation during 8-week treatment. COPD exacerbations are defined as a new onset or worsening of at least one respiratory symptom (i.e. dyspnea, cough, sputum purulence or volume, or wheeze) present for at least 3 consecutive days, documented change or increase in COPD-related treatment due to worsening symptoms or documented COPD-related hospitalizations or emergency room visits.


Enrollment: 136
Study Start Date: February 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Indacaterol
Indacaterol 150 µg once daily
Drug: Indacaterol
Indacaterol 150µg once daily oral inhalation
Placebo Comparator: Placebo
Placebo once daily
Drug: Control
Placebo once daily oral inhalation
Other Name: Placebo

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

Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778062

Locations
Korea, Republic of
Novartis Investigative Site
Anyang-si, Gyeonggi-do, Korea, Republic of, 431-070
Novartis Investigative Site
Koyang-si, Gyeonggi-do, Korea, Republic of, 410-773
Novartis Investigative Site
Jeonju-si, Jeollabuk-do, Korea, Republic of, 561-712
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 03722
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 05505
Novartis Investigative Site
Seoul, Korea, Korea, Republic of, 110 744
Novartis Investigative Site
Koyang, Kyunggi, Korea, Republic of, 410-719
Novartis Investigative Site
Incheon, Korea, Republic of, 405-760
Novartis Investigative Site
Seoul, Korea, Republic of, 110-102
Novartis Investigative Site
Seoul, Korea, Republic of, 130-872
Novartis Investigative Site
Seoul, Korea, Republic of, 143-729
Novartis Investigative Site
Seoul, Korea, Republic of, 150-713
Novartis Investigative Site
Seoul, Korea, Republic of, 152-703
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Principal Investigator: Chul-Gyu Yoo, MD PhD Seoul National University Hospital
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01778062     History of Changes
Other Study ID Numbers: CQAB149BKR01 
Study First Received: January 25, 2013
Results First Received: August 18, 2015
Last Updated: October 1, 2015
Health Authority: Korean FDA: Korea (south)

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on September 26, 2016