Patients With Moderate-to-severe COPD With Destroyed Lung by TuberculosisPhase 3INFINITYNCT01778062
Indacaterol EfectIveness In COPD Patients With Tuberculosis History
A Phase 3 study testing Indacaterol in people with Patients With Moderate-to-severe COPD With Destroyed Lung by Tuberculosis, run by Novartis Pharmaceuticals at 13 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Patients With Moderate-to-severe COPD With Destroyed Lung by Tuberculosis
- What is being tested?
- Indacaterol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 13 sitesSouth Korea
- Study dates
- Feb 2013to Sep 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
South Korea13 sites
Novartis Investigative Site
Anyang-si, Gyeonggi-do, 431-070
Novartis Investigative Site
Incheon, 405-760
Novartis Investigative Site
Jeonju, Jeollabuk-do, 561-712
Novartis Investigative Site
Koyang, Kyunggi, 410-719
Novartis Investigative Site
Koyang-si, Gyeonggi-do, 410-773
Novartis Investigative Site
Seoul, Korea, 03722
Novartis Investigative Site
Seoul, Korea, 05505
Novartis Investigative Site
Seoul, Korea, 110 744
Novartis Investigative Site
Seoul, Seoul, 150-713
Novartis Investigative Site
Seoul, 110-102
Novartis Investigative Site
Seoul, 130-872
Novartis Investigative Site
Seoul, 143-729
Novartis Investigative Site
Seoul, 152-703
About this study
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
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.
Read the 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.
- Being tested
- Indacaterol, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IndacaterolDrug
Indacaterol 150µg once daily oral inhalation
ControlDrug
Also called Placebo
Placebo once daily oral inhalation
| Study group | Role | What they receive |
|---|---|---|
| Indacaterol | Experimental | Indacaterol 150 µg once daily Receives: Drug: Indacaterol |
| Placebo | Placebo comparator | Placebo once daily Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 week
Secondary outcomes (3)
St. George Respiratory Questionnaire for COPD (SGRQ-C) Change After 8 Weeks of Treatment
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.
Measured: 8 week
Change From Baseline in Transition Dyspnea Index (TDI) After 8 Weeks of Treatment
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.
Measured: 8 week
Incidence of COPD Exacerbation
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.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Patients With Moderate-to-severe COPD With Destroyed Lung by TuberculosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chul-Gyu Yoo, MD PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778062
- Sponsor's protocol ID
- CQAB149BKR01
- Acronym
- INFINITY
- Status last verified
- Oct 2015
- First submitted
- 25 Jan 2013
- Last updated
- 23 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01778062
- Acronym / sponsor ID
- INFINITY / CQAB149BKR01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 29 Jan 2013 (estimated)
- Results
- Posted 18 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indacaterol | Experimental | Drug: IndacaterolIndacaterol 150 µg once daily |
| Placebo | Placebo comparator | Drug: ControlPlacebo once daily |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IndacaterolIndacaterol 150µg once daily oral inhalation | Drug | Indacaterol |
| ControlAlso: PlaceboPlacebo once daily oral inhalation | Drug | Placebo |
Primary outcome
Trough Forced Expiratory Volume in One Second Change
Time frame: 8 week
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
3 secondary outcomes
St. George Respiratory Questionnaire for COPD (SGRQ-C) Change After 8 Weeks of Treatment
Time frame: 8 week
Change From Baseline in Transition Dyspnea Index (TDI) After 8 Weeks of Treatment
Time frame: 8 week
Incidence of COPD Exacerbation
Time frame: 8 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chul-Gyu Yoo, MD PhD principal investigator
Seoul National University Hospital
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Indacaterol in people with Patients With Moderate-to-severe COPD With Destroyed Lung by Tuberculosis, run by Novartis Pharmaceuticals at 13 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trough Forced Expiratory Volume in One Second Change (time frame: 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2015.