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This study is designed to collect long term safety data of indacaterol (300 µg o.d.) in Japanese patients with moderate to severe COPD. Data from this study will be used for the registration of indacaterol in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indacaterol 300 µg | Experimental | Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study. |
|
| Salmeterol 50 µg | Active Comparator | Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indacaterol 300 µg | Drug | Indacaterol 300 µg once daily (od) via SDDPI |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment | The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment. Low Pulse Rate was defined as a pulse rate <40 bpm or <= to 50 bpm and a decrease from baseline >= to 15 bpm. High Pulse Rate was defined as a pulse rate >130 bpm or >= to 120 bpm and an increase from baseline >= to 15 bpm. | 52 weeks |
| The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment | The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: <75 mmHg or <= to 90 mmHg and a decrease from baseline >= to 20 mmHg. A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: >200 mmHg or >= to 180 mmHg and an increase from baseline >= to 20 mmHg. | 52 weeks |
| The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment | The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic blood pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: <40 mmHg or <= to 50 mmHg and a decrease from baseline >= to 15 mmHg. A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: >115 mmHg or >= to 105 mmHg and an increase from baseline >= to 15 mmHg. | 52 weeks |
| The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment | The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline. The QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms). Notable QTc interval >450 ms for males and >470 ms for females. The maximum QTc increase from baseline at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and >60 ms. |
| Measure | Description | Time Frame |
|---|---|---|
| Trough Forced Expiratory Volume in 1 Second (FEV1) After 12, 24 and 52 Weeks | Trough FEV1 was defined as the mean of the values at 23 h 10 min and 23 h 45 min after dosing at clinic on the previous day. Trough FEV1 was analyzed after 12, 24 and 52 weeks using a mixed model which contained the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 30 minutes post inhalation of salbutamol as covariates. |
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Inclusion Criteria:
1. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines) and:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator Site | Asahikawa | Japan | ||||
| Novartis Investigator Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Indacaterol 300 μg | Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study. |
| FG001 | Salmeterol 50 μg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Salmeterol 50 µg |
| Drug |
Salmeterol 50 µg twice daily (bid) via Diskus® |
|
| 52 weeks |
| Serum Potassium (mmol/L) at Weeks 4, 8, 12, 24, 36, 44, and 52 | The least squares mean of the serum potassium in mmol/L at weeks 4, 8, 12, 24, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate. | 4, 8, 12, 24, 36, 44, and 52 weeks |
| Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 4, 8, 12, 24, 36, 44, and 52 | The least squares mean of the blood glucose in mmol/L at weeks 4, 8, 12, 24, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate. | 4, 8, 12, 24, 36, 44, and 52 weeks |
| After 12, 24 and 52 weeks |
| Bunkyō City |
| Japan |
| Novartis Investigator Site | Gifu | Japan |
| Novartis Investigator Site | Hamamatsu | Japan |
| Novartis Investigator Site | Himeji | Japan |
| Novartis Investigator Site | Hiroshima | Japan |
| Novartis Investigator Site | Iwata | Japan |
| Novartis Investigator Site | Kanazawa | Japan |
| Novartis Investigator Site | Kasaoka | Japan |
| Novartis Investigator Site | Kawasaki | Japan |
| Novartis Investigator Site | Kishiwada | Japan |
| Novartis Investigator Site | Kitakyushu | Japan |
| Novartis Investigator Site | Kochi | Japan |
| Novartis Investigator Site | Koga | Japan |
| Novartis Investigator Site | Kurume | Japan |
| Novartis Investigator Site | Kyoto | Japan |
| Novartis Investigator Site | Maebashi | Japan |
| Novartis Investigator Site | Matsusaka | Japan |
| Novartis Investigator Site | Morioka | Japan |
| Novartis Investigator Site | Nagaoka | Japan |
| Novartis Investigator Site | Nagoya | Japan |
| Novartis Investigator Site | Naka-gun | Japan |
| Novartis Investigator Site | Noda | Japan |
| Novartis Investigator Site | Obihiro | Japan |
| Novartis Investigator Site | Sakai | Japan |
| Novartis Investigator site | Sapporo | Japan |
| Novartis Investigator Site | Sendai | Japan |
| Novartis Investigator Site | Setagaya-ku | Japan |
| Novartis Investigator Site | Sumida-ku | Japan |
| Novartis Investigator Site | Tenri | Japan |
| Novartis Investigator Site | Tokyo | Japan |
| Novartis Investigator Site | Ube | Japan |
| Novartis Investigator Site | Wakayama | Japan |
| Novartis Investigator Site | Yabu | Japan |
| Novartis Investigator Site | Yanagawa | Japan |
| Novartis Investigator Site | Yokkaichi | Japan |
| Novartis Investigator Site | Yokohama | Japan |
Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study. |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Indacaterol 300 μg | Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study. |
| BG001 | Salmeterol 50 μg | Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment | The number of participants with newly occurring or worsening clinically notable vital sign: Pulse Rate in beats per minute (bpm) at anytime post baseline (BL) by treatment. Low Pulse Rate was defined as a pulse rate <40 bpm or <= to 50 bpm and a decrease from baseline >= to 15 bpm. High Pulse Rate was defined as a pulse rate >130 bpm or >= to 120 bpm and an increase from baseline >= to 15 bpm. | The safety population included all patients who received at least one dose of study drug. | Posted | Number | Participants | 52 weeks |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment | The number of participants with newly occurring or worsening clinically notable vital sign: Systolic Blood Pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Systolic Blood Pressure was defined as a systolic blood pressure measurement: <75 mmHg or <= to 90 mmHg and a decrease from baseline >= to 20 mmHg. A High Systolic Blood Pressure was defined as a systolic blood pressure measurement: >200 mmHg or >= to 180 mmHg and an increase from baseline >= to 20 mmHg. | The safety population included all patients who received at least one dose of study drug. | Posted | Number | Participants | 52 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Primary | The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment | The number of participants with newly occurring or worsening clinically notable vital sign: Diastolic blood pressure (mmHg) at anytime post baseline (BL) by treatment. A Low Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: <40 mmHg or <= to 50 mmHg and a decrease from baseline >= to 15 mmHg. A High Diastolic Blood Pressure was defined as a diastolic blood pressure measurement: >115 mmHg or >= to 105 mmHg and an increase from baseline >= to 15 mmHg. | The safety population included all patients who received at least one dose of study drug. | Posted | Number | Participants | 52 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Primary | The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment | The number of participants with newly occurring or worsening clinically notable QTc Interval value at anytime post baseline. The QTc interval is calculated using Fridericia's formula: QTc= QT/cube root RR. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves in milliseconds (ms). Notable QTc interval >450 ms for males and >470 ms for females. The maximum QTc increase from baseline at any time during the study was also tabulated with absolute and relative frequencies for categories 30- 60 ms and >60 ms. | The safety population included all patients who received at least one dose of study drug. | Posted | Number | Participants | 52 weeks |
| ||||||||||||||||||||||||||||||||||||||
| Primary | Serum Potassium (mmol/L) at Weeks 4, 8, 12, 24, 36, 44, and 52 | The least squares mean of the serum potassium in mmol/L at weeks 4, 8, 12, 24, 36, 44 and 52. Mixed model used baseline serum potassium as a covariate. | The safety population included all patients who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | mmol/L | 4, 8, 12, 24, 36, 44, and 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 4, 8, 12, 24, 36, 44, and 52 | The least squares mean of the blood glucose in mmol/L at weeks 4, 8, 12, 24, 36, 44 and 52. Mixed model used baseline blood glucose as a covariate. | The safety population included all patients who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | mmol/L | 4, 8, 12, 24, 36, 44, and 52 weeks |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Trough Forced Expiratory Volume in 1 Second (FEV1) After 12, 24 and 52 Weeks | Trough FEV1 was defined as the mean of the values at 23 h 10 min and 23 h 45 min after dosing at clinic on the previous day. Trough FEV1 was analyzed after 12, 24 and 52 weeks using a mixed model which contained the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 30 minutes post inhalation of salbutamol as covariates. | The intention-to-treat (ITT) population included all randomized patients who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | Liters | After 12, 24 and 52 weeks |
|
|
52 weeks
Safety population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Indacaterol 300 μg | Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study. | 16 | 125 | 61 | 125 | ||
| EG001 | Salmeterol 50 μg | Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study. | 4 | 61 | 26 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA | Systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Computerised tomogram abnormal | Investigations | MedDRA | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Arteriosclerosis obliterans | Vascular disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C510790 | indacaterol |
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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| Male |
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| Units |
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| Counts |
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| Participants |
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| Units |
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| Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Participants |
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