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This is a 52-week treatment, multi-center, randomized, open label, parallel group study to assess the long term safety and tolerability of once-daily QVA149 (indacaterol and NVA237 ([glycopyrronium bromide]) using tiotropium as an active control in Japanese patients with moderate to severe chronic obstructive pulmonary disease (COPD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QVA149 | Experimental | QVA149 110/50 μg once a day (o.d) |
|
| Tiotropium | Active Comparator | tiotropium 18 μg o.d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QVA149 | Drug | QVA149 (110 μg indacaterol / 50 μg glycopyrronium o.d.), delivered via Concept1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Death | An AE was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event was not considered to be related to study drug. Study drug includes the investigational drug under evaluation and the comparator drug or placebo that was given during any phase of the study. Adverse events starting on or after the time of the first inhalation of study drug were classified as a treatment emergent adverse event. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period | Clinically notable hematology values were: hemoglobin - male <11.5g/dL, female <9.5 g/dL; hematocrit - male <37%, female <32%; white cell count - <2800µL or >16000µL; platelets - <7.5 10*4/µL or >70.0 10*4/µL | 52 weeks |
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Inclusion Criteria:
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 Investigative Site | Anjo | Aichi-ken | 446-8602 | Japan | ||
| Novartis Investigative Site |
There was a pre-screening visit where informed consent was obtained and current COPD medications reviewed and in suitable patients, if necessary, arrangements were made to adjust prohibited COPD therapy to allowable COPD therapy. The interval between Visit 2 and 3 was a 7-days run-in period used to assess eligibility and to collect baseline values.
121 patients were randomized to the QVA149 group; however, demographics was on safety set and excluded 2 patients who did not take study drug
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| ID | Title | Description |
|---|---|---|
| FG000 | QVA149 | QVA149 110/50 μg o.d. (once a day) |
| FG001 | Tiotropium | tiotropium 18 μg o.d. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Tiotropium |
| Drug |
Tiotropium (18 μg o.d.), delivered via Handihaler® |
|
| Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period | Clinically notable biochemistry values were: total protein - <4.0 g/dL or >9.5 g/dL; albumin <2.5 g/dL; bilirubin (total) >1.9 mg/dL; BUN >27 mg/dL; creatinine >1.99 mg/dL; AST >3 x ULN U/L; ALT >3 x ULN U/L; ALP >3 x ULN U/L; y-GTP >3 x ULN U/L; sodium <125 mEq/L or >160 mEq/L; potassium <3.0 mEq/L or >6.0 mEq/L; glucose <51.0 mg/dL or >180.0 mg/dL | 52 weeks |
| Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period | Clinically notable vital sign values were: pulse rate - low, <40 bpm or <=50 bpm and decrease from baseline >=15bpm; pulse rate high, >130 bpm or >=120bpm and increase from baseline >=15 bpm. Systolic blood pressure - low, <75 mmHg or <=90 mmHg and decrease from baseline >=20 mmHg; high, >200 mmHg or >=180 mmHg and increase from baseline >=20 mmHg. Diastolic blood pressure - low, <40 mmHg or <=50 mmHg and decrease from baseline >=15 mmHg; high, >115 mmHg or >=105 mmHg and increase from baseline >=15 mmHg. | 52 weeks |
| Number of Patients With Newly Occurring or Worsening Clinically Notable Fridericia's QTc Values at Any Time-point Over the Whole Treatment Period | Clinically notable change from baseline was an increase from baseline of 30 or greater milliseconds (ms). | 52 weeks |
| Change in Pre-dose Forced Expiratory Volume in One Second (FEV1) From Baseline | Pre-dose FEV1 is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FEV1 value on Day 1 (Week 1). | Weeks 3, 6, 12, 24, 36, 52 |
| Change in Pre-dose Forced Vital Capacity (FVC) From Baseline | Pre-dose FVC is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FVC value on Day 1 (Week 1). | Weeks 3, 6, 12, 24, 36, 52 |
| Nagoya |
| Aichi-ken |
| 457-8511 |
| Japan |
| Novartis Investigative Site | Nishio | Aichi-ken | 445-8510 | Japan |
| Novartis Investigative Site | Akita | Akita | 010-0933 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 811-0213 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 812-0033 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 815-8588 | Japan |
| Novartis Investigative Site | Kasuga | Fukuoka | 816-0813 | Japan |
| Novartis Investigative Site | Kitakyushu | Fukuoka | 820-0052 | Japan |
| Novartis Investigative Site | Kurume | Fukuoka | 830-0011 | Japan |
| Novartis Investigative Site | Yanagawa | Fukuoka | 832-0059 | Japan |
| Novartis Investigative Site | Asahikawa | Hokkaido | 070-8644 | Japan |
| Novartis Investigative Site | Obihiro | Hokkaido | 080-0805 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 060-8648 | Japan |
| Novartis Investigative Site | Himeji | Hyōgo | 672-8064 | Japan |
| Novartis Investigative Site | Kanazawa | Ishikawa-ken | 920-8610 | Japan |
| Novartis Investigative Site | Takamatsu | Kagawa-ken | 760-8538 | Japan |
| Novartis Investigative Site | Kawasaki | Kanagawa | 210-0852 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 236-0051 | Japan |
| Novartis Investigative Site | Kochi | Kochi | 780-8077 | Japan |
| Novartis Investigative Site | Kōshi | Kumamoto | 861-1196 | Japan |
| Novartis Investigative Site | Matsusaka | Mie-ken | 515-8544 | Japan |
| Novartis Investigative Site | Ueda | Nagano | 386-8610 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 545-8586 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 558-8558 | Japan |
| Novartis Investigative Site | Sayama | Osaka | 589-0022 | Japan |
| Novartis Investigative Site | Takatsuki | Osaka | 569-1192 | Japan |
| Novartis Investigative Site | Toyonaka | Osaka | 560-8552 | Japan |
| Novartis Investigative Site | Kawaguhi-city | Saitama | 333-0833 | Japan |
| Novartis Investigative Site | Hamamatsu | Shizuoka | 430-8525 | Japan |
| Novartis Investigative Site | Fuchū | Tokyo | 183-8524 | Japan |
| Novartis Investigative Site | Meguro City | Tokyo | 152-8902 | Japan |
| Novartis Investigative Site | Wakayama | Wakayama | 641-8510 | Japan |
| Novartis Investigative Site | Yamagata | Yamagata | 990-8533 | Japan |
| Novartis Investigative Site | Ube | Yamaguchi | 755-0241 | Japan |
| Safety Set (for Demographics) |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | QVA149 | QVA149 110/50 μg once a day (o.d) |
| BG001 | Tiotropium | tiotropium 18 μg o.d. |
| 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 |
| ||||||||||||||||
| Baseline Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Baseline Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Baseline Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| 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 | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Death | An AE was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event was not considered to be related to study drug. Study drug includes the investigational drug under evaluation and the comparator drug or placebo that was given during any phase of the study. Adverse events starting on or after the time of the first inhalation of study drug were classified as a treatment emergent adverse event. | The safety set included all patients who received at least one dose of study drug. | Posted | Number | Participants | 52 weeks |
|
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| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period | Clinically notable hematology values were: hemoglobin - male <11.5g/dL, female <9.5 g/dL; hematocrit - male <37%, female <32%; white cell count - <2800µL or >16000µL; platelets - <7.5 10*4/µL or >70.0 10*4/µL | The safety set included all patients who received at least one dose of study drug. | Posted | Number | Participants | 52 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period | Clinically notable biochemistry values were: total protein - <4.0 g/dL or >9.5 g/dL; albumin <2.5 g/dL; bilirubin (total) >1.9 mg/dL; BUN >27 mg/dL; creatinine >1.99 mg/dL; AST >3 x ULN U/L; ALT >3 x ULN U/L; ALP >3 x ULN U/L; y-GTP >3 x ULN U/L; sodium <125 mEq/L or >160 mEq/L; potassium <3.0 mEq/L or >6.0 mEq/L; glucose <51.0 mg/dL or >180.0 mg/dL | The safety set included all patients who received at least one dose of study drug. | Posted | Number | Participants | 52 weeks |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period | Clinically notable vital sign values were: pulse rate - low, <40 bpm or <=50 bpm and decrease from baseline >=15bpm; pulse rate high, >130 bpm or >=120bpm and increase from baseline >=15 bpm. Systolic blood pressure - low, <75 mmHg or <=90 mmHg and decrease from baseline >=20 mmHg; high, >200 mmHg or >=180 mmHg and increase from baseline >=20 mmHg. Diastolic blood pressure - low, <40 mmHg or <=50 mmHg and decrease from baseline >=15 mmHg; high, >115 mmHg or >=105 mmHg and increase from baseline >=15 mmHg. | The safety set included all patients who received at least one dose of study drug. | Posted | Number | Participants | 52 weeks |
|
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| Secondary | Number of Patients With Newly Occurring or Worsening Clinically Notable Fridericia's QTc Values at Any Time-point Over the Whole Treatment Period | Clinically notable change from baseline was an increase from baseline of 30 or greater milliseconds (ms). | The safety set included all patients who received at least one dose of study drug. | Posted | Number | Participants | 52 weeks |
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| Secondary | Change in Pre-dose Forced Expiratory Volume in One Second (FEV1) From Baseline | Pre-dose FEV1 is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FEV1 value on Day 1 (Week 1). | Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. | Posted | Mean | Standard Deviation | Litres | Weeks 3, 6, 12, 24, 36, 52 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change in Pre-dose Forced Vital Capacity (FVC) From Baseline | Pre-dose FVC is defined as the average of the measurements at 45 and 15 min pre-dose. Baseline is defined as the pre-dose FVC value on Day 1 (Week 1). | Full Analysis Set (FAS) included all randomized patients who received at least one dose of study drug. | Posted | Mean | Standard Deviation | Litres | Weeks 3, 6, 12, 24, 36, 52 |
|
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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 | QVA149 | QVA149 110/50 μg once a day (o.d) | 19 | 119 | 66 | 119 | ||
| EG001 | Tiotropium | tiotropium 18 μg o.d. | 2 | 39 | 23 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmogenic right ventricular dysplasia | Congenital, familial and genetic disorders | MedDRA | Systematic Assessment |
| |
| Colonic polyp | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA | Systematic Assessment |
| |
| Anaphylactic shock | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Thrombotic cerebral infarction | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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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 pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | trialandresults.registries@novartis.com |
| 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 |
|---|---|
| C554862 | indacaterol-glycopyrronium combination |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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| Male |
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| Death |
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