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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-004680-21 | EudraCT Number |
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This mechanistic study is a single-center, randomized, double-blind, placebo-controlled, cross-over study to evaluate the effect of dual bronchodilation with QVA149 on cardiac and lung function parameters in hyperinflated COPD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence 1 | Experimental | QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43 |
|
| Treatment sequence 2 | Experimental | Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QVA149 | Drug | QVA149 capsules 100/50 µg for inhalation via Concept-1-inhaler, taken once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Left Ventricular End-diastolic Volume (LVEDV) | Left ventricular enddiastolic volume (LVEDV) is a measurement of the volume of blood in the heart's left ventricular chamber at the end of the chamber's filling with blood and will be determined as measured by MRI. | Baseline, week 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Forced Expiratory Volume in One Second (FEV1). | Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by spirometry. | Baseline, week 2 |
| Change in Forced Vital Capacity (FVC). |
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Inclusion Criteria:
Exclusion Criteria:
Additional study-specific inclusion and 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 | Hanover | 30625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30641027 | Derived | Vogel-Claussen J, Schonfeld CO, Kaireit TF, Voskrebenzev A, Czerner CP, Renne J, Tillmann HC, Berschneider K, Hiltl S, Bauersachs J, Welte T, Hohlfeld JM. Effect of Indacaterol/Glycopyrronium on Pulmonary Perfusion and Ventilation in Hyperinflated Patients with Chronic Obstructive Pulmonary Disease (CLAIM). A Double-Blind, Randomized, Crossover Trial. Am J Respir Crit Care Med. 2019 May 1;199(9):1086-1096. doi: 10.1164/rccm.201805-0995OC. | |
| 29477448 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence 1 | QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43 |
| FG001 | Treatment Sequence 2 | Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| |||||||||||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence 1 | QVA149 from day 1 to day 15 followed by Placebo from day 29 to day 43 |
| BG001 | Treatment Sequence 2 | Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Left Ventricular End-diastolic Volume (LVEDV) | Left ventricular enddiastolic volume (LVEDV) is a measurement of the volume of blood in the heart's left ventricular chamber at the end of the chamber's filling with blood and will be determined as measured by MRI. | Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid LV EDV value at both baseline and post-baseline in a period were included | Posted | Mean | Standard Deviation | ML | Baseline, week 2 |
|
For the study duration of about 13 weeks
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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 (110/50) | QVA149 (110/50) | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA (20.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 9, 2016 | Apr 27, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 20, 2016 | Apr 27, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| C554862 | indacaterol-glycopyrronium combination |
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| Placebo | Drug | Placebo to QVA140 capsules 100/50 µg for inhalation via Concept-1-inhaler, taken once daily |
|
Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be assessed via spirometry. |
| Baseline, week 2 |
| Change in Inspiratory Capacity (IC) at Each Time-point | Inspiratory capacity (IC) was defined as the mean of the maximum IC over 3 values measured by bodyplethysmography according to internationally accepted standards. | Baseline, week 2 |
| Change in Total Lung Capacity (TLC) | Total Lung Capacity (TLC) will be calculated from the mean Functional Residual Capacity (FRC) plus the highest value of the Inspiratory Capacity, both measured by body plethymography according to internationally accepted standards. | Baseline, week 2 |
| Change in Residual Volume (RVol) | Residual Volume (RVol) will be calculated from the value of Total Lung Capacity (TLC) minus the highest value of the Slow Vital Capacity, both measured by body plethymography according to internationally accepted standards. | Baseline, week 2 |
| Change in Specific Airway Resistance (sRaw) | Specific Airway Resistance (sRaw) will be documented as effective resistance (sReff) calculated as the median of five acceptable measurements. Values will be measured by body plethymography according to internationally accepted standards. | Baseline, week 2 |
| Change in Functional Residual Capacity (FRC) | Functional Residual Capacity (FRC) will be calculated as the mean of three reproducible values as measured by body plethymography according to internationally accepted standards. | Baseline, week 2 |
| Change in Right Ventricular (RV) and Left Ventricular (LV) Ejection Fraction (EF) | Right and left ventricular ejection fraction is the fraction of blood (in percent) pumped out of the heart's left and right ventricular chamber, respectively, with each heart beat and will be determined as measured by MRI. | Baseline, week 2 |
| Change in Left and Right Ventricular End-systolic Volume | Right ventricular end-systolic volume (RV-ESV) and left ventricular end-systolic volume (LV-ESV) is a measurement of the volume of blood in the heart's right and left ventricular chamber, respectively, at the end of the heart's contraction and will be determined as measured by MRI. | Baseline, week 2 |
| Change in Right Ventricular Enddiastolic Volume | Right ventricular end-diastolic volume is a measurement of the volume of blood in the heart's right ventricular chamber at the end of the chamber's filling with blood and will be determined as measured by MRI. | Baseline, week 2 |
| Cardiac Output at Each Time-point, Left and Right Ventricular Cardiac Output (LVCO and RVCO) | Cardiac output is calculated as the heart rate multiplied by the stroke volume (= difference between ventricular enddiastolic volume and endsystolic volume) that will be determined as measured by MRI. | week 2 |
| Derived |
| Hohlfeld JM, Vogel-Claussen J, Biller H, Berliner D, Berschneider K, Tillmann HC, Hiltl S, Bauersachs J, Welte T. Effect of lung deflation with indacaterol plus glycopyrronium on ventricular filling in patients with hyperinflation and COPD (CLAIM): a double-blind, randomised, crossover, placebo-controlled, single-centre trial. Lancet Respir Med. 2018 May;6(5):368-378. doi: 10.1016/S2213-2600(18)30054-7. Epub 2018 Feb 21. |
| COPD exacerbation |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Placebo from day 1 to day 15 followed by QVA149 from day 29 to day 43
|
|
|
| Secondary | Change in Forced Expiratory Volume in One Second (FEV1). | Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by spirometry. | Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment | Posted | Mean | Standard Deviation | Liter | Baseline, week 2 |
|
|
|
|
| Secondary | Change in Forced Vital Capacity (FVC). | Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC will be assessed via spirometry. | Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment | Posted | Mean | Standard Deviation | Liter | Baseline, week 2 |
|
|
|
|
| Secondary | Change in Inspiratory Capacity (IC) at Each Time-point | Inspiratory capacity (IC) was defined as the mean of the maximum IC over 3 values measured by bodyplethysmography according to internationally accepted standards. | Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment | Posted | Mean | Standard Deviation | Liters | Baseline, week 2 |
|
|
|
|
| Secondary | Change in Total Lung Capacity (TLC) | Total Lung Capacity (TLC) will be calculated from the mean Functional Residual Capacity (FRC) plus the highest value of the Inspiratory Capacity, both measured by body plethymography according to internationally accepted standards. | Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment | Posted | Mean | Standard Deviation | Liters | Baseline, week 2 |
|
|
|
|
| Secondary | Change in Residual Volume (RVol) | Residual Volume (RVol) will be calculated from the value of Total Lung Capacity (TLC) minus the highest value of the Slow Vital Capacity, both measured by body plethymography according to internationally accepted standards. | Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment | Posted | Mean | Standard Deviation | Liters | Baseline, week 2 |
|
|
|
|
| Secondary | Change in Specific Airway Resistance (sRaw) | Specific Airway Resistance (sRaw) will be documented as effective resistance (sReff) calculated as the median of five acceptable measurements. Values will be measured by body plethymography according to internationally accepted standards. | Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment | Posted | Mean | Standard Deviation | kPa*s/L | Baseline, week 2 |
|
|
|
|
| Secondary | Change in Functional Residual Capacity (FRC) | Functional Residual Capacity (FRC) will be calculated as the mean of three reproducible values as measured by body plethymography according to internationally accepted standards. | Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment | Posted | Mean | Standard Deviation | Liters | Baseline, week 2 |
|
|
|
|
| Secondary | Change in Right Ventricular (RV) and Left Ventricular (LV) Ejection Fraction (EF) | Right and left ventricular ejection fraction is the fraction of blood (in percent) pumped out of the heart's left and right ventricular chamber, respectively, with each heart beat and will be determined as measured by MRI. | Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment | Posted | Mean | Standard Deviation | Percentage | Baseline, week 2 |
|
|
|
|
| Secondary | Change in Left and Right Ventricular End-systolic Volume | Right ventricular end-systolic volume (RV-ESV) and left ventricular end-systolic volume (LV-ESV) is a measurement of the volume of blood in the heart's right and left ventricular chamber, respectively, at the end of the heart's contraction and will be determined as measured by MRI. | Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment | Posted | Mean | Standard Deviation | ML | Baseline, week 2 |
|
|
|
|
| Secondary | Change in Right Ventricular Enddiastolic Volume | Right ventricular end-diastolic volume is a measurement of the volume of blood in the heart's right ventricular chamber at the end of the chamber's filling with blood and will be determined as measured by MRI. | Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment | Posted | Mean | Standard Deviation | ML | Baseline, week 2 |
|
|
|
|
| Secondary | Cardiac Output at Each Time-point, Left and Right Ventricular Cardiac Output (LVCO and RVCO) | Cardiac output is calculated as the heart rate multiplied by the stroke volume (= difference between ventricular enddiastolic volume and endsystolic volume) that will be determined as measured by MRI. | Per protocol set (PPS) included all patients in the FAS who did not have any major protocol deviations. Only patients with a valid value for parameter at both baseline and post-baseline in a period are included - Period baseline was defined as the value taken in each period prior to start of study treatment | Posted | Mean | Standard Deviation | Liter/min | week 2 |
|
|
|
|
| 59 |
| 1 |
| 59 |
| 27 |
| 59 |
| EG001 | Placebo | Placebo | 0 | 61 | 2 | 61 | 17 | 61 |
| EG002 | All Patients | All Patients | 0 | 62 | 2 | 62 | 40 | 62 |
| Hepatic enzyme increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (20.0) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | 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 or disclosure of trial results in their entirety.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| RV-EF |
|
|
| 0.1732 |
| Mean Difference (Net) |
| 1.131 |
| 2-Sided |
| 95 |
| -0.512 |
| 2.774 |
| Superiority |
| RV-ESV |
|
|
| 0.1236 |
| Mean Difference (Net) |
| 2.095 |
| 2-Sided |
| 95 |
| -0.591 |
| 4.782 |
| Superiority |
| RVCO |
|
|
| 0.0182 |
| Mean Difference (Net) |
| 0.281 |
| 2-Sided |
| 95 |
| 0.050 |
| 0.512 |
| Superiority |