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The purpose of this study is to further figure out differences of glycopyrronium bromide compared to tiotropium in early bronchodilation measured by a comprehensive assessment of lung function that includes hyperinflation and specific airway resistance in patients with moderate to severe COPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVA237 followed by tiotropium | Experimental | Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication. |
|
| Tiotropium followed by NVA237 | Experimental | Period 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVA237 | Drug | NVA237 44 µg inhalation capsules once daily, delivered via single-dose dry-powder inhaler (SDDPI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-2 | Standardized Forced Expiratory Volume in One Second (FEV1) AUC0-2h will be measured via spirometry. The AUC will be calculated from the FEV1 measurements obtained at timepoints between 0 min and 2h using the trapezoidal rule and will be standardized (=divided) by the measurement time (i.e. 2h). | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in One Second (FEV1) 15 Min Post Dose | Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. | Day 1 |
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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 | Leipzig | Germany | 04207 | Germany | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27940287 | Derived | Watz H, Mailander C, May C, Baier M, Kirsten AM. Fast onset of action of glycopyrronium compared with tiotropium in patients with moderate to severe COPD - A randomised, multicentre, crossover trial. Pulm Pharmacol Ther. 2017 Feb;42:13-20. doi: 10.1016/j.pupt.2016.12.001. Epub 2016 Dec 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NVA237 Followed by Tiotropium | Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication. |
| FG001 | Tiotropium Followed by NVA237 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| PERIOD 1 |
|
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| Tiotropium | Drug | Tiotropium 18 μg once daily delivered via HandiHaler® device. |
|
| Placebo to NVA237 | Drug | Placebo to NVA237 once daily, delivered via single-dose dry-powder inhaler (SDDPI). |
|
| Placebo to tiotropium | Drug | Placebo to tiotropium once daily delivered via HandiHaler® device |
|
| Salbutamol | Drug | Used as resuce medication |
|
| Specific Airway Resistance (sRAW) | Specific Airway Resistance (sRAW) indicates volume and resistance-dependent work of breathing needed in order to generate a reference flow rate of 1 L/s, measured by kPa*s. Whole body plethysmography (Bodybox) is used to measure SRaw. | Day 1 |
| Functional Resistance Capacity (FRCpleth) | Functional Resistance Capacity (FRCpleth) will be measured using whole body plethysmography (Bodybox). | Day 1 |
| Residual Volume (RV) | Residual Volume (RV) will be measured using whole body plethysmography (Bodybox). | Day 1 |
| Total Lung Capacity (TLC) | Total Lung Capacity (TLC) is the best vital capacity plus residual volume (RV). Whole body plethysmography (Bodybox) will be used to measure TLC. | Day 1 |
| Inspiratory Capacity (IC) | Inspiratory Capacity (IC) is the volume of air breathed in by a maximum inspiration at the end of a normal expiration. Whole body plethysmography (Bodybox) will be used to measure IC. | Day 1 |
| Berlin |
| 12043 |
| Germany |
| Novartis Investigative Site | Berlin | 12203 | Germany |
| Novartis Investigative Site | Berlin | 12687 | Germany |
| Novartis Investigative Site | Berlin | 13086 | Germany |
| Novartis Investigative Site | Frankfurt | 60596 | Germany |
| Novartis Investigative Site | Gelsenkirchen | 45879 | Germany |
| Novartis Investigative Site | Großhansdorf | 22947 | Germany |
| Novartis Investigative Site | Gummersbach | 51643 | Germany |
| Novartis Investigative Site | Hamburg | 20354 | Germany |
| Novartis Investigative Site | Kassel | 34121 | Germany |
| Novartis Investigative Site | Lübeck | 23552 | Germany |
| Novartis Investigative Site | Rüdersdorf | 15562 | Germany |
| Novartis Investigative Site | Sonneberg | 96515 | Germany |
Period 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication. |
| COMPLETED |
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| NOT COMPLETED |
|
| WASHOUT Period |
|
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| PERIOD 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NVA237 Followed by Tiotropium | Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication. |
| BG001 | Tiotropium Followed by NVA237 | Period 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication. |
| 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 | Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-2 | Standardized Forced Expiratory Volume in One Second (FEV1) AUC0-2h will be measured via spirometry. The AUC will be calculated from the FEV1 measurements obtained at timepoints between 0 min and 2h using the trapezoidal rule and will be standardized (=divided) by the measurement time (i.e. 2h). | The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period. | Posted | Mean | Standard Deviation | liters per hour | Day 1 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Forced Expiratory Volume in One Second (FEV1) 15 Min Post Dose | Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. FEV1 will be measured by spirometry. All spirometry calibrations and evaluations will follow the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability. | The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period. | Posted | Mean | Standard Deviation | liters per hour | Day 1 |
|
| |||||||||||||||||||||||||||||
| Secondary | Specific Airway Resistance (sRAW) | Specific Airway Resistance (sRAW) indicates volume and resistance-dependent work of breathing needed in order to generate a reference flow rate of 1 L/s, measured by kPa*s. Whole body plethysmography (Bodybox) is used to measure SRaw. | The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period. | Posted | Mean | Standard Deviation | kilopascal (kPa) | Day 1 |
|
| |||||||||||||||||||||||||||||
| Secondary | Functional Resistance Capacity (FRCpleth) | Functional Resistance Capacity (FRCpleth) will be measured using whole body plethysmography (Bodybox). | The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period. | Posted | Mean | Standard Deviation | Liters | Day 1 |
|
| |||||||||||||||||||||||||||||
| Secondary | Residual Volume (RV) | Residual Volume (RV) will be measured using whole body plethysmography (Bodybox). | The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period. | Posted | Mean | Standard Deviation | Liters | Day 1 |
|
| |||||||||||||||||||||||||||||
| Secondary | Total Lung Capacity (TLC) | Total Lung Capacity (TLC) is the best vital capacity plus residual volume (RV). Whole body plethysmography (Bodybox) will be used to measure TLC. | The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period. | Posted | Mean | Standard Deviation | Liters | Day 1 |
|
| |||||||||||||||||||||||||||||
| Secondary | Inspiratory Capacity (IC) | Inspiratory Capacity (IC) is the volume of air breathed in by a maximum inspiration at the end of a normal expiration. Whole body plethysmography (Bodybox) will be used to measure IC. | The Full Analysis Set (FAS) consisted of all randomized patients who applied at least one dose of study medication during at least one study period. | Posted | Mean | Standard Deviation | Liters | Day 1 |
|
|
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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 | NVA237 | ALL patients on NVA237 for Period 1 & Period 2 | 2 | 152 | 8 | 152 | ||
| EG001 | Tiotropium | ALL patients onTiotropium for Period 1 & Period 2 | 2 | 151 | 15 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Nephrectomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Condition aggravated | General disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system 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 |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | 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 or disclosure of trial results in their entirety.
| 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 |
|---|---|
| D006024 | Glycopyrrolate |
| D000069447 | Tiotropium Bromide |
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D000470 | Alkaloids |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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| Male |
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