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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013763-19 | EudraCT Number |
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This study compared the effects of a single dose of indacaterol with that of a single dose of tiotropium on inspiratory capacity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indacaterol 150 μg-tiotropium 18 μg-placebo | Experimental | Patients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
|
| Tiotropium 18 μg-placebo-indacaterol 150 μg | Experimental | Patients received tiotropium 18 μg once. After a 5-9 days washout period, patients received placebo (matching indacaterol) once. After a second 5-9 days washout period, patients received indacaterol 150 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
|
| Placebo-indacaterol 150 μg-tiotropium 18 μg | Experimental | Patients received placebo (matching indacaterol) once. After a 5-9 days washout period, patients received indacaterol 150 μg once. After a second 5-9 days washout period, patients received tiotropium 18 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indacaterol 150 μg | Drug | Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment | During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured 3 times each at 30, 60, 120, 180, and 240 minutes post-dose and the highest value was reported in liters. | 4 hour period following inhalation of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment | FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. |
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Inclusion Criteria:
Diagnosis of moderate (as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2007) chronic obstructive pulmonary disease (COPD) and:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria applied to the study.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Bergamo | Italy | ||||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22035851 | Derived | Rossi A, Centanni S, Cerveri I, Gulotta C, Foresi A, Cazzola M, Brusasco V. Acute effects of indacaterol on lung hyperinflation in moderate COPD: a comparison with tiotropium. Respir Med. 2012 Jan;106(1):84-90. doi: 10.1016/j.rmed.2011.09.006. Epub 2011 Oct 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Indacaterol 150 μg-tiotropium 18 μg-placebo | Patients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| FG001 | Tiotropium 18 μg-placebo-indacaterol 150 μg | Patients received tiotropium 18 μg once. After a 5-9 days washout period, patients received placebo (matching indacaterol) once. After a second 5-9 days washout period, patients received indacaterol 150 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| FG002 | Placebo-indacaterol 150 μg-tiotropium 18 μg | Patients received placebo (matching indacaterol) once. After a 5-9 days washout period, patients received indacaterol 150 μg once. After a second 5-9 days washout period, patients received tiotropium 18 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Treatment Period 2 |
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| Treatment Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population | The entire study population includes the 3 groups of patients who received indacaterol 150 μg, tiotropium 18 μg, and placebo (matching indacaterol) once each in 1 of 3 different orders in this crossover study. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment | During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured 3 times each at 30, 60, 120, 180, and 240 minutes post-dose and the highest value was reported in liters. | Per protocol population: All randomized patients who received all the study drugs and had at least 1 post-dose inspiratory capacity measurement within 4 hours after inhalation in each treatment period and who were compliant with the protocol and without any major deviation likely to affect the analysis of pulmonary function measurements. | Posted | Mean | Standard Deviation | Liters | 4 hour period following inhalation of study treatment |
|
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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 150 μg | Patients received indacaterol 150 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862 778-8300 |
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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 |
|---|---|
| C510790 | indacaterol |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
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| Tiotropium 18 μg | Drug | Tiotropium was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device. |
|
| Placebo | Drug | Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device. |
|
| 4 hour period following inhalation of study treatment |
| Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment | FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. | 4 hour period following inhalation of study treatment |
| Brescia |
| Italy |
| Novartis Investigative Site | Cava de' Tirreni | Italy |
| Novartis Investigative Site | Genova | Italy |
| Novartis Investigative Site | Milan | Italy |
| Novartis Investigative Site | Orbassano | Italy |
| Novartis Investigative Site | Pavia | Italy |
| Novartis Investigative Site | Reggio Emilia | Italy |
| Novartis Investigative Site | Sesto San Giovanni | Italy |
| Novartis Investigative Site | Treviso | Italy |
| Novartis Investigative Site | Verona | Italy |
| NOT COMPLETED |
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| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Tiotropium 18 μg | Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
| OG002 | Placebo | Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study. |
|
|
| Secondary | Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment | FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. | Intent-to-treat population: All randomized patients who received all the study drugs and had at least 1 post-dose inspiratory capacity measurement within 4 hours after inhalation in each treatment period. | Posted | Mean | Standard Deviation | Liters | 4 hour period following inhalation of study treatment |
|
|
|
| Secondary | Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment | FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time. | Intent-to-treat population: All randomized patients who received all the study drugs and had at least 1 post-dose inspiratory capacity measurement within 4 hours after inhalation in each treatment period. | Posted | Mean | Standard Deviation | Liters | 4 hour period following inhalation of study treatment |
|
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|
| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | Tiotropium 18 μg | Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study. | 0 | 52 | 0 | 52 |
| EG002 | Placebo | Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study. | 0 | 51 | 0 | 51 |
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 (ie, data from all sites) in the clinical trial.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |