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An investigational inhalation product (QVA149) for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) is being developed. This 14 day study will investigate the effect on heart rate and cardiovascular effects to ensure the product is safe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| indacaterol/glycopyrrolate 600/100 μg | Experimental | Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
|
| indacaterol/glycopyrrolate 300/100 μg | Experimental | One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
|
| indacaterol/glycopyrrolate 150/100 μg | Experimental | One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
|
| indacaterol 300 μg | Active Comparator | One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| indacaterol/glycopyrrolate | Drug | Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean 24 Hour Heart Rate at Day 14 | Heart rate was assessed by Holter monitoring and was measured over a 24 hour period at day 14. Heart rate was defined as the average value over the 24 hour monitoring period. The baseline measurement was the average heart rate taken from the 24 hour Holter monitoring period performed at screening or the last 24-hour period before taking the first dose of study drug. Least square means are based on the analysis of covariance: 24 hours mean heart rate = center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 min post salbutamol/albuterol + error. | Baseline, Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean 24 Hour Heart Rate at Day 1 | Heart rate was assessed by Holter monitoring and was measured over a 24 hour period at day 1. Heart rate was defined as the average value over the 24 hour monitoring period. The baseline measurement was the average heart rate taken from the 24 hour Holter monitoring period performed at screening or the last 24-hour period before taking the first dose of study drug. Least squares means are based on the analysis of covariance: 24 hours mean heart rate = center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 min after inhalation of salbutamol/albuterol + error. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharma AG | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator Site | Adelaide | Australia | ||||
| Novartis Investigator Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Indacaterol/Glycopyrrolate 600 μg/100 μg | Two capsules indacaterol/glycopyrrolate 300 μg/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
| FG001 | Indacaterol/Glycopyrrolate 300 μg/100 μg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| placebo | Placebo Comparator | Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
|
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| indacaterol | Drug | Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days. |
|
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| glycopyrrolate | Drug | Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days. |
|
| placebo | Drug | Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days. |
|
| Baseline, Day 1 |
| Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Day 14 | Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the mean of two measurements at 23 hours 15 minutes and 23 hour 45 minutes post dosing. Baseline is defined as the mean of the two values taken at 45 minutes and 15 minutes prior to dosing at day 1. Least square means are based on the analysis of covariance: response variable=center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 minutes post inhalation of salbutamol/albuterol. | Day 1, Day 14 |
| Trough Forced Vital Capacity (FVC) at Day 1 and Day 14 | Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FVC was defined as the mean of two measurements at 23 hours 15 minutes and the 23 hours 45 minutes post dosing. Baseline was defined as the mean of the two values taken at 45 minutes and 15 minutes prior to dosing at day 1. Analysis of covariance: FVC parameter = center + treatment + baseline FVC + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min after inhalation of salbutamol/albuterol + error. | Day 1 and Day 14 |
| Change From Baseline in QTc (Fridericia's Formula) at Day 1 | The change from baseline in QTc at 30 minutes, 4 hours and 23 hours 45 minutes post dose on day 1. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia's formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min post inhalation of salbutamol/albuterol. | Baseline, Day 1 |
| Change From Baseline in QTc (Fridericia's Formula) at Day 7 | The change from baseline in QTc at 30 minutes and 2 hours post dose on day 7. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia's formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min post inhalation of salbutamol/albuterol. | Baseline, Day 7 |
| Change From Baseline in QTc (Fridericia's Formula) at Day 14 | The change from baseline in QTc at 30 minutes, 4 hours and 23 hours 45 minutes post dose on day 14. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia's formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 minutes post inhalation of salbutamol/albuterol. | Baseline, Day 14 |
| Clayton |
| Australia |
| Novartis Investigator Site | Daw Park | Australia |
| Novartis Investigator site | Heidelberg | Australia |
| Novartis Investigator Site | Nedlands | Australia |
| Novartis Investigator Site | Brussels | Belgium |
| Novartis Investigator Site | Jambes | Belgium |
| Novartis Investigator Site | Jette | Belgium |
| Novartis Investigator site | Liège | Belgium |
| Novartis Investigator Site | Ostend | Belgium |
| Novartis Investigator Site | Mississauga | Canada |
| Novartis Investigator Site | Newmarket | Canada |
| Novartis Investigator Site | Ottawa | Canada |
| Novartis Investigator Site | Pointe-Claire | Canada |
| Novartis Investigator Site | Québec | Canada |
| Novartis Investigator Site | Sainte-Foy | Canada |
| Novartis Investigator Site | Ambroise | France |
| Novartis Investigator Site | Lille | France |
| Novartis Investigator Site | Marseille | France |
| Novartis investigator site | Martigues | France |
| Novartis Investigator Site | Nantes | France |
| Novartis Investigator site | Nice | France |
| Novartis Investigator Site | Perpignan | France |
| Novartis Investigator Site | Berlin | Germany |
| Novartis Investigator Site | Dortmund | Germany |
| Novartis Investigator Site | Erfurt | Germany |
| Novartis Investigator Site | Hanover | Germany |
| Novartis Investigator Site | Mainz | Germany |
| Novartis Investigator Site | Marburg | Germany |
| Novartis Investigator Site | Florence | Italy |
| Novartis Investigator site | Modena | Italy |
| Novartis Investigator Site | Trieste | Italy |
| Novartis Investigator Site | Badalona | Spain |
| Novartis Investigator Site | Barakaldo | Spain |
| Novartis Investigator Site | Cáceres | Spain |
| Novartis Investigator Site | Centelles | Spain |
| Novartis Investigator Site | Mataró | Spain |
| Novartis Investigator Site | Valencia | Spain |
| Novartis Investigator Site | Istanbul | Turkey (Türkiye) |
| Novartis Investigator Site | Izmir | Turkey (Türkiye) |
One capsule indacaterol/glycopyrrolate 300 μg/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
| FG002 | Indacaterol/Glycopyrrolate 150 μg/100 μg | One capsule indacaterol/glycopyrrolate 150 μg/50 μg and one capsule 50μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
| FG003 | Indacaterol 300 μg | One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
| FG004 | Placebo | Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
| Safety: Received Study Drug |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Indacaterol/Glycopyrrolate 600/100 μg | Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
| BG001 | Indacaterol/Glycopyrrolate 300/100 μg | One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
| BG002 | Indacaterol/Glycopyrrolate 150/100 μg | One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
| BG003 | Indacaterol 300 μg | One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
| BG004 | Placebo | Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
| BG005 | 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 | Overall Number of Baseline Participants is based on the Safety Population | 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 | Change From Baseline in Mean 24 Hour Heart Rate at Day 14 | Heart rate was assessed by Holter monitoring and was measured over a 24 hour period at day 14. Heart rate was defined as the average value over the 24 hour monitoring period. The baseline measurement was the average heart rate taken from the 24 hour Holter monitoring period performed at screening or the last 24-hour period before taking the first dose of study drug. Least square means are based on the analysis of covariance: 24 hours mean heart rate = center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 min post salbutamol/albuterol + error. | Safety Population includes all patients who received at least one dose of study drug. Participants with less than 18 hours quality recording time data were excluded from this analysis. | Posted | Least Squares Mean | Standard Error | beats per minute | Baseline, Day 14 |
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| Secondary | Change From Baseline in Mean 24 Hour Heart Rate at Day 1 | Heart rate was assessed by Holter monitoring and was measured over a 24 hour period at day 1. Heart rate was defined as the average value over the 24 hour monitoring period. The baseline measurement was the average heart rate taken from the 24 hour Holter monitoring period performed at screening or the last 24-hour period before taking the first dose of study drug. Least squares means are based on the analysis of covariance: 24 hours mean heart rate = center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 min after inhalation of salbutamol/albuterol + error. | Safety Population includes all patients who received at least one dose of study drug. Participants with less than 18 hours quality recording time data were excluded from this analysis. | Posted | Least Squares Mean | Standard Error | beats per minute | Baseline, Day 1 |
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| Secondary | Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Day 14 | Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FEV1 was defined as the mean of two measurements at 23 hours 15 minutes and 23 hour 45 minutes post dosing. Baseline is defined as the mean of the two values taken at 45 minutes and 15 minutes prior to dosing at day 1. Least square means are based on the analysis of covariance: response variable=center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 minutes post inhalation of salbutamol/albuterol. | Intent-to-treat Population includes all randomized patients. Any spirometric data collected less than six hours after rescue medication use was regarded as missing. | Posted | Least Squares Mean | Standard Error | Liters | Day 1, Day 14 |
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| Secondary | Trough Forced Vital Capacity (FVC) at Day 1 and Day 14 | Spirometry testing was performed in accordance with American Thoracic Society standards. Trough FVC was defined as the mean of two measurements at 23 hours 15 minutes and the 23 hours 45 minutes post dosing. Baseline was defined as the mean of the two values taken at 45 minutes and 15 minutes prior to dosing at day 1. Analysis of covariance: FVC parameter = center + treatment + baseline FVC + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min after inhalation of salbutamol/albuterol + error. | Participants from the Intent-to-treat Population (all randomized patients) with data available at the given time-point. Any spirometric data collected less than six hours after rescue medication use was regarded as missing. | Posted | Least Squares Mean | Standard Error | Liters | Day 1 and Day 14 |
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| Secondary | Change From Baseline in QTc (Fridericia's Formula) at Day 1 | The change from baseline in QTc at 30 minutes, 4 hours and 23 hours 45 minutes post dose on day 1. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia's formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min post inhalation of salbutamol/albuterol. | Safety Population includes all patients who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | milliseconds | Baseline, Day 1 |
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| Secondary | Change From Baseline in QTc (Fridericia's Formula) at Day 7 | The change from baseline in QTc at 30 minutes and 2 hours post dose on day 7. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia's formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min post inhalation of salbutamol/albuterol. | Safety Population includes all patients who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | milliseconds | Baseline, Day 7 |
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| Secondary | Change From Baseline in QTc (Fridericia's Formula) at Day 14 | The change from baseline in QTc at 30 minutes, 4 hours and 23 hours 45 minutes post dose on day 14. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia's formula: QTc = QT / 3√ RR. Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 minutes post inhalation of salbutamol/albuterol. | Safety Population includes all patients who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | milliseconds | Baseline, Day 14 |
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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/Glycopyrrolate 600/100 μg | Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. | 2 | 49 | 5 | 49 | ||
| EG001 | Indacaterol/Glycopyrrolate 300/100 μg | One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. | 0 | 51 | 6 | 51 | ||
| EG002 | Indacaterol/Glycopyrrolate 150/100 μg | One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. | 2 | 51 | 10 | 51 | ||
| EG003 | Indacaterol 300 μg | One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. | 0 | 51 | 7 | 51 | ||
| EG004 | Placebo | Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol /albuterol as rescue medication was permitted throughout the study. | 1 | 53 | 4 | 53 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
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| Blood potassium increased | Investigations | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Headache | Nervous system 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 |
| |
| Hypertension | Vascular 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 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 |
| D006024 | Glycopyrrolate |
| C554862 | indacaterol-glycopyrronium combination |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
|
| OG002 | Indacaterol/Glycopyrrolate 150/100 μg | One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
| OG003 | Indacaterol 300 μg | One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
| OG004 | Placebo | Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
|
|
| OG002 | Indacaterol/Glycopyrrolate 150/100 μg | One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
| OG003 | Indacaterol 300 μg | One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
| OG004 | Placebo | Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
|
|
| OG002 | Indacaterol/Glycopyrrolate 150/100 μg | One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
| OG003 | Indacaterol 300 μg | One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
| OG004 | Placebo | Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
|
|
One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
| OG003 | Indacaterol 300 μg | One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
| OG004 | Placebo | Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
|
|
One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
| OG003 | Indacaterol 300 μg | One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
| OG004 | Placebo | Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
|
|
One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
| OG003 | Indacaterol 300 μg | One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
| OG004 | Placebo | Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
|
|