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| Name | Class |
|---|---|
| Schering-Plough | INDUSTRY |
This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| indacaterol 62.5 μg | Experimental | Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. |
|
| indacaterol 125 μg | Experimental | Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. |
|
| Indacaterol 250 μg | Experimental | Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. |
|
| indacaterol 500 μg | Experimental | Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| indacaterol | Drug | Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device). |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate. | Baseline (prior to first dose) and Day 15 (24 hours after last dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose | FEV1 was measured on Day 14 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate. | Day 14, pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose. |
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Inclusion Criteria:
Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure (which include any adjustment to their current COPD treatment)
Cooperative outpatients with a diagnosis of COPD (moderate to severe as classified by the Global Initiative for Obstructive Lung Disease (GOLD) Guidelines, 2006) and:
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 | Buenos Aires | Argentina | ||||
| Novartis Investigator Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Indacaterol 62.5 μg | Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. |
| FG001 | Indacaterol 125 μg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| formoterol | Active Comparator | Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. |
|
| placebo | Placebo Comparator | Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. All participants were supplied with salbutamol/albuterol to use throughout the study as rescue medication. |
|
| formoterol | Drug | Formoterol delivered by oral inhalation via AEROLIZER® inhalation device. |
|
| placebo to indacaterol | Drug | Placebo TWISTHALER® device |
|
| placebo to formoterol | Drug | Placebo AEROLIZER® device |
|
| short acting β2- agonist | Drug | 100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI). |
|
| The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1 | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate. | Day 1 Baseline (prior to first dose) and 24 hours post-dose. |
| Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1 | FEV1 was measured on Day 1 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate. | Day 1; pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose. |
| Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14 | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1, which is taken as the maximum FEV1 recorded post-dose. | Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose |
| Change From Baseline in Morning and Evening Peak Expiratory Flow | The Peak Expiratory Flow (PEF) rate is the maximal rate that a person can exhale during a short maximal expiratory effort after fully inhaling. Participants measured their PEF using a peak flow meter prior to taking study medication and recorded measurements in a diary every morning and evening during the study. Change from baseline is the difference between the mean baseline PEF recorded during the screening period until the first day of treatment, and the overall mean PEF from Days 1 to 14. | Baseline (recorded during the screening period) and Days 1-14 (treatment period). |
| Number of Participants Using Rescue Medication | Participants recorded the use of rescue medications (salbutamol/albuterol) for treatment of asthma symptoms twice a day in a diary during the 14 days of the treatment period. | Over 14 days |
| Rosario |
| Argentina |
| Novartis Investigator Site | Santillán | Argentina |
| Novartis Investigator Site | Liège | Belgium |
| Novartis Investigator Site | Santiago | Chile |
| Novartis Investigator Site | Val Pariso | Chile |
| Novartis Investigator Site | Bois-Guillaume | France |
| Novartis Investigator Site | Clermot Ferand | France |
| Novartis Investigator Site | Lille | France |
| Novartis Investigator Site | Marseille | France |
| Novartis Investigator Site | Nantes | France |
| Novartis Investigator site | Toulouse | France |
| Novartis Investigator Site | Berlin | Germany |
| Novartis Investigator site | Bibertal | Germany |
| Novartis Investigator Site | Bochum | Germany |
| Novartis Investigator Site - 2 sites | Bonn | Germany |
| Novartis Investigator Site | Cologne | Germany |
| Novartis Investigator Site | Frankfurt | Germany |
| Novartis Investigator Site | Hamburg | Germany |
| Novartis Investigator Site | Heidelberg | Germany |
| novartis Investigator site | Koblenz | Germany |
| Novartis Investigator Site | Marburg | Germany |
| Novartis Investigator Site | Solingen | Germany |
| Novartis Investigator Site | Budapest | Hungary |
| Novartis Investigator Site | Debrecen | Hungary |
| Novartis investigator site | Pécs | Hungary |
| Novartis investigator site | Dublin | Ireland |
| Novartis Investigator Site | Genova | Italy |
| Novartis Investigator Site | Naples | Italy |
| Novartis Investigator Site | Pordenone | Italy |
| Novartis investigator site | Daugavpils | Latvia |
| Novartis Investigator Site | Riga | Latvia |
| Novartis Investigator Site | Kaunas | Lithuania |
| Novartis Investigator Site | Klaipėda | Lithuania |
| Novartis Investigator Site | Vilnius | Lithuania |
| Novartis Investigator Site | Tronheim | Norway |
| Novartis Investigator Site | Lima | Peru |
| Novartis Investigator Site | Izabelin | Poland |
| Novartis Investigator Site | Lodz | Poland |
| Novartis Investigator Site | Lublin | Poland |
| Novartis Investigator site | Mrozy | Poland |
| Novartis Investigator Site | Olsztyn | Poland |
| Novartis Investigator Site | Rzeszów | Poland |
| Novartis Investigator Site | Wejhrowo | Poland |
| Novartis Investigator Site | Włocławek | Poland |
| Novartis Investigator Site | Bucharest | Romania |
| Novartis Investigator Site | Cluj-Napoca | Romania |
| Novartis Investigator Site | Iași | Romania |
| Novartis Investigator Site | Timișoara | Romania |
| Novartis Investigator Site | Bloemfontain | South Africa |
| Novartis Investigator Site | Bloemfontein | South Africa |
| Novartis Investigator Site | Cape Town | South Africa |
| Novartis Investigator Site | Durban | South Africa |
| Novartis Investigator Site | eManzimtoti | South Africa |
| Novartis Investigator Site | George | South Africa |
| Novartis Investigator Site | Johannesburg | South Africa |
| Novartis Investigator Site | Port Elizabeth | South Africa |
| Novartis Investigator Site | Pretoria | South Africa |
| Novartis Investigator Site | Tygerberg | South Africa |
| Novartis Investigator Site | Erzurum | Turkey (Türkiye) |
| Novartis Investigator Site | Isparta | Turkey (Türkiye) |
| Novartis Investigator Site | Istanbul | Turkey (Türkiye) |
| Novartis Investigator Site | Kahramanmaraş | Turkey (Türkiye) |
| Novartis Investigator Site | Kayseri | Turkey (Türkiye) |
| Novartis Investigator Site | Malatya | Turkey (Türkiye) |
| Novartis Investigator Site | Manisa | Turkey (Türkiye) |
| Novartis Investigator Site | Sanliurfa | Turkey (Türkiye) |
| Novartis Investigator Site | Trabzon | Turkey (Türkiye) |
| Novartis Investigator Site | Belfast | United Kingdom |
| Novartis Investigator Site | Chesterfield | United Kingdom |
| Novartis Investigator Site | Glasgow | United Kingdom |
| Novartis Investigator Site | Plymouth | United Kingdom |
| Novartis Investigator Site | Warminster | United Kingdom |
| Novartis investigator site | Watford | United Kingdom |
| Novartis Investigator Site | Whitstable | United Kingdom |
Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
| FG002 | Indacaterol 250 μg | Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. |
| FG003 | Indacaterol 500 μg | Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. |
| FG004 | Formoterol | Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. |
| FG005 | Placebo | Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. |
| Safety Population |
|
| Intent to Treat Population |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Indacaterol 62.5 μg | Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. |
| BG001 | Indacaterol 125 μg | Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. |
| BG002 | Indacaterol 250 μg | Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. |
| BG003 | Indacaterol 500 μg | Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. |
| BG004 | Formoterol | Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. |
| BG005 | Placebo | Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. |
| BG006 | 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 | Total number of baseline participants is based on the Intent to Treat 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 | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 14 days of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate. | The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data. | Posted | Least Squares Mean | Standard Error | liters | Baseline (prior to first dose) and Day 15 (24 hours after last dose) |
|
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose | FEV1 was measured on Day 14 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate. | The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only. | Posted | Least Squares Mean | Standard Error | liters | Day 14, pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose. |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | The Mean Change From Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) on Day 1 | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment and region with baseline FEV1 as a covariate. | The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data. | Posted | Least Squares Mean | Standard Error | liters | Day 1 Baseline (prior to first dose) and 24 hours post-dose. |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Between Baseline (Predose) and 4 Hours Post-dose on Day 1 | FEV1 was measured on Day 1 pre-dose and up to 4 hours post-dose. The Area Under the Curve (AUC) for FEV1 was analyzed using Analysis of Covariance adjusting for treatment and region with baseline FEV1 as a covariate. | The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. Observed data only. | Posted | Least Squares Mean | Standard Error | liters | Day 1; pre-dose and at 5, 20, 30 minutes and 1, 2, 3, and 4 hours post-dose. |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Peak Forced Expiratory Volume in 1 Second (FEV1) on Day 1 and Day 14 | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Time to peak FEV1 is calculated in minutes from the time of inhalation of study drug to the time of the peak FEV1, which is taken as the maximum FEV1 recorded post-dose. | The intent-to-treat population (ITT) population consisted of all randomized patients who had a baseline and at least one post-dose FEV1 measurement. The analysis only includes patients with non-missing data, indicated by "N". | Posted | Mean | Standard Deviation | minutes | Day 1 and Day 14 measured pre-dose and up to 4 hours post-dose |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Morning and Evening Peak Expiratory Flow | The Peak Expiratory Flow (PEF) rate is the maximal rate that a person can exhale during a short maximal expiratory effort after fully inhaling. Participants measured their PEF using a peak flow meter prior to taking study medication and recorded measurements in a diary every morning and evening during the study. Change from baseline is the difference between the mean baseline PEF recorded during the screening period until the first day of treatment, and the overall mean PEF from Days 1 to 14. | Intent to treat population. The analysis only includes patients with non-missing data. | Posted | Mean | Standard Deviation | liters/minute | Baseline (recorded during the screening period) and Days 1-14 (treatment period). |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Using Rescue Medication | Participants recorded the use of rescue medications (salbutamol/albuterol) for treatment of asthma symptoms twice a day in a diary during the 14 days of the treatment period. | Intent to treat | Posted | Number | participants | Over 14 days |
|
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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 62.5 μg | Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. | 1 | 98 | 4 | 98 | ||
| EG001 | Indacaterol 125 μg | Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. | 0 | 92 | 5 | 92 | ||
| EG002 | Indacaterol 250 μg | Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. | 1 | 101 | 3 | 101 | ||
| EG003 | Indacaterol 500 μg | Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. | 2 | 96 | 4 | 96 | ||
| EG004 | Formoterol | Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. | 1 | 90 | 6 | 90 | ||
| EG005 | Placebo | Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. | 1 | 91 | 8 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| CONFUSIONAL STATE | Psychiatric disorders | 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 |
|---|---|---|---|---|---|
| NASOPHARYNGITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| HEADACHE | Nervous system 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.
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C510790 | indacaterol |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
Not provided
Not provided
| Male |
|
| OG003 | Indacaterol 500 μg | Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. |
| OG004 | Formoterol | Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. |
| OG005 | Placebo | Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. |
|
|
| OG003 | Indacaterol 500 μg | Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. |
| OG004 | Formoterol | Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. |
| OG005 | Placebo | Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. |
|
|
| OG003 | Indacaterol 500 μg | Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. |
| OG004 | Formoterol | Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. |
| OG005 | Placebo | Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. |
|
|
| OG003 | Indacaterol 500 μg | Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. |
| OG004 | Formoterol | Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. |
| OG005 | Placebo | Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. |
|
|
| OG003 | Indacaterol 500 μg | Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. |
| OG004 | Formoterol | Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. |
| OG005 | Placebo | Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. |
|
|
| OG004 | Formoterol | Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days. |
| OG005 | Placebo | Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days. |
|
|