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| ID | Type | Description | Link |
|---|---|---|---|
| EUDRACT No.: 2009-013686-26 | Other Identifier | EUDRACT |
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This study is being conducted to assess the effect of indacaterol (150 μg o.d.) on inspiratory capacity (IC), using placebo and open label tiotropium (18 μg o.d.) as comparators in patients with moderate chronic obstructive pulmonary disease (COPD). In particular, spirometric timepoints are included to elucidate the peak-IC in a period of approximately 4 hour post inhalation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indacaterol - placebo - tiotropium | Experimental | In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received tiotropium 18µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. |
|
| Placebo - Tiotropium - Indacaterol | Experimental | In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received tiotropium 18µg once daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. |
|
| Tiotropium - indacaterol - placebo | Experimental | In treatment period 1, patients received tiotropium 18µg once daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indacaterol | Drug | Indacaterol 150µg once daily (o.d.) delivered via single-dose dry powder inhaler (SDDPI) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak Inspiratory Capacity (IC) After 21 Days of Treatment | IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean over the 3 values which were measured each at 30min, 2 hour, 3 hour and 4 hour post dose by body plethysmography. Analysis of variance model was used with the factors: center, period, treatment, and patients within center. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Trough IC After 20 Days of Treatment | Trough IC was measured with spirometry conducted according to internationally accepted standards. Trough IC was calculated as the mean of the three measurements of pre-dose body plethysmography (days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center. | 20 days |
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Inclusion Criteria:
Co-operative outpatients with a diagnosis of COPD (moderate as classified by the GOLD Guidelines, 2008) and including:
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 | Aschaffenburg | Germany | ||||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25280934 | Derived | Watz H, Krippner F, Kirsten A, Magnussen H, Vogelmeier C. Indacaterol improves lung hyperinflation and physical activity in patients with moderate chronic obstructive pulmonary disease--a randomized, multicenter, double-blind, placebo-controlled study. BMC Pulm Med. 2014 Oct 4;14:158. doi: 10.1186/1471-2466-14-158. |
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173 participants were screened. 129 participants entered the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tiotropium - Placebo - Indacaterol | In treatment period 1, patients received tiotropium 18µg twice daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
|
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|
| Placebo - indacaterol - tiotropium | Experimental | In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received tiotropium 18µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. |
|
| Indacaterol - tiotropium - placebo | Experimental | In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received tiotropium 18µg once daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. |
|
| Tiotropium - placebo - indacaterol | Experimental | In treatment period 1, patients received tiotropium 18µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. |
|
| Tiotropium | Drug | Tiotropium 18µg o.d. delivered via a proprietary inhalation device. |
|
| Placebo | Drug | Placebo to indacaterol o.d. delivered via SDDPI |
|
| Peak Residual Volume (RV) After 21 Days of Treatment | Peak RV was measured with spirometry conducted according to internationally accepted standards. Peak RV was calculated as the Total Lung Capacity minus the maximum of the three Inspiratory Vital Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center. | 21 days |
| Peak Total Lung Capacity (TLC) After 21 Days of Treatment | TLC was measured with spirometry conducted according to internationally accepted standards. Peak TLC was calculated as the mean of the three Functional Residual Capacity peak measurements plus the mean of the three Inspiratory Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center. | 21 days |
| Peak Residual Volume/Peak Total Lung Capacity (RV/TLC) Ratio After 21 Days of Treatment | Peak RV/TLC ratio was measured with spirometry conducted according to internationally accepted standards. Peak RV/TLC was defined as the peak RV/peak TLC. Analysis of variance model was used with the factors: center, period, treatment, and patients within center. | 21 days |
| Peak Specific Airway Resistance (sRaw) After 21 Days of Treatment | Peak sRaw was measured with spirometry conducted according to internationally accepted standards. Peak sRaw was the mean of the three measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center. | 21 days |
| FEV1 30 Minutes Post-dose After 21 Days of Treatment | FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was measured 30 minutes post-dose. Analysis of variance model was used with the factors: center, period, treatment, and patients within center. | 21 days |
| Trough Forced Expiratory Volume in 1 Second (FEV1) After 20 Days of Treatment | FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was measured pre-dose after 20 days of treatment. Analysis of variance model was used with the factors: center, period, treatment, and patients within center. | 20 days |
| Berlin |
| Germany |
| Novartis Investigative Site | Dresden | Germany |
| Novartis Investigative Site | Erfurt | Germany |
| Novartis Investigative site | Frankfurt am Main | Germany |
| Novartis Investigative Site | Fulda | Germany |
| Novartis Investigative Site | Geesthacht | Germany |
| Novartis Investigative Site | Großhansdorf | Germany |
| Novartis Investigative Site | Halle | Germany |
| Novartis Investigative Site | Hamburg | Germany |
| Novartis Investigative Site | Kiel | Germany |
| Novartis Investigative Site | Koblenz | Germany |
| Novartis Investigative site | Leipzig | Germany |
| Novartis Investigative Site | Mannheim | Germany |
| Novartis Investigative Site | Marburg | Germany |
| Novartis Investigative Site | Neumünster | Germany |
| Novartis Investigative Site | Potsdam | Germany |
| Novartis Investigative Site | Rathenow | Germany |
| Novartis Investigative Site | Rüdersdorf | Germany |
| Novartis Investigator Site | Witten | Germany |
| Novartis Investigative Site | Zerbst | Germany |
| FG001 | Indacaterol - Placebo - Tiotropium | In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received tiotropium 18µg twice daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. |
| FG002 | Indacaterol - Tiotropium - Placebo | In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received tiotropium 18µg twice daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. |
| FG003 | Placebo - Indacaterol - Tiotropium | In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received tiotropium 18µg twice daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. |
| FG004 | Placebo - Tiotropium - Indacaterol | In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received tiotropium 18µg twice daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. |
| FG005 | Tiotropium - Indacaterol - Placebo | In treatment period 1, patients received tiotropium 18µg twice daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Treatment Period 2 |
|
|
| Treatment Period 3 |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Safety Set | The safety set included all participants who received at least one dose of study medication during at least one study period. |
| 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 | Peak Inspiratory Capacity (IC) After 21 Days of Treatment | IC was measured with spirometry conducted according to internationally accepted standards. Peak IC was defined as the maximum IC of the mean over the 3 values which were measured each at 30min, 2 hour, 3 hour and 4 hour post dose by body plethysmography. Analysis of variance model was used with the factors: center, period, treatment, and patients within center. | Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 21 days were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | 21 days |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Trough IC After 20 Days of Treatment | Trough IC was measured with spirometry conducted according to internationally accepted standards. Trough IC was calculated as the mean of the three measurements of pre-dose body plethysmography (days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center. | Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 20 days were included in this analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | 20 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Peak Residual Volume (RV) After 21 Days of Treatment | Peak RV was measured with spirometry conducted according to internationally accepted standards. Peak RV was calculated as the Total Lung Capacity minus the maximum of the three Inspiratory Vital Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center. | Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 21 days were included in this analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | 21 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Peak Total Lung Capacity (TLC) After 21 Days of Treatment | TLC was measured with spirometry conducted according to internationally accepted standards. Peak TLC was calculated as the mean of the three Functional Residual Capacity peak measurements plus the mean of the three Inspiratory Capacity measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center. | Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 21 days were included in this analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | 21 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Peak Residual Volume/Peak Total Lung Capacity (RV/TLC) Ratio After 21 Days of Treatment | Peak RV/TLC ratio was measured with spirometry conducted according to internationally accepted standards. Peak RV/TLC was defined as the peak RV/peak TLC. Analysis of variance model was used with the factors: center, period, treatment, and patients within center. | Modified intent-to-treat (mITT) excluded patients from centers who performed invalid body plethysmography. Participants with observations after 21 days were included in this analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Ratio | 21 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Peak Specific Airway Resistance (sRaw) After 21 Days of Treatment | Peak sRaw was measured with spirometry conducted according to internationally accepted standards. Peak sRaw was the mean of the three measurements which were measured each at 30 min, 2 hours, 3 hours and 4 hours post dose (at days 21, 55 and 89). Analysis of variance model was used with the factors: center, period, treatment, and patients within center. | Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 21 days were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | kPa*sec | 21 days |
| |||||||||||||||||||||||||||||||||
| Secondary | FEV1 30 Minutes Post-dose After 21 Days of Treatment | FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was measured 30 minutes post-dose. Analysis of variance model was used with the factors: center, period, treatment, and patients within center. | Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 21 days were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | 21 days |
| |||||||||||||||||||||||||||||||||
| Secondary | Trough Forced Expiratory Volume in 1 Second (FEV1) After 20 Days of Treatment | FEV1 was measured with spirometry conducted according to internationally accepted standards. FEV1 was measured pre-dose after 20 days of treatment. Analysis of variance model was used with the factors: center, period, treatment, and patients within center. | Full analysis set (FAS) included all randomized patients who received at least one dose of study medication during at least one study period. Participants with observations after 20 days were included in the analysis. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | 20 days |
|
Not provided
The safety set included all participants who received at least one dose of study medication during at least one study period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Indacaterol 150ug | Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. | 1 | 118 | 20 | 118 | ||
| EG001 | Placebo | Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. | 1 | 120 | 16 | 120 | ||
| EG002 | Tiotropium 18ug | Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. | 3 | 119 | 10 | 119 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PNEUMONIA | Infections and infestations | MedDRA | Systematic Assessment |
| |
| HAND FRACTURE | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| INJURY | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| LUNG DISORDER | 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 |
| |
| RHINITIS | Infections and infestations | MedDRA | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| HYPOTENSION | Vascular 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 |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
Not provided
Not provided
| Abnormal laboratory value(s) |
|
| Adverse Event |
|
| Unsatisfactory therapeutic effect |
|
Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. |
|
|
| OG002 | Tiotropium | Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. |
|
|
| OG002 | Tiotropium | Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. |
|
|
Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. |
|
|
| OG002 |
| Tiotropium |
Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. |
|
|
Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. |
|
|
Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed. |
|
|