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In this 12-week study, patients were randomized to either open-label indacaterol or standard of care for Chronic Obstructive Pulmonary Disease (COPD) treatment; efficacy and safety were assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Indacaterol | Experimental | Indacaterol 150 µg once-daily via single-dose dry powder inhaler |
|
| Long-acting beta2-agonist | Active Comparator | Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indacaterol | Drug | Indacaterol 150 µg once-daily via single-dose dry powder inhaler |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline on Clinical COPD Questionnaire (CCQ) Score | The Clinical Chronic Obstructive Pulmonary disease (COPD) Questionnaire (CCQ) is a self-administered questionnaire containing ten questions, divided into three domains: symptoms, mental and functional state. The questions are based on a 7-point scale where a '0' means having no limitations and a '6' means extreme or complete limitations. The final score is the mean of all ten questions. The CCQ score was recalculated according to the paper by Van der Molen et al., 2003. The statistical significance remained the same. | Baseline and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Afula | Israel | ||||
| Novartis Investigative Site |
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90 participants were screened and enrolled into the study. The participants were randomized in a 2:1 ratio. Out of 90 participants randomized, 87 received study drug and were included in the Safety set for analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Indacaterol | indacaterol 150 µg once-daily via single-dose dry powder inhaler |
| FG001 | Long-acting beta2-agonist | Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Indacaterol | indacaterol 150 µg once-daily via single-dose dry powder inhaler |
| BG001 | Long-acting beta2-agonist | Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change From Baseline on Clinical COPD Questionnaire (CCQ) Score | The Clinical Chronic Obstructive Pulmonary disease (COPD) Questionnaire (CCQ) is a self-administered questionnaire containing ten questions, divided into three domains: symptoms, mental and functional state. The questions are based on a 7-point scale where a '0' means having no limitations and a '6' means extreme or complete limitations. The final score is the mean of all ten questions. The CCQ score was recalculated according to the paper by Van der Molen et al., 2003. The statistical significance remained the same. | Full analysis Set: all patients who received at least one dose of study drug and have evaluable data for analysis. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 weeks |
|
Entire duration of study
Out of 90 participants randomized, 87 received study drug and were included in the safety set for analysis.
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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 | indacaterol 150 µg once-daily via single-dose dry powder inhaler |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis | 41 61 324 1111 |
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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 |
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| Long-acting beta2-agonist |
| Drug |
Long-acting beta2-agonist (LABA) bronchodilator monotherapy via inhaler twice daily |
|
| Ashkelon |
| Israel |
| Novartis Investigative Site | Holon | Israel |
| Novartis Investigative Site | Jerusalem | Israel |
| Novartis Investigative Site | Kfar Saba | Israel |
| Novartis Investigative Site | Petah Tikva | Israel |
| Novartis Investigative Site | Rehovot | Israel |
| Novartis Investigative Site | Tel Aviv | Israel |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Long-acting beta2-agonist | Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy |
|
|
| 3 |
| 59 |
| 9 |
| 59 |
| EG001 | Long-acting beta2-agonist | Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy | 0 | 28 | 4 | 28 |
| Pericarditis | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Ventricular fibrillation | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Brain stem haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal 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 |
|
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.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |