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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002854-21 |
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This study is to evaluate if add-on treatment with inhaled NVA237 (50 µg) once daily (o.d.) via single-dose dry-powder inhaler (SDDPI) further improves lung function and health status and is well tolerated compared to placebo in symptomatic COPD patients with moderate to severe airflow limitation who are already receiving maintenance therapy with inhaled fixed-dose-combination of salmeterol/fluticasone propionate (50/500 µg) twice daily (b.i.d.) via multi-dose dry powder inhaler (MDDPI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo to NVA237 (50 μg) o.d. in the morning Patients will also receive open label salmeterol/fluticasone propionate (50/500 µg) b.i.d., in the morning and evening |
|
| NVA237 | Experimental | NVA237 (50 μg) o.d. in the morning Patients will also receive open label salmeterol/fluticasone propionate (50/500 µg) b.i.d., in the morning and evening. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVA237 | Drug | NVA237 (50µg, o.d. via SDDPI) in the morning, |
| |
| Placebo to NVA237 |
| Measure | Description | Time Frame |
|---|---|---|
| Trough Forced Expiratory Volume in 1 second (FEV1) | Comparison of NVA237 treatment versus placebo treatment in the trough FEV1 after 12 weeks of treatment | after 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Total score of St George's Respiratory Questionnaire for COPD patients (SGRQ-C). | Comparison of NVA237 treatment versus placebo treatment in terms of change in SGRQ-C after 26 weeks of treatment | 26 weeks |
| Trough Forced Expiratory Volume in 1 second (FEV1) |
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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 |
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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 |
|---|---|
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
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| Drug |
Placebo to NVA237 |
|
Comparison of effect of NVA237 treatment versus placebo treatment in FEV1 after 4 weeks and after 26 weeks of treatment |
| week 4 , week 26 |
| Total score of the Transition Dyspnea Index (TDI) | Comparison of effect of NVA237 treatment versus placebo treatment in the total TDI score after 12 weeks and after 26 weeks of treatment | Week 12 and week 26 |
| Assessment of safety and tolerability | All safety endpoints will be summarized for the safety set. | 26 Weeks |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011759 |
| Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |