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| Name | Class |
|---|---|
| Fondazione Salvatore Maugeri | OTHER |
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The purpose of this study is to determine whether indacaterol maleate 300 micrograms (mcg) is effective in the acute treatment of COPD and in particular on reducing lung hyperinflation and dynamic volumes.
Enrolled patients: COPD of any disease severity in stable conditions. 48 hours of inhalatory drugs wash out.
Evaluation: Plethysmographic test, blood gas analysis, blood pressure, cardiac frequency and Borg scale evaluation in basal condition and after 60 minutes of indacaterol maleate 300 mcg inhalation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bronchodilator | Active Comparator | Indacaterol maleate 300 mcg will be administered by a third independent investigator following a randomization list. |
|
| Placebo | Placebo Comparator | Will be administered with the same device by a third independent investigator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indacaterol maleate | Drug | Dry powered, 300 mcg, only one inhalation with 24 hours duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intra Thoracic Gas Volume (ITGV) | A complete body plethysmografic test will be performed after indacaterol inhalation | 60 minutes after drug inhalation |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expired Volume in the first second (FEV1) | Will be performed: spirometry, Arterial blood sample, measurement of blood pressure and cardiac frequency. All these parameters will be tested 60 minutes after inhalation of Indacaterol 300 micrograms (mcg). | 60 minutes after drug inhalation |
| Partial pressure of arterial oxygen (PaO2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierachille Santus, MD, PhD | Università degli Studi di Milano-Pneumologia Riabilitativa- Fondazione Maugeri-Istituto Scientifico di Milano-IRCCS - pierachille.santus@unimi.it | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pneumologia Riabilitativa - Fondazione Maugeri - Istituto Scientifico di Milano - IRCCS | Milan | 20138 | Italy |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D008171 | Lung Diseases |
| D004417 | Dyspnea |
| D000860 | Hypoxia |
| D013610 | Tachycardia |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| C510790 | indacaterol |
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| Placebo | Drug | Dry powered, same to study drug, only one inhalation |
|
Arterial gas analysis will be performed evaluating all arterial gases |
| 60 minutes after drug inhalation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |