Effect of Indacaterol Maleate in Chronic Obstructive Pulmonary Disease (COPD) on Lung Volume and Related Dyspnea
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01377051|
Recruitment Status : Completed
First Posted : June 20, 2011
Last Update Posted : October 29, 2014
|Condition or disease||Intervention/treatment||Phase|
|COPD Lung Diseases Dyspnea Hypoxemia Tachycardia||Drug: Indacaterol maleate Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Acute Effect of Indacaterol Maleate on Static and Dynamic Lung Volume in COPD Subjects.|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||September 2011|
Active Comparator: Bronchodilator
Indacaterol maleate 300 mcg will be administered by a third independent investigator following a randomization list.
Drug: Indacaterol maleate
Dry powered, 300 mcg, only one inhalation with 24 hours duration
Other Name: Onbrez, Hirobriz, Onbrize, Oslif Breezehaler, Arcapta
Placebo Comparator: Placebo
Will be administered with the same device by a third independent investigator
Dry powered, same to study drug, only one inhalation
- Intra Thoracic Gas Volume (ITGV) [ Time Frame: 60 minutes after drug inhalation ]A complete body plethysmografic test will be performed after indacaterol inhalation
- Forced Expired Volume in the first second (FEV1) [ Time Frame: 60 minutes after drug inhalation ]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).
- Partial pressure of arterial oxygen (PaO2) [ Time Frame: 60 minutes after drug inhalation ]Arterial gas analysis will be performed evaluating all arterial gases
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01377051
|Pneumologia Riabilitativa - Fondazione Maugeri - Istituto Scientifico di Milano - IRCCS|
|Milano, Italy, 20138|
|Study Director:||Pierachille Santus, MD, PhD||Università degli Studi di Milano-Pneumologia Riabilitativa- Fondazione Maugeri-Istituto Scientifico di Milano-IRCCS - firstname.lastname@example.org|