Effect of Indacaterol Maleate in Chronic Obstructive Pulmonary Disease (COPD) on Lung Volume and Related Dyspnea
|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
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|