Effect of Indacaterol Maleate in Chronic Obstructive Pulmonary Disease (COPD) on Lung Volume and Related Dyspnea
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.
Drug: Indacaterol maleate
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Acute Effect of Indacaterol Maleate on Static and Dynamic Lung Volume in COPD Subjects.|
- Intra Thoracic Gas Volume (ITGV) [ Time Frame: 60 minutes after drug inhalation ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Arterial gas analysis will be performed evaluating all arterial gases
|Study Start Date:||May 2011|
|Study Completion Date:||September 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
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
Other Name: Placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|