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

University of Milan60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

COPD Lung Diseases Dyspnea Hypoxemia Tachycardia

Interventions

Indacaterol maleateDRUG

Dry powered, 300 mcg, only one inhalation with 24 hours duration

PlaceboDRUG

Dry powered, same to study drug, only one inhalation

Eligibility

Sex: ALLMin age: 50 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signature of consensus * COPD diagnosis * Age from 50 to 85 years old * history of COPD at least of one year * respiratory stable conditions at least of one month * Any basal FEV1 expressed in % of predicted value * FEV1/ Forced Vital Capacity (FVC) less than 70% * Former or active smokers with at least a smoking history of 20 pack year Exclusion Criteria: * Pregnancy * FEV1/FVC more than 70% * Known deficit of alpha 1 antitrypsin * Subjects submitted to a Lung Volume Reduction Surgery (LVRS) * Subjects with known positivity to Human Immunodeficiency Virus (HIV) * Misuse of alcool or drugs * Absence of compliance in performing respiratory tests

Locations (1)

Pneumologia Riabilitativa - Fondazione Maugeri - Istituto Scientifico di Milano - IRCCS

Milan, Italy

Outcomes

Primary Outcomes

Intra Thoracic Gas Volume (ITGV)

A complete body plethysmografic test will be performed after indacaterol inhalation

Time frame: 60 minutes after drug inhalation

Secondary Outcomes

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).

Time frame: 60 minutes after drug inhalation

Partial pressure of arterial oxygen (PaO2)

Arterial gas analysis will be performed evaluating all arterial gases

Time frame: 60 minutes after drug inhalation

Data from ClinicalTrials.gov

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