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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Acute Effect of Indacaterol Maleate on Static and Dynamic Lung Volume in COPD Subjects.

Conditions
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COPD, Lung Diseases, Dyspnea, Hypoxemia, Tachycardia

Intervention / Treatment
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* Drug: Indacaterol maleate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Bronchodilator<br>Indacaterol maleate 300 mcg will be administered by a third independent investigator following a randomization list. | Drug: Indacaterol maleate<br>* Dry powered, 300 mcg, only one inhalation with 24 hours duration<br>* Other names: Onbrez, Hirobriz, Onbrize, Oslif Breezehaler, Arcapta;|
| Placebo Comparator: Placebo<br>Will be administered with the same device by a third independent investigator | Drug: Placebo<br>* Dry powered, same to study drug, only one inhalation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | Arterial gas analysis will be performed evaluating all arterial gases | 60 minutes after drug inhalation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Inspiratory capacity, Residual volume, Total lung resistance, Arterial Oxygen