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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
Sponsor:
Collaborator:
Fondazione Salvatore Maugeri
Information provided by (Responsible Party):
Pierachille Santus, University of Milan

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
COPD Lung Diseases Dyspnea Hypoxemia Tachycardia Drug: Indacaterol maleate Drug: Placebo Phase 4

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

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Arms and Interventions
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Arm Intervention/treatment
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
 Drug: Placebo
Dry powered, same to study drug, only one inhalation


Outcome Measures
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Primary Outcome Measures :
  1. Intra Thoracic Gas Volume (ITGV) [ Time Frame: 60 minutes after drug inhalation ]
    A complete body plethysmografic test will be performed after indacaterol inhalation


Secondary Outcome Measures :
  1. 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).

  2. Partial pressure of arterial oxygen (PaO2) [ Time Frame: 60 minutes after drug inhalation ]
    Arterial gas analysis will be performed evaluating all arterial gases


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Italy
Pneumologia Riabilitativa - Fondazione Maugeri - Istituto Scientifico di Milano - IRCCS
Milano, Italy, 20138
Sponsors and Collaborators
University of Milan
Fondazione Salvatore Maugeri
Investigators
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Study Director: Pierachille Santus, MD, PhD Università degli Studi di Milano-Pneumologia Riabilitativa- Fondazione Maugeri-Istituto Scientifico di Milano-IRCCS - pierachille.santus@unimi.it
More Information
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Responsible Party: Pierachille Santus, MD, PhD, University of Milan
ClinicalTrials.gov Identifier: NCT01377051    
Other Study ID Numbers: 654CEC
First Posted: June 20, 2011    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014
Keywords provided by Pierachille Santus, University of Milan:
COPD
Inspiratory capacity
Residual volume
Total lung resistance
Arterial Oxygen
Additional relevant MeSH terms:
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Lung Diseases
Dyspnea
Tachycardia
Hypoxia
Respiratory Tract Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
 Cardiac Conduction System Disease
Pathologic Processes
Respiration Disorders
Signs and Symptoms, Respiratory
Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action