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

This study has been completed.
Sponsor:
Collaborator:
Fondazione Salvatore Maugeri
Information provided by (Responsible Party):
Pierachille Santus, University of Milan
ClinicalTrials.gov Identifier:
NCT01377051
First received: June 15, 2011
Last updated: September 8, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
COPD
Lung Diseases
Dyspnea
Hypoxemia
Tachycardia
Drug: Indacaterol maleate
Drug: Placebo
Phase 4

Study Type: Interventional
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.

Resource links provided by NLM:


Further study details as provided by University of Milan:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: May 2011
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377051

Locations
Italy
Pneumologia Riabilitativa - Fondazione Maugeri - Istituto Scientifico di Milano - IRCCS
Milano, Italy, 20138
Sponsors and Collaborators
University of Milan
Fondazione Salvatore Maugeri
Investigators
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

No publications provided

Responsible Party: Pierachille Santus, MD, PhD, University of Milan
ClinicalTrials.gov Identifier: NCT01377051     History of Changes
Other Study ID Numbers: 654CEC
Study First Received: June 15, 2011
Last Updated: September 8, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by University of Milan:
COPD
Inspiratory capacity
Residual volume
Total lung resistance
Arterial Oxygen

Additional relevant MeSH terms:
Dyspnea
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Tachycardia
Lung Diseases, Obstructive
Anoxia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Maleic acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014