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OpenTrials
Completed

NCT Number: NCT01377051

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.

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Key information

Conditions

COPD Arrhythmias, Cardiac Cardiac Conduction System Disease Cardiovascular Diseases Chronic Disease Disease Attributes Dyspnea Heart Diseases Hypoxemia Hypoxia Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Tachycardia

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Milan, 20138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indacaterol maleate

Drug

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

Other names: Onbrez, Hirobriz, Onbrize, Oslif Breezehaler, Arcapta

Placebo

Drug

Dry powered, same to study drug, only one inhalation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Milan

Other

Collaborators

  • Fondazione Salvatore Maugeri

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 20, 2011
Registry last updated
Oct 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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