Effect of indacaterol on lung deflation improves cardiac performance in hyperinflated COPD patients: An interventional, randomized, double-blind clinical trial

Pierachille Santus, Dejan Radovanovic, Silvia Di Marco, Vincenzo Valenti, Rita Raccanelli, Francesco Blasi, Stefano Centanni, Maurizio Bussotti

Research output: Contribution to journalArticle

Abstract

Background: COPD is often associated with cardiovascular comorbidity. Treatment guidelines recommend therapy with bronchodilators as first choice. We investigated the acute effect of single-dose indacaterol on lung hyperinflation in COPD subjects, for the first time evaluating the potential effects on right heart performance. Methods: In this Phase IV, randomized, interventional, double-blind, crossover clinical study, we recruited 40 patients (50-85 years of age) with stable COPD. Patients were treated with 150 μg indacaterol or placebo and after 60 minutes (T60) and 180 minutes (T180) the following tests were performed: trans-thoracic echocardiography (TTE), plethysmography, diffusing capacity of the lung for carbon monoxide, saturation of peripheral oxygen, and visual analog scale dyspnea score. Patients underwent a crossover re-challenge after a further 72 hours of pharmacological washout. All TTE measurements were conducted blindly by the same operator and further interpreted by two different blinded operators. Consensus decisions were taken on every value and parameter. The primary outcome was the effect of the reduction of residual volume and functional residual capacity on right heart systolic and diastolic function indexes evaluated by TTE in patients treated with indacaterol, as compared to placebo. Results: Vital capacity, inspiratory capacity, and forced expiratory volume in 1 second were significantly increased by indacaterol, when compared with placebo, while residual volume, intrathoracic gas volume, and specific airway resistance were significantly reduced in patients treated with indacaterol. Tricuspid annular plane systolic excursion was significantly increased versus placebo, paralleled by an increase of tricuspid E-wave deceleration time. The cardiac frequency was also significantly reduced in indacaterol-treated patients. Conclusion: Indacaterol significantly reduces lung hyperinflation in acute conditions, with a clinically relevant improvement of dyspnea. These modifications are associated with a signifi-cant increase of the right ventricular compliance indexes and may have a role in improving left ventricular preload leading to a reduction in cardiac frequency.

Original languageEnglish
Pages (from-to)1917-1923
Number of pages7
JournalInternational Journal of COPD
Volume10
Issue number1
DOIs
Publication statusPublished - Sep 11 2010

Fingerprint

Chronic Obstructive Pulmonary Disease
Clinical Trials
Lung
Placebos
Echocardiography
Residual Volume
Thorax
Dyspnea
Inspiratory Capacity
Lung Volume Measurements
Functional Residual Capacity
Airway Resistance
Plethysmography
Deceleration
Bronchodilator Agents
Vital Capacity
Forced Expiratory Volume
Carbon Monoxide
indacaterol
Visual Analog Scale

Keywords

  • Bronchodilator
  • Cardiac performance
  • Echocardiography
  • Lung deflation
  • Right ventricular function

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Public Health, Environmental and Occupational Health
  • Health Policy

Cite this

Effect of indacaterol on lung deflation improves cardiac performance in hyperinflated COPD patients : An interventional, randomized, double-blind clinical trial. / Santus, Pierachille; Radovanovic, Dejan; Di Marco, Silvia; Valenti, Vincenzo; Raccanelli, Rita; Blasi, Francesco; Centanni, Stefano; Bussotti, Maurizio.

In: International Journal of COPD, Vol. 10, No. 1, 11.09.2010, p. 1917-1923.

Research output: Contribution to journalArticle

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AU - Radovanovic, Dejan

AU - Di Marco, Silvia

AU - Valenti, Vincenzo

AU - Raccanelli, Rita

AU - Blasi, Francesco

AU - Centanni, Stefano

AU - Bussotti, Maurizio

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AB - Background: COPD is often associated with cardiovascular comorbidity. Treatment guidelines recommend therapy with bronchodilators as first choice. We investigated the acute effect of single-dose indacaterol on lung hyperinflation in COPD subjects, for the first time evaluating the potential effects on right heart performance. Methods: In this Phase IV, randomized, interventional, double-blind, crossover clinical study, we recruited 40 patients (50-85 years of age) with stable COPD. Patients were treated with 150 μg indacaterol or placebo and after 60 minutes (T60) and 180 minutes (T180) the following tests were performed: trans-thoracic echocardiography (TTE), plethysmography, diffusing capacity of the lung for carbon monoxide, saturation of peripheral oxygen, and visual analog scale dyspnea score. Patients underwent a crossover re-challenge after a further 72 hours of pharmacological washout. All TTE measurements were conducted blindly by the same operator and further interpreted by two different blinded operators. Consensus decisions were taken on every value and parameter. The primary outcome was the effect of the reduction of residual volume and functional residual capacity on right heart systolic and diastolic function indexes evaluated by TTE in patients treated with indacaterol, as compared to placebo. Results: Vital capacity, inspiratory capacity, and forced expiratory volume in 1 second were significantly increased by indacaterol, when compared with placebo, while residual volume, intrathoracic gas volume, and specific airway resistance were significantly reduced in patients treated with indacaterol. Tricuspid annular plane systolic excursion was significantly increased versus placebo, paralleled by an increase of tricuspid E-wave deceleration time. The cardiac frequency was also significantly reduced in indacaterol-treated patients. Conclusion: Indacaterol significantly reduces lung hyperinflation in acute conditions, with a clinically relevant improvement of dyspnea. These modifications are associated with a signifi-cant increase of the right ventricular compliance indexes and may have a role in improving left ventricular preload leading to a reduction in cardiac frequency.

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