NCT02296047

Ventilation-drive Coupling to Evaluate The Efficacy of Inhaled Bronchodilators in Patients With COPD

Ventilation-drive Coupling to Evaluate The Efficacy of Inhaled Bronchodilators in Patients With Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity, mortality and disability throughout the world, leading to a heavy social and economic burden.Bronchodilators, the most commonly used drugs in COPD patients, have been shown to reduce dyspnea, improve exercise tolerance and improve health status. However,conventional lung function parameters such as forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) frequently fail to detect significant functional responses to bronchodilators in patients with chronic airflow obstruction. It is necessary for clinical and scientific reasons to develop a new tool to objectively assess the effect of different treatments including bronchodilator on COPD. Our previous study showed that Ventilation-drive coupling may be more sensitive and accurate to evaluate the efficacy of inhaled bronchodilators in patients with COPD because it could better reflect the pathological and physiological characteristics of COPD. Based on the above conclusion, the present study were performed using the experimental methods of placebo and self-controlled. We aimd to explore the value of ventilation-drive coupling in evaluating the efficacy of bronchodilators on COPD and provide a reasonable basis for the clinical application of this index.

Detailed description

Patients were randomly assigned to one of two intervention groups: 1. Group A: Patients inhaled placebo, ipratropium 80μg, salbutamol 400 μg in sequence; 2. Group B: Patients inhaled placebo, salbutamol 400μg, ipratropium 80 μg in sequence. The data were collected in 30 minutes after patients inhaled placebo,in 30 minutes after ipratropium and in 15 minutes after salbutamol.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	Placebo	physiological saline
DRUG	ipratropium bromide	80 µg inhalation once
DRUG	salbutamol	400 µg inhalation once

Timeline

• Start date: 2014-12-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2014-11-20
• Last updated: 2015-07-28

Locations

1 site across 1 country: China