Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
COPD, central drive, bronchodilators
Brief 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.
Interventions
DRUGPlacebo
physiological saline
DRUGipratropium bromide
80 µg inhalation once
DRUGsalbutamol
400 µg inhalation once
Sponsors
Guangzhou Panyu Central Hospital
Zhujiang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Patients aged 40-70 years old; Patients with pulmonary function test of FEV1/FVC \< 70% and FEV1%pred \< 50%; Patients in a clinically stable state; Patients who signed informed consent.
Exclusion criteria
Patients with signs of an airway infection; Patients with an acute exacerbation during the previous 4 weeks; Patients with giant bulla(≥3cm in diameter); Patients with recent upper abdominal surgery; Patients with one or more of the following diseases: esophageal cancer, reflux esophagitis, severe obstructive sleep apnea (apnea hypopnea index\>15/hr), neuromuscular disease, or significant heart failure; Patients with poor compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diaphragmatic function | The groups will be assessed at baseline (time zero) and ten minutes after using each drug. | Diaphragmatic function can be assessed by diaphragm electromyogram (EMGdi), which reflect the physiological activity of the diaphragm and indicate functional status of the central drive. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory pressure | The groups will be assessed at baseline (time zero) and ten minutes after using each drug. | Respiratory pressure parameters include gastric pressure (Pga), esophageal pressure (Pes), transdiaphragmatic pressure ( Pdi), mouth pressure (Pmo). |
| Respiratory volume | The groups will be assessed at baseline (time zero) and ten minutes after using each drug. | Respiratory volume is associated with Flow, Inspiratory capacity (IC), tidal volume (VT), respiratory rate (RR), inspiratory time (Ti),expiratory time (Te), minute ventilation (VE). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Degree of dyspnea | The groups will be assessed at baseline (time zero) and ten minutes after using each drug. | Difference in the degree of dyspnea can be measured by Borg index. |
Countries
China
Outcome results
None listed