Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
Ventilation-drive Coupling to Evaluate The Efficacy of Inhaled Bronchodilators in Patients With Chronic Obstructive Pulmonary Disease
Verified date | November 2014 |
Source | Zhujiang Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 70 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
China | Zhujiang Hospital,Southern Medical Universtiy | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Zhujiang Hospital | Guangzhou Panyu Central Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Degree of dyspnea | Difference in the degree of dyspnea can be measured by Borg index. | The groups will be assessed at baseline (time zero) and ten minutes after using each drug. | No |
Primary | Diaphragmatic function | 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. | The groups will be assessed at baseline (time zero) and ten minutes after using each drug. | No |
Secondary | Respiratory pressure | Respiratory pressure parameters include gastric pressure (Pga), esophageal pressure (Pes), transdiaphragmatic pressure ( Pdi), mouth pressure (Pmo). | The groups will be assessed at baseline (time zero) and ten minutes after using each drug. | No |
Secondary | Respiratory volume | Respiratory volume is associated with Flow, Inspiratory capacity (IC), tidal volume (VT), respiratory rate (RR), inspiratory time (Ti),expiratory time (Te), minute ventilation (VE). | The groups will be assessed at baseline (time zero) and ten minutes after using each drug. | No |
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