An interventional study of Placebo and ipratropium bromide in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Zhujiang Hospital. Completed at 1 site in China. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-07-28.
Sponsored by Zhujiang Hospital · Not applicable, Interventional, and Diagnostic
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.
Patients were randomly assigned to one of two intervention groups:
The data were collected in 30 minutes after patients inhaled placebo,in 30 minutes after ipratropium and in 15 minutes after salbutamol.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 22 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
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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.
The medication order: subjects inhaled placebo,ipratropium bromide 80μg, salbutamol 400μg in sequence.
Drug: Placebo · Drug: ipratropium bromide · Drug: salbutamol
The medication order: subjects inhaled placebo, salbutamol 400μg, ipratropium 80μg in sequence.
Drug: Placebo · Drug: ipratropium bromide · Drug: salbutamol
physiological saline
Also known as: Physiological Saline 9 mg/ml
80 µg inhalation once
Also known as: atrovent
400 µg inhalation once
Also known as: Ventolin
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.
Time frame: The groups will be assessed at baseline (time zero) and ten minutes after using each drug.
Respiratory pressure
Respiratory pressure parameters include gastric pressure (Pga), esophageal pressure (Pes), transdiaphragmatic pressure ( Pdi), mouth pressure (Pmo).
Time frame: The groups will be assessed at baseline (time zero) and ten minutes after using each drug.
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).
Time frame: The groups will be assessed at baseline (time zero) and ten minutes after using each drug.
Degree of dyspnea
Difference in the degree of dyspnea can be measured by Borg index.
Time frame: The groups will be assessed at baseline (time zero) and ten minutes after using each drug.
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Zhujiang Hospital