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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: ipratropium bromide; Drug: Placebo; Drug: salbutamol

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510282
      • Zhujiang Hospital,Southern Medical Universtiy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A; The medication order: subjects inhaled placebo,ipratropium bromide 80μg, salbutamol 400μg in sequence.	Drug: ipratropium bromide; 80 µg inhalation once; Other Names: atrovent; Drug: Placebo; physiological saline; Other Names: Physiological Saline 9 mg/ml; Drug: salbutamol; 400 µg inhalation once; Other Names: Ventolin
EXPERIMENTAL: Group B; The medication order: subjects inhaled placebo, salbutamol 400μg, ipratropium 80μg in sequence.	Drug: ipratropium bromide; 80 µg inhalation once; Other Names: atrovent; Drug: Placebo; physiological saline; Other Names: Physiological Saline 9 mg/ml; Drug: salbutamol; 400 µg inhalation once; Other Names: Ventolin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Collaborators: Guangzhou Panyu Central Hospital
• Investigators: Principal Investigator: Chen Xin, Doctor, Zhujiang Hospital,Southern Medical Unversity

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ACTUAL): May 1, 2015
• Study Completion (ACTUAL): May 1, 2015

Study Registration Dates

• First Submitted: November 10, 2014
• First Submitted That Met QC Criteria: November 17, 2014
• First Posted (ESTIMATE): November 20, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): July 28, 2015
• Last Update Submitted That Met QC Criteria: July 26, 2015
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: COPD, central drive, bronchodilators
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Adrenergic Agonists; Anticonvulsants; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol; Bromides; Ipratropium
• Other Study ID Numbers: CX62782296