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

NCT02296047 | Completed DMC

• 1 other identifier: CX62782296
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD, central drive, bronchodilators

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Respiratory pressure

  The groups will be assessed at baseline (time zero) and ten minutes after using each drug.

• Respiratory volume

  The groups will be assessed at baseline (time zero) and ten minutes after using each drug.

Other Outcomes (1)

• Degree of dyspnea

  The groups will be assessed at baseline (time zero) and ten minutes after using each drug.

Study Arms (2)

Group A

EXPERIMENTAL

The medication order: subjects inhaled placebo,ipratropium bromide 80μg, salbutamol 400μg in sequence.

Drug: Placebo; Drug: ipratropium bromide; Drug: salbutamol

Group B

EXPERIMENTAL

The medication order: subjects inhaled placebo, salbutamol 400μg, ipratropium 80μg in sequence.

Drug: Placebo; Drug: ipratropium bromide; Drug: salbutamol

Interventions

Placebo DRUG

physiological saline

Also known as: Physiological Saline 9 mg/ml

Group A; Group B

ipratropium bromide DRUG

80 µg inhalation once

Also known as: atrovent

Group A; Group B

salbutamol DRUG

400 µg inhalation once

Also known as: Ventolin

Group A; Group B

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead
• Guangzhou Panyu Central Hospital: collaborator

Study Sites (1)

Zhujiang Hospital,Southern Medical Universtiy

Guangzhou, Guangdong, 510282, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ipratropium; Albuterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines

Study Officials

• Chen Xin, Doctor

  Zhujiang Hospital,Southern Medical Unversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2014
• First Posted: November 20, 2014
• Study Start: December 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 28, 2015

Record last verified: 2014-11

Locations

CN (1)