Small Airways Evaluation and Treatment

August 17, 2015 updated by: Zhujiang Hospital

Evaluation and Treatment of Small Airways in COPD

Chronic obstructive pulmonary disease (COPD) is a common disease , and characterized by progressive development of airflow limitation. Small airway disease (obstructive bronchitis) and lung parenchyma damage (emphysema) are the main mechanisms of chronic airflow limitation. Research shows that small airway resistance increased by 4-40 times in COPD patients, and become the main part of the airflow obstruction. Impulse oscillation system (IOS) is able to measure the total airway resistance, the central airway resistance and the peripheral airway resistance, which is now widely used to assess small airway function in COPD patients. While High resolution CT (HRCT) is easy to operate and its images are intuitive. Meanwhile it can measure the proportion of emphysema, the airway diameter and the thickness of airway wall. Both of these two tests have great significance in small airway evaluation. Chronic obstructive pulmonary disease with acute exacerbation (AECOPD) is an acute onset process, which is characterized by the aggravation of respiratory symptoms and deterioration of pulmonary function. However, the structural and functional changes of small airway in AECOPD are not clear. Inhalation drugs are the main treatment for stable COPD , and inhaled corticosteroid（ICS）+long-acting beta2-agonist（LABA） are used to treat patients with severe and severe airflow limitation. The particles in traditional inhalation drugs are larger and mainly deposited in large airways, and their effects on small airway function are relatively small.

The objectives of the investigators study are COPD patients. The study is divided into two parts, that is the part of AECOPD patients and the part of stable patients . Patients with AECOPD are arranged to take HRCT and IOS test to assess the small airway changes.Patients with stable COPD are randomized to take either beclomethasone / formoterol (particle diameter for 1.4-1.5um) or budesonide / formoterol (3.2um) for three months. The structure and function changes of small airway in different stage will be evaluated and the efficacy of these two drugs is to be compared. This study is expected to highlight the investigators understanding on the role of small airways in COPD, and provide a guideline to clinical standardized treatment as well as evaluation of patients' conditions.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The COPD patients in the investigators hospital are selected to participate in the investigators study, and strict inclusion and exclusion criteria are to be complied with. All the subjects will be told the details of the study and sign the informed consent before inclusion.HRCT will be used to evaluate the structure of small airway by measuring the thickness of the third stage branches of apical segmental bronchus in the right upper lobe (WT). R5-R20 measured by IOS will be used to assess small airway resistance.

The study is divided into two parts, that is the part of AECOPD patients and the part of stable patients . Both of them have three steps .

Part 1. AECOPD patients:

  • Subjects screening : To inquire the history of the disease and to take the IOS and Bronchial dilation test.
  • Baseline data collection：patients will be arranged to complete a series of questionnaires, as well as HRCT, IOS, pulmonary function test and 6 minute walk test.
  • Test stage：During their hospital stay, the patients are to be treated with oxygen inhalation and different kinds of drugs, and the patients will followed up for three weeks after discharge. Completing the examinations and questionnaires at each time visit ,and another CT scan at the last visit.

Part 2. Stable COPD patients:

  • Subjects screening : To inquire the history of the disease and to take the IOS and Bronchial dilation test.
  • Baseline data collection：In the two-week washout period，patients are only allowed take salmeterol/fluticasone 50:250ug 2 times daily, and stop the use of other inhalation drugs and oral glucocorticoid. At the end of this period, complete a series of questionnaires, as well as HRCT, IOS, pulmonary function test and 6 minute walk test.
  • Test stage： patients are randomized to take either beclomethasone / formoterol (100:6ug 2inhalations twice daily ) or budesonide / formoterol (160:4.5ug 2inhalations twice daily) for three months.Completing the examinations and questionnaires at the end of each month, another CT scan at the last visit.

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510280
        • Recruiting
        • Zhujiang Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of chronic obstructive pulmonary disease;
  • More than 40 years;

Exclusion Criteria:

  • asthma , or combined with bronchiectasia，pneumonia in the right upper lobe;
  • Malignant tumor in the lung or other parts of the body;
  • Uncontrolled hypertension (systolic blood pressure >200 mmHg, diastolic blood pressure >100 mmHg);
  • Severe cardiac insufficiency, arrhythmia;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: beclomethasone / formoterol
beclomethasone 100ug and formoterol 6ug , 2 inhalations, twice daily ,for three months
Drug: formoterol
Drug: beclomethasone
Other Names:
  • Beclomethasone Dipropionate,BDP
Active Comparator: budesonide / formoterol
budesonide 160ug and formoterol 4.5ug, 2 inhalations ,twice daily ,for three month
Drug: formoterol
Drug: budesonide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
R5-R20 measured by IOS
Time Frame: three month
Change of small airway resistance (R5-R20)measured by IOS at three months
three month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
forced expiratory volume at one second（FEV1）
Time Frame: three month
change of forced expiratory volume at one second（FEV1） measured by pulmonary function test（PFT）at three months
three month
Score of symptoms using the St. George respiratory questionnaire
Time Frame: three month
The St. George respiratory questionnaire
three month
Score of symptoms using modified Medical Research Council Dyspnoea Scale(mMRC)
Time Frame: three month
modified Medical Research Council Dyspnoea Scale(mMRC)
three month
Score of symptoms
Time Frame: three month
CAT
three month
Change of wall thickness（WT）
Time Frame: three month
change of thickness of the third stage branches of apical segmental bronchus in the right upper lobe (WT) in three months
three month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Investigators

  • Study Chair: Huizhen Fan, Doctor, Zhujiang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

August 17, 2015

First Posted (Estimate)

August 18, 2015

Study Record Updates

Last Update Posted (Estimate)

August 18, 2015

Last Update Submitted That Met QC Criteria

August 17, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SACOPD2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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