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Small Airways Evaluation and Treatment

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2015 by Zhujiang Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02526758
First Posted: August 18, 2015
Last Update Posted: August 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zhujiang Hospital
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease,Chronic Obstructive; Drug: beclomethasone Drug: formoterol Drug: budesonide Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation and Treatment of Small Airways in COPD

Resource links provided by NLM:


Further study details as provided by Zhujiang Hospital:

Primary Outcome Measures:
  • R5-R20 measured by IOS [ Time Frame: three month ]
    Change of small airway resistance (R5-R20)measured by IOS at three months


Secondary Outcome Measures:
  • 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

  • Score of symptoms using the St. George respiratory questionnaire [ Time Frame: three month ]
    The St. George respiratory questionnaire

  • Score of symptoms using modified Medical Research Council Dyspnoea Scale(mMRC) [ Time Frame: three month ]
    modified Medical Research Council Dyspnoea Scale(mMRC)

  • Score of symptoms [ Time Frame: three month ]
    CAT

  • 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


Estimated Enrollment: 90
Study Start Date: April 2015
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: beclomethasone / formoterol
beclomethasone 100ug and formoterol 6ug , 2 inhalations, twice daily ,for three months
Drug: beclomethasone
Other Name: Beclomethasone Dipropionate,BDP
Drug: formoterol
Active Comparator: budesonide / formoterol
budesonide 160ug and formoterol 4.5ug, 2 inhalations ,twice daily ,for three month
Drug: formoterol Drug: budesonide

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02526758


Contacts
Contact: Shuhan Wu, Master 13268268627 664397041@qq.com

Locations
China, Guangdong
Zhujiang Hospital Recruiting
Guangzhou, Guangdong, China, 510280
Contact: Shuhan Wu, Master    13268268627    664397041@qq.com   
Sponsors and Collaborators
Zhujiang Hospital
Investigators
Study Chair: Huizhen Fan, Doctor Zhujiang Hospital
  More Information

Responsible Party: Zhujiang Hospital
ClinicalTrials.gov Identifier: NCT02526758     History of Changes
Other Study ID Numbers: SACOPD2015
First Submitted: August 10, 2015
First Posted: August 18, 2015
Last Update Posted: August 18, 2015
Last Verified: August 2015

Keywords provided by Zhujiang Hospital:
Pulmonary disease
chronic obstructive
small airway

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Formoterol Fumarate
Budesonide
Beclomethasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists