Small Airways Evaluation and Treatment

NCT02526758 | Unknown Phase 4

• 1 other identifier: SACOPD2015
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Disease，Chronic Obstructive;

Keywords

Pulmonary disease; chronic obstructive; small airway

Outcome Measures

Primary Outcomes (1)

• R5-R20 measured by IOS

  Change of small airway resistance (R5-R20)measured by IOS at three months

  three month

Secondary Outcomes (5)

• forced expiratory volume at one second（FEV1）

  three month

• Score of symptoms using the St. George respiratory questionnaire

  three month

• Score of symptoms using modified Medical Research Council Dyspnoea Scale(mMRC)

  three month

• Score of symptoms

  three month

• Change of wall thickness（WT）

  three month

Study Arms (2)

beclomethasone / formoterol

EXPERIMENTAL

beclomethasone 100ug and formoterol 6ug , 2 inhalations, twice daily ,for three months

Drug: beclomethasone; Drug: formoterol

budesonide / formoterol

ACTIVE COMPARATOR

budesonide 160ug and formoterol 4.5ug, 2 inhalations ,twice daily ,for three month

Drug: formoterol; Drug: budesonide

Interventions

beclomethasone DRUG

Also known as: Beclomethasone Dipropionate,BDP

beclomethasone / formoterol

formoterol DRUG

beclomethasone / formoterol; budesonide / formoterol

budesonide DRUG

budesonide / formoterol

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital

Guangzhou, Guangdong, 510280, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases

Interventions

Beclomethasone; Formoterol Fumarate; Budesonide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Pregnenediones; Pregnenes

Study Officials

• Huizhen Fan, Doctor

  Zhujiang Hospital

  STUDY CHAIR

Central Study Contacts

Shuhan Wu, Master

CONTACT

13268268627; 664397041@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 18, 2015
• Study Start: April 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 18, 2015

Record last verified: 2015-08

Locations

CN (1)