Differences of Small Airways Function Between Chronic Obstructive Pulmonary Disease(COPD) and Asthma-copd Overlap(ACO)

Quality of Life Clinical Trial

Official title:

Differences of Small Airways Function Between Chronic Obstructive Pulmonary Disease(COPD) and Asthma-copd Overlap(ACO)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03563001
• Other study ID #: 2016-HXNK-002
• Status: Recruiting
• Phase: Phase 4
• Start date: June 20, 2018
• Est. completion date: September 2018

Study information

• Verified date: May 2018
• Source: Zhujiang Hospital
• Contact: Huapeng Yu
• Phone: +86 020-61643888
• Email: 359606545[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to research the differences of small airways function between subjects with diagnosis of chronic obstructive pulmonary disease(COPD) and asthma-COPD overlap(ACO).The assessment of quality of life is also carried out through questionnaires.

Description:

This is a randomized,open-label study to research the differences of small airways function between simple chronic obstructive pulmonary disease(COPD) and asthma-COPD overlap(ACO).Assessment of small airways is conducted at baseline,including forced expired volume in one second(FEV1),forced vital capacity(FVC),peak expiratory flow(PEF),maximum expiratory flow rate at 75% of vital capacity(MEF75),maximum expiratory flow rate at 50% of vital capacity(MEF50),maximum expiratory flow rate at 25% of vital capacity(MEF25),impulse oscillometry,diffusion function,residual volume(RV) and total lung capacity(TLC).Budesonide(160ug) and formoterol(4.5ug) bid will be given to both groups(chronic obstructive pulmonary disease and asthma-COPD overlap) for 3 months.Quality of life is assessed through questionnaires including modified Medical Research Council dyspnoea scale(mMRC),St George's Respiratory Questionnaire(SGRQ) and chronic obstructive pulmonary disease assessment test(CAT).All of the patients will have a follow-up visit after 3 months` treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male or female patients 18 to 80 years-old.

• A diagnosis of chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Disease(GOLD 2018) guidelines are recruited to the chronic obstructive pulmonary disease group.A diagnosis of asthma-chronic obstructive pulmonary disease overlap according to Global Initiative for Chronic Obstructive Disease(GOLD 2018),Global Initiative for Asthma(GINA 2018) and Spanish COPD Guidelines(GesEPOC 2017) are recruited to the asthma-chronic obstructive pulmonary disease overlap group.

• Willing and able to provide written informed consent.

• Willing and able to attend all study visits and adhere to all study assessments and procedures.

Exclusion Criteria:

• Severe comorbidities including unstable cardiac or pulmonary disease or any other medical conditions including unstable ischemic heart disease,unstable cardiac arrhythmia or heart failure,life threatening arrhythmias,etc.

• Recent history of chronic obstructive pulmonary disease exacerbation requiring hospitalization or need for increased treatments for chronic obstructive pulmonary disease within 6 weeks.

Related Conditions & MeSH terms

• Asthma
• Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome
• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Quality of Life
• Small Airway Disease

Intervention

Drug:
• Budesonide(160ug) and Formoterol(4.5ug) bid
For both groups of subjects,small airways function of is assessed at baseline.And then budesonide(160ug) and formoterol(4.5ug) bid will be given to the subjects for 3 months.The subjects will have a follow-up visit with the same examinations after 3 months` treatment.

Locations

Country	Name	City	State
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences of maximum expiratory flow rate at 75% of vital capacity(MEF75) between chronic obstructive pulmonary disease and asthma-chronic obstructive pulmonary disease overlap	Maximum expiratory flow rate at 75% of vital capacity(MEF75) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.	3 months
Secondary	Differences of maximum expiratory flow rate at 50% of vital capacity(MEF50) between two groups	Maximum expiratory flow rate at 50% of vital capacity(MEF50) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.	3 months
Secondary	Differences of maximum expiratory flow rate at 25% of vital capacity(MEF25) between two groups	Maximum expiratory flow rate at 25% of vital capacity(MEF25) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.	3 months
Secondary	Differences of impulse oscillometry parameters between two groups	Impulse oscillometry parameters are measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.	3 months
Secondary	Differences of diffusion function between two groups	Diffusion function is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.	3 months
Secondary	Differences of residual volume(RV) between two groups	Residual volume(RV) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.	3 months
Secondary	Differences of total lung capacity(TLC) between two groups	Total lung capacity(TLC) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.	3 months
Secondary	Changes of maximum expiratory flow rate at 75% of vital capacity(MEF75) after 3 months` treatment compared with baseline in both groups	At baseline,maximum expiratory flow rate at 75% of vital capacity(MEF75) is performed in each subject.After 3 months`s treatment of budesonide and formoterol,the test will be performed again.	Change from baseline to 3 months
Secondary	Changes of maximum expiratory flow rate at 50% of vital capacity(MEF50) after 3 months` treatment compared with baseline in both groups	At baseline,maximum expiratory flow rate at 50% of vital capacity(MEF50) is performed in each subject.After 3 months`s treatment of budesonide and formoterol,the test will be performed again.	Change from baseline to 3 months
Secondary	Changes of maximum expiratory flow rate at 25% of vital capacity(MEF25) after 3 months` treatment compared with baseline in both groups	At baseline,maximum expiratory flow rate at 25% of vital capacity(MEF25) is performed in each subject.After 3 months`s treatment of budesonide and formoterol,the test will be performed again.	Change from baseline to 3 months
Secondary	Changes of impulse oscillometry parameters(IOS) after 3 months` treatment compared with baseline in both groups	At baseline,impulse oscillometry is performed in each subject.After 3 months`s treatment of budesonide and formoterol,the test will be performed again.	Change from baseline to 3 months
Secondary	Changes of diffusion function after 3 months` treatment compared with baseline in both groups	At baseline,diffusion function is performed in each subject.After 3 months`s treatment of budesonide and formoterol,the test will be performed again.	Change from baseline to 3 months
Secondary	Changes of total lung capacity(TLC) after 3 months` treatment compared with baseline in both groups	At baseline,total lung capacity(TLC) is performed in each subject.After 3 months`s treatment of budesonide and formoterol,the test will be performed again.	Change from baseline to 3 months
Secondary	Changes of residual volume(RV) after 3 months` treatment compared with baseline in both groups	At baseline,residual volume(RV) is performed in each subject.After 3 months`s treatment of budesonide and formoterol,the test will be performed again.	Change from baseline to 3 months
Secondary	Change of St George's Respiratory Questionnaire(SGRQ) scores after 3 months` treatment compared with baseline	The SGRQ questionnaire is developed to measure the quality of life in patients with chronic airway diseases.Scores range from 0 to 100,higher scores indicates worse respiratory condition.The St George's Respiratory Questionnaire is performed in both groups at baseline.After 3 months`s treatment of budesonide and formoterol,the scores will be measured again.	Change from baseline to 3 months
Secondary	Change of modified Medical Research Council dyspnoea scale(mMRC) scores after 3 months` treatment compared with baseline	The mMRC scale is used to assess the degree of breathlessness.The scores range from 0 to 4,higher scores indicates more serious respiratory condition.The mMRC is performed in both groups at baseline.After 3 months`s treatment of budesonide and formoterol,the scores will be measured again.	Change from baseline to 3 months
Secondary	Change of chronic obstructive pulmonary disease assessment test(CAT) after 3 months` treatment compared with baseline	The CAT test is used to assess the impact of COPD on patients` daily life.The scores range from 0 to 40,higher scores indicates worse respiratory condition.The CAT test is performed in both groups at baseline.After 3 months`s treatment of budesonide and formoterol,the test will be performed again.	Change from baseline to 3 months