Quality of Life Clinical Trial
Official title:
Differences of Small Airways Function Between Chronic Obstructive Pulmonary Disease(COPD) and Asthma-copd Overlap(ACO)
Verified date | May 2018 |
Source | Zhujiang Hospital |
Contact | Huapeng Yu |
Phone | +86 020-61643888 |
359606545[@]qq.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Zhujiang Hospital of Southern Medical University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Zhujiang Hospital |
China,
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 |
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