A Phase 4 interventional study of Budesonide(160ug) and Formoterol(4.5ug) bid in Pulmonary Disease, Chronic Obstructive, Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome and Small Airway Disease, sponsored by Zhujiang Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-06-27.
Sponsored by Zhujiang Hospital · Phase 4, Interventional, and Treatment
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's planned enrollment of 80 is close to the median of 83 across 2,752 interventional studies indexed under Asthma.
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Exclusion Criteria:
Patients with diagnosis of chronic obstructive pulmonary disease according to Global Initiative for Chronic Obstructive Disease(GOLD 2018) are recruited.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.
Drug: Budesonide(160ug) and Formoterol(4.5ug) bid
Patients with 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.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.
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.
Also known as: SYMBICORT TURBUHALER
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.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: 3 months
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.
Time frame: Change from baseline to 3 months
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.
Time frame: Change from baseline to 3 months
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.
Time frame: Change from baseline to 3 months
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.
Time frame: Change from baseline to 3 months
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.
Time frame: Change from baseline to 3 months
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.
Time frame: Change from baseline to 3 months
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.
Time frame: Change from baseline to 3 months
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.
Time frame: Change from baseline to 3 months
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.
Time frame: Change from baseline to 3 months
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.
Time frame: Change from baseline to 3 months
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Zhujiang Hospital