The purpose of this study is to evaluate the changes of lung function before and after the exercise in patients with chronic obstructive pulmonary disease.The assessment of quality of life is also carried out through questionnaires.
This is a randomized,open-label study to research the changes of lung function before and after exercise in patients with chronic obstructive pulmonary disease .At baseline,lung function test,blood oxygen saturation and pulse are measured before and after 6-min walk test for each subject.Quality of life is assessed through questionnaires including modified Medical Research Council dyspnoea scale(mMRC),St George's Respiratory Questionnaire(SGRQ),Clinical Chronic Obstructive Pulmonary Questionnaire(CCQ) and chronic obstructive pulmonary assessment test(CAT).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 all the examinations mentioned above after 3 months' treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
At baseline,lung function test,blood oxygen saturation and pulse are measured before and after 6-min walk test for each subject.Quality of life is assessed through questionnaires including modified Medical Research Council dyspnoea scale(mMRC),St George's Respiratory Questionnaire(SGRQ),clinical chronic obstructive pulmonary questionnaire(CCQ) and chronic obstructive pulmonary disease assessment test(CAT).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 all the examinations mentioned above after 3 months' treatment.
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGChanges of forced expired volume in one second(FEV1) after 6-min walk test compared with resting state
Forced expired volume in one second(FEV1) is measured by Jaeger MasterScreen Pulmonary Function Test System before and after 6-min walk test.
Time frame: At resting state and after 6-min walk test
Changes of inspiratory capacity(IC) after 6-min walk test compared with resting state
Inspiratory capacity(IC) is measured by Jaeger MasterScreen Pulmonary Function Test System before and after 6-min walk test.
Time frame: At resting state and after 6-min walk test
Changes of blood oxygen saturation after 6-min walk test compared with resting state
Blood oxygen saturation is measured before and after 6-min walk test.
Time frame: At resting state and after 6-min walk test
Changes of pulse after 6-min walk test compared with resting state
Pulse is measured before and after 6-min walk test.
Time frame: At resting state and after 6-min walk test
Changes of forced expired volume in one second(FEV1) after 3 months' treatment compared with baseline
At baseline,forced expired volume in one second(FEV1) is measured.After 3 months's treatment of budesonide and formoterol,FEV1 will be measured again.
Time frame: Change from baseline to 3 months
Changes of inspiratory capacity(IC) after 3 months' treatment compared with baseline
At baseline,inspiratory capacity(IC) is measured.After 3 months's treatment of budesonide and formoterol,IC will be measured again.
Time frame: Change from baseline to 3 months
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Changes of diffusion function after 3 months' treatment compared with baseline
At baseline,diffusion function is measured.After 3 months's treatment of budesonide and formoterol,diffusion function will be measured again.
Time frame: Change from baseline to 3 months
Changes of impulse forced oscillometry parameters after 3 months' treatment compared with baseline
At baseline,impulse forced oscillometry parameters are measured.After 3 months's treatment of budesonide and formoterol,impulse forced oscillometry parameters will be measured again.
Time frame: Change from baseline to 3 months
Changes of modified Medical Research Council dyspnoea scale(mMRC) scores after 3 months' treatment compared with baseline
At baseline,quality of life is assessed by modified Medical Research Council dyspnoea scale(mMRC).After 3 months's treatment of budesonide and formoterol,the mMRC scores will be measured again.
Time frame: Change from baseline to 3 months
Changes of St George's Respiratory Questionnaire(SGRQ) scores after 3 months' treatment compared with baseline
At baseline,quality of life is assessed by St George's Respiratory Questionnaire(SGRQ).After 3 months's treatment of budesonide and formoterol,the SGRQ scores will be measured again.
Time frame: Change from baseline to 3 months
Changes of clinical chronic obstructive pulmonary questionnaire(CCQ) scores after 3 months' treatment compared with baseline
At baseline,quality of life is assessed by clinical chronic obstructive pulmonary disease questionnaire(CCQ).After 3 months's treatment of budesonide and formoterol,the scores will be measured again.
Time frame: Change from baseline to 3 months
Changes of chronic obstructive pulmonary disease assessment test(CAT) scores after 3 months' treatment compared with baseline
At baseline,quality of life is assessed by chronic obstructive pulmonary disease assessment test(CAT).After 3 months's treatment of budesonide and formoterol,the test will be performed again.
Time frame: Change from baseline to 3 months
The distance and steps of 6-min walk test
Both the the distance and steps are measured
Time frame: Change from baseline to 3 months