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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide and formoterol bid | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide and formoterol bid | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes 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. | At resting state and after 6-min walk test |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At resting state and after 6-min walk test |
| Changes of blood oxygen saturation after 6-min walk test compared with resting state |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huapeng Yu | Contact | +86 020-61643888 | 359606545@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Huapeng Yu | Southern Medical University, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhujiang Hospital of Southern Medical University | Recruiting | Guangzhou | Guangdong | China |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 9, 2021 | |
| Reset | Sep 2, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 9, 2021 | Sep 2, 2021 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009043 | Motor Activity |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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There is only one group.Patients with diagnosis of Chronic Obstructive Pulmonary Disease are recruited.Subjects will be examined at baseline and after 3 months' treatment of budesonide and formoterol.
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Blood oxygen saturation is measured before and after 6-min walk test. |
| 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. | 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. | 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. | Change from baseline to 3 months |
| 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. | 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. | 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. | 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. | 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. | 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. | Change from baseline to 3 months |
| The distance and steps of 6-min walk test | Both the the distance and steps are measured | Change from baseline to 3 months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D012120 | Respiration Disorders |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |