Change of Lung Function After Exercise in Patients With Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Exercise on Lung Function in Patients With Chronic Obstructive Pulmonary Disease

Conditions
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Exercise, Lung Function Decreased, Quality of Life, Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Drug: Budesonide and formoterol bid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients 18 to 80 years-old, inclusive. A clinical diagnosis of chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Disease(GOLD 2018) guidelines. Post bronchodilator (following inhalation of salbutamol) forced expired volume in one second(FEV1)/forced vital capacity(FVC) ratio ≤0.70. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Budesonide and formoterol bid<br>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. | Drug: Budesonide and formoterol bid<br>* 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.<br>* Other names: SYMBICORT TURBUHALER;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulmonary Disease, Chronic Obstructive, exercise, lung function, quality of life