Impact of Exercise on Lung Function in Patients With Chronic Obstructive Pulmonary Disease
Overview
- Phase
- Phase 4
- Intervention
- Budesonide and formoterol bid
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- Zhujiang Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Changes of forced expired volume in one second(FEV1) after 6-min walk test compared with resting state
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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.
- •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.
Arms & Interventions
Budesonide and formoterol bid
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.
Intervention: Budesonide and formoterol bid
Outcomes
Primary Outcomes
Changes of forced expired volume in one second(FEV1) after 6-min walk test compared with resting state
Time Frame: At resting state and after 6-min walk test
Forced expired volume in one second(FEV1) is measured by Jaeger MasterScreen Pulmonary Function Test System before and after 6-min walk test.
Secondary Outcomes
- Changes of inspiratory capacity(IC) after 6-min walk test compared with resting state(At resting state and after 6-min walk test)
- Changes of blood oxygen saturation after 6-min walk test compared with resting state(At resting state and after 6-min walk test)
- Changes of pulse after 6-min walk test compared with resting state(At resting state and after 6-min walk test)
- Changes of inspiratory capacity(IC) after 3 months' treatment compared with baseline(Change from baseline to 3 months)
- Changes of diffusion function after 3 months' treatment compared with baseline(Change from baseline to 3 months)
- Changes of modified Medical Research Council dyspnoea scale(mMRC) scores after 3 months' treatment compared with baseline(Change from baseline to 3 months)
- Changes of St George's Respiratory Questionnaire(SGRQ) scores after 3 months' treatment compared with baseline(Change from baseline to 3 months)
- Changes of impulse forced oscillometry parameters after 3 months' treatment compared with baseline(Change from baseline to 3 months)
- Changes of clinical chronic obstructive pulmonary questionnaire(CCQ) scores after 3 months' treatment compared with baseline(Change from baseline to 3 months)
- Changes of chronic obstructive pulmonary disease assessment test(CAT) scores after 3 months' treatment compared with baseline(Change from baseline to 3 months)
- The distance and steps of 6-min walk test(Change from baseline to 3 months)
- Changes of forced expired volume in one second(FEV1) after 3 months' treatment compared with baseline(Change from baseline to 3 months)