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

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Exercise, Lung Function Decreased

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Budesonide and formoterol bid

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary Disease, Chronic Obstructive, exercise, lung function, quality of life

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Zhujiang Hospital of Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Budesonide and formoterol bid

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Changes of pulse after 6-min walk test compared with resting state

Pulse is measured before 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.

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.

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.

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.

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.

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.

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.

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.

The distance and steps of 6-min walk test

Both the the distance and steps are measured

Full Information

NCT ID

NCT03551197

First Posted

May 9, 2018

Last Updated

June 18, 2018

Sponsor

Zhujiang Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03551197

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Unknown status

Study Start Date

June 13, 2018 (Actual)

Primary Completion Date

September 2018 (Anticipated)

Study Completion Date

September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zhujiang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Pulmonary Disease, Chronic Obstructive, exercise, lung function, quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Budesonide and formoterol bid

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Budesonide and formoterol bid

Other Intervention Name(s)

SYMBICORT TURBUHALER

Intervention Description

Primary Outcome Measure Information:

Title

Changes of forced expired volume in one second(FEV1) after 6-min walk test compared with resting state

Description

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

Secondary Outcome Measure Information:

Title

Changes of inspiratory capacity(IC) after 6-min walk test compared with resting state

Description

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

Title

Changes of blood oxygen saturation after 6-min walk test compared with resting state

Description

Blood oxygen saturation is measured before and after 6-min walk test.

Time Frame

At resting state and after 6-min walk test

Title

Changes of pulse after 6-min walk test compared with resting state

Description

Pulse is measured before and after 6-min walk test.

Time Frame

At resting state and after 6-min walk test

Title

Changes of forced expired volume in one second(FEV1) after 3 months' treatment compared with baseline

Description

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