Pulmonary Disease, Chronic ObstructivePhase 4NCT03551197
Change of Lung Function After Exercise in Patients With Chronic Obstructive Pulmonary Disease
A Phase 4 study testing Budesonide and formoterol bid in people with Pulmonary Disease, Chronic Obstructive and Exercise, run by Zhujiang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Exercise, Lung Function Decreased
- What is being tested?
- Budesonide and formoterol bid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2018to Sep 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
Huapeng Yu, +86 020-61643888, 359606545@qq.com
About this study
Official title: Impact of Exercise on Lung Function in Patients With Chronic Obstructive Pulmonary Disease
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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Exercise, Lung Function Decreased, Quality of Life
- Being tested
- Budesonide and formoterol bid
- Keywords
- Pulmonary Disease, Chronic Obstructive, exercise, lung function, quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide and formoterol bidDrug
Also called SYMBICORT TURBUHALER
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Budesonide and formoterol bid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At resting state and after 6-min walk test
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to 3 months
The distance and steps of 6-min walk test
Both the the distance and steps are measured
Measured: Change from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start13 Jun 2018
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huapeng Yu, Principal investigator, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551197
- Sponsor's protocol ID
- 2018-HXNK-001
- Status last verified
- May 2018
- First submitted
- 9 May 2018
- Last updated
- 20 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exercise on Lung Function in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03551197
- Acronym / sponsor ID
- 2018-HXNK-001
- Conditions
- Pulmonary Disease, Chronic Obstructive, Exercise, Lung Function Decreased, Quality of Life
- Keywords
- Pulmonary Disease, Chronic Obstructive, exercise, lung function, quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 13 Jun 2018 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 11 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Budesonide and formoterol bid | Experimental | Drug: Budesonide and formoterol bidAt 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide and formoterol bidAlso: SYMBICORT TURBUHALERAt 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 |
Primary outcome
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.
12 secondary outcomes
Changes of inspiratory capacity(IC) after 6-min walk test compared with resting state
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
Time frame: At resting state and after 6-min walk test
Changes of pulse after 6-min walk test compared with resting state
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
Time frame: Change from baseline to 3 months
Changes of inspiratory capacity(IC) after 3 months' treatment compared with baseline
Time frame: Change from baseline to 3 months
Changes of diffusion function after 3 months' treatment compared with baseline
Time frame: Change from baseline to 3 months
Changes of impulse forced oscillometry parameters after 3 months' treatment compared with baseline
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
Time frame: Change from baseline to 3 months
Changes of St George's Respiratory Questionnaire(SGRQ) scores after 3 months' treatment compared with baseline
Time frame: Change from baseline to 3 months
Changes of clinical chronic obstructive pulmonary questionnaire(CCQ) scores after 3 months' treatment compared with baseline
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
Time frame: Change from baseline to 3 months
The distance and steps of 6-min walk test
Time frame: Change from baseline to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huapeng Yu principal investigator
Southern Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Budesonide and formoterol bid in people with Pulmonary Disease, Chronic Obstructive and Exercise, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huapeng Yu (+86 020-61643888, 359606545@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.