Pulmonary Disease, Chronic ObstructivePhase 4NCT03563001
Differences of Small Airways Function Between Chronic Obstructive Pulmonary Disease(COPD) and Asthma-copd Overlap(ACO)
A Phase 4 study testing Budesonide(160ug) and Formoterol(4.5ug) bid in people with Pulmonary Disease, Chronic Obstructive and Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome, run by Zhujiang Hospital at 1 site in China.
Trial summary
The purpose of this study is to research the differences of small airways function between subjects with diagnosis of chronic obstructive pulmonary disease(COPD) and asthma-COPD overlap(ACO).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, Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome, Small Airway Disease
- What is being tested?
- Budesonide(160ug) and Formoterol(4.5ug) bid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 20 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.
- A diagnosis of chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Disease(GOLD 2018) guidelines are recruited to the chronic obstructive pulmonary disease group.A diagnosis of asthma-chronic obstructive pulmonary disease overlap according to Global Initiative for Chronic Obstructive Disease(GOLD 2018),Global Initiative for Asthma(GINA 2018) and Spanish COPD Guidelines(GesEPOC 2017) are recruited to the asthma-chronic obstructive pulmonary disease overlap group.
- 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
The purpose of this study is to research the differences of small airways function between subjects with diagnosis of chronic obstructive pulmonary disease(COPD) and asthma-COPD overlap(ACO).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 differences of small airways function between simple chronic obstructive pulmonary disease(COPD) and asthma-COPD overlap(ACO).Assessment of small airways is conducted at baseline,including forced expired volume in one second(FEV1),forced vital capacity(FVC),peak expiratory flow(PEF),maximum expiratory flow rate at 75% of vital capacity(MEF75),maximum expiratory flow rate at 50% of vital capacity(MEF50),maximum expiratory flow rate at 25% of vital capacity(MEF25),impulse oscillometry,diffusion function,residual volume(RV) and total lung capacity(TLC).Budesonide(160ug) and formoterol(4.5ug) bid will be given to both groups(chronic obstructive pulmonary disease and asthma-COPD overlap) for 3 months.Quality of life is assessed through questionnaires including modified Medical Research Council dyspnoea scale(mMRC),St George's Respiratory Questionnaire(SGRQ) and chronic obstructive pulmonary disease assessment test(CAT).All of the patients will have a follow-up visit after 3 months' treatment.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome, Small Airway Disease, Quality of Life
- Being tested
- Budesonide(160ug) and Formoterol(4.5ug) bid
- Keywords
- chronic obstructive pulmonary disease, asthma-chronic obstructive pulmonary disease overlap, small airway, quality of life
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide(160ug) and Formoterol(4.5ug) bidDrug
Also called SYMBICORT TURBUHALER
For both groups of subjects,small airways function of is assessed at baseline.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 the same examinations after 3 months' treatment.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Obstructive Pulmonary Disease Group | Experimental | Patients with diagnosis of chronic obstructive pulmonary disease according to Global Initiative for Chronic Obstructive Disease(GOLD 2018) are recruited.Small airways function of is assessed at baseline.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 the same examinations after 3 months' treatment. Receives: Drug: Budesonide(160ug) and Formoterol(4.5ug) bid |
| Asthma-Chronic Obstructive Pulmonary Disease Overlap Group | Experimental | Patients with diagnosis of asthma-chronic obstructive pulmonary disease overlap according to Global Initiative for Chronic Obstructive Disease(GOLD 2018),Global Initiative for Asthma(GINA 2018) and Spanish COPD Guidelines(GesEPOC 2017) are recruited.Small airways function of is assessed at baseline.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 the same examinations after 3 months' treatment. Receives: Drug: Budesonide(160ug) and Formoterol(4.5ug) bid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences of maximum expiratory flow rate at 75% of vital capacity(MEF75) between chronic obstructive pulmonary disease and asthma-chronic obstructive pulmonary disease overlap
Maximum expiratory flow rate at 75% of vital capacity(MEF75) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.
Measured: 3 months
Secondary outcomes (16)
Differences of maximum expiratory flow rate at 50% of vital capacity(MEF50) between two groups
Maximum expiratory flow rate at 50% of vital capacity(MEF50) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.
Measured: 3 months
Differences of maximum expiratory flow rate at 25% of vital capacity(MEF25) between two groups
Maximum expiratory flow rate at 25% of vital capacity(MEF25) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.
Measured: 3 months
Differences of impulse oscillometry parameters between two groups
Impulse oscillometry parameters are measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.
Measured: 3 months
Differences of diffusion function between two groups
Diffusion function is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.
Measured: 3 months
Differences of residual volume(RV) between two groups
Residual volume(RV) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.
Measured: 3 months
Differences of total lung capacity(TLC) between two groups
Total lung capacity(TLC) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.
Measured: 3 months
Changes of maximum expiratory flow rate at 75% of vital capacity(MEF75) after 3 months' treatment compared with baseline in both groups
At baseline,maximum expiratory flow rate at 75% of vital capacity(MEF75) is performed in each subject.After 3 months's treatment of budesonide and formoterol,the test will be performed again.
Measured: Change from baseline to 3 months
Changes of maximum expiratory flow rate at 50% of vital capacity(MEF50) after 3 months' treatment compared with baseline in both groups
At baseline,maximum expiratory flow rate at 50% of vital capacity(MEF50) is performed in each subject.After 3 months's treatment of budesonide and formoterol,the test will be performed again.
Measured: Change from baseline to 3 months
Changes of maximum expiratory flow rate at 25% of vital capacity(MEF25) after 3 months' treatment compared with baseline in both groups
At baseline,maximum expiratory flow rate at 25% of vital capacity(MEF25) is performed in each subject.After 3 months's treatment of budesonide and formoterol,the test will be performed again.
Measured: Change from baseline to 3 months
Changes of impulse oscillometry parameters(IOS) after 3 months' treatment compared with baseline in both groups
At baseline,impulse oscillometry is performed in each subject.After 3 months's treatment of budesonide and formoterol,the test will be performed again.
Measured: Change from baseline to 3 months
Changes of diffusion function after 3 months' treatment compared with baseline in both groups
At baseline,diffusion function is performed in each subject.After 3 months's treatment of budesonide and formoterol,the test will be performed again.
Measured: Change from baseline to 3 months
Changes of total lung capacity(TLC) after 3 months' treatment compared with baseline in both groups
At baseline,total lung capacity(TLC) is performed in each subject.After 3 months's treatment of budesonide and formoterol,the test will be performed again.
Measured: Change from baseline to 3 months
Changes of residual volume(RV) after 3 months' treatment compared with baseline in both groups
At baseline,residual volume(RV) is performed in each subject.After 3 months's treatment of budesonide and formoterol,the test will be performed again.
Measured: Change from baseline to 3 months
Change of St George's Respiratory Questionnaire(SGRQ) scores after 3 months' treatment compared with baseline
The SGRQ questionnaire is developed to measure the quality of life in patients with chronic airway diseases.Scores range from 0 to 100,higher scores indicates worse respiratory condition.The St George's Respiratory Questionnaire is performed in both groups at baseline.After 3 months's treatment of budesonide and formoterol,the scores will be measured again.
Measured: Change from baseline to 3 months
Change of modified Medical Research Council dyspnoea scale(mMRC) scores after 3 months' treatment compared with baseline
The mMRC scale is used to assess the degree of breathlessness.The scores range from 0 to 4,higher scores indicates more serious respiratory condition.The mMRC is performed in both groups at baseline.After 3 months's treatment of budesonide and formoterol,the scores will be measured again.
Measured: Change from baseline to 3 months
Change of chronic obstructive pulmonary disease assessment test(CAT) after 3 months' treatment compared with baseline
The CAT test is used to assess the impact of COPD on patients' daily life.The scores range from 0 to 40,higher scores indicates worse respiratory condition.The CAT test is performed in both groups at baseline.After 3 months's treatment of budesonide and formoterol,the test will be performed again.
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 posted20 Jun 2018
- Study start20 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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with diagnosis of simple chronic obstructive pulmonary disease(COPD) and asthma-chronic obstructive pulmonary disease overlap(ACO) are recruited.Small airways function of subjects in both group(chronic obstructive pulmonary disease and asthma-chronic obstructive pulmonary disease overlap) is assessed at baseline.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 the same examinations after 3 months' treatment.
- Masking
- None (open label)
- Enrolment
- 80 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
- NCT03563001
- Sponsor's protocol ID
- 2016-HXNK-002
- Status last verified
- May 2018
- First submitted
- 23 May 2018
- Last updated
- 27 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 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences of Small Airways Function Between Chronic Obstructive Pulmonary Disease(COPD) and Asthma-copd Overlap(ACO)
- ClinicalTrials.gov ID
- NCT03563001
- Acronym / sponsor ID
- 2016-HXNK-002
- Conditions
- Pulmonary Disease, Chronic Obstructive, Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome, Small Airway Disease, Quality of Life
- Keywords
- chronic obstructive pulmonary disease, asthma-chronic obstructive pulmonary disease overlap, small airway, quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 20 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 research the differences of small airways function between subjects with diagnosis of chronic obstructive pulmonary disease(COPD) and asthma-COPD overlap(ACO).The assessment of quality of life is also carried out through questionnaires.
Detailed description
This is a randomized,open-label study to research the differences of small airways function between simple chronic obstructive pulmonary disease(COPD) and asthma-COPD overlap(ACO).Assessment of small airways is conducted at baseline,including forced expired volume in one second(FEV1),forced vital capacity(FVC),peak expiratory flow(PEF),maximum expiratory flow rate at 75% of vital capacity(MEF75),maximum expiratory flow rate at 50% of vital capacity(MEF50),maximum expiratory flow rate at 25% of vital capacity(MEF25),impulse oscillometry,diffusion function,residual volume(RV) and total lung capacity(TLC).Budesonide(160ug) and formoterol(4.5ug) bid will be given to both groups(chronic obstructive pulmonary disease and asthma-COPD overlap) for 3 months.Quality of life is assessed through questionnaires including modified Medical Research Council dyspnoea scale(mMRC),St George's Respiratory Questionnaire(SGRQ) and chronic obstructive pulmonary disease assessment test(CAT).All of the patients will have a follow-up visit after 3 months' treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with diagnosis of simple chronic obstructive pulmonary disease(COPD) and asthma-chronic obstructive pulmonary disease overlap(ACO) are recruited.Small airways function of subjects in both group(chronic obstructive pulmonary disease and asthma-chronic obstructive pulmonary disease overlap) is assessed at baseline.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 the same examinations after 3 months' treatment.
| Arm | Type | Receives |
|---|---|---|
| Chronic Obstructive Pulmonary Disease Group | Experimental | Drug: Budesonide(160ug) and Formoterol(4.5ug) bidPatients with diagnosis of chronic obstructive pulmonary disease according to Global Initiative for Chronic Obstructive Disease(GOLD 2018) are recruited.Small airways function of is assessed at baseline.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 the same examinations after 3 months' treatment. |
| Asthma-Chronic Obstructive Pulmonary Disease Overlap Group | Experimental | Drug: Budesonide(160ug) and Formoterol(4.5ug) bidPatients with diagnosis of asthma-chronic obstructive pulmonary disease overlap according to Global Initiative for Chronic Obstructive Disease(GOLD 2018),Global Initiative for Asthma(GINA 2018) and Spanish COPD Guidelines(GesEPOC 2017) are recruited.Small airways function of is assessed at baseline.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 the same examinations 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 (4 listed)
- Male or female patients 18 to 80 years-old.
- A diagnosis of chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Disease(GOLD 2018) guidelines are recruited to the chronic obstructive pulmonary disease group.A diagnosis of asthma-chronic obstructive pulmonary disease overlap according to Global Initiative for Chronic Obstructive Disease(GOLD 2018),Global Initiative for Asthma(GINA 2018) and Spanish COPD Guidelines(GesEPOC 2017) are recruited to the asthma-chronic obstructive pulmonary disease overlap group.
- 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(160ug) and Formoterol(4.5ug) bidAlso: SYMBICORT TURBUHALERFor both groups of subjects,small airways function of is assessed at baseline.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 the same examinations after 3 months' treatment. | Drug | Asthma-Chronic Obstructive Pulmonary Disease Overlap Group, Chronic Obstructive Pulmonary Disease Group |
Primary outcome
Differences of maximum expiratory flow rate at 75% of vital capacity(MEF75) between chronic obstructive pulmonary disease and asthma-chronic obstructive pulmonary disease overlap
Time frame: 3 months
Maximum expiratory flow rate at 75% of vital capacity(MEF75) is measured according to internationally accepted standards in both groups by Jaeger MasterScreen Pulmonary Function Test System.
16 secondary outcomes
Differences of maximum expiratory flow rate at 50% of vital capacity(MEF50) between two groups
Time frame: 3 months
Differences of maximum expiratory flow rate at 25% of vital capacity(MEF25) between two groups
Time frame: 3 months
Differences of impulse oscillometry parameters between two groups
Time frame: 3 months
Differences of diffusion function between two groups
Time frame: 3 months
Differences of residual volume(RV) between two groups
Time frame: 3 months
Differences of total lung capacity(TLC) between two groups
Time frame: 3 months
Changes of maximum expiratory flow rate at 75% of vital capacity(MEF75) after 3 months' treatment compared with baseline in both groups
Time frame: Change from baseline to 3 months
Changes of maximum expiratory flow rate at 50% of vital capacity(MEF50) after 3 months' treatment compared with baseline in both groups
Time frame: Change from baseline to 3 months
Changes of maximum expiratory flow rate at 25% of vital capacity(MEF25) after 3 months' treatment compared with baseline in both groups
Time frame: Change from baseline to 3 months
Changes of impulse oscillometry parameters(IOS) after 3 months' treatment compared with baseline in both groups
Time frame: Change from baseline to 3 months
Changes of diffusion function after 3 months' treatment compared with baseline in both groups
Time frame: Change from baseline to 3 months
Changes of total lung capacity(TLC) after 3 months' treatment compared with baseline in both groups
Time frame: Change from baseline to 3 months
Changes of residual volume(RV) after 3 months' treatment compared with baseline in both groups
Time frame: Change from baseline to 3 months
Change of St George's Respiratory Questionnaire(SGRQ) scores after 3 months' treatment compared with baseline
Time frame: Change from baseline to 3 months
Change of modified Medical Research Council dyspnoea scale(mMRC) scores after 3 months' treatment compared with baseline
Time frame: Change from baseline to 3 months
Change of chronic obstructive pulmonary disease assessment test(CAT) after 3 months' treatment compared with baseline
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 27 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(160ug) and Formoterol(4.5ug) bid in people with Pulmonary Disease, Chronic Obstructive and Asthma-Chronic Obstructive Pulmonary Disease Overlap Syndrome, 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 4 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 27 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?
Differences of maximum expiratory flow rate at 75% of vital capacity(MEF75) between chronic obstructive pulmonary disease and asthma-chronic obstructive pulmonary disease overlap (time frame: 3 months). 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 27 Jun 2018.