Pulmonary Disease，Chronic Obstructive;Phase 4NCT02526758
Small Airways Evaluation and Treatment
A Phase 4 study testing beclomethasone, formoterol and budesonide in people with Pulmonary Disease，Chronic Obstructive;, run by Zhujiang Hospital at 1 site in China.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a common disease , and characterized by progressive development of airflow limitation. Small airway disease (obstructive bronchitis) and lung parenchyma damage (emphysema) are the main mechanisms of chronic airflow limitation. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Pulmonary Disease，Chronic Obstructive;
- What is being tested?
- beclomethasone, formoterol and budesonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to May 2016
- 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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of chronic obstructive pulmonary disease;
- More than 40 years;
Who cannot join
- asthma , or combined with bronchiectasia，pneumonia in the right upper lobe;
- Malignant tumor in the lung or other parts of the body;
- Uncontrolled hypertension (systolic blood pressure >200 mmHg, diastolic blood pressure >100 mmHg);
- Severe cardiac insufficiency, arrhythmia;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital
Guangzhou, Guangdong, 510280
Shuhan Wu, Master, 13268268627, 664397041@qq.com
About this study
Official title: Evaluation and Treatment of Small Airways in COPD
Chronic obstructive pulmonary disease (COPD) is a common disease , and characterized by progressive development of airflow limitation. Small airway disease (obstructive bronchitis) and lung parenchyma damage (emphysema) are the main mechanisms of chronic airflow limitation. Research shows that small airway resistance increased by 4-40 times in COPD patients, and become the main part of the airflow obstruction. Impulse oscillation system (IOS) is able to measure the total airway resistance, the central airway resistance and the peripheral airway resistance, which is now widely used to assess small airway function in COPD patients. While High resolution CT (HRCT) is easy to operate and its images are intuitive. Meanwhile it can measure the proportion of emphysema, the airway diameter and the thickness of airway wall. Both of these two tests have great significance in small airway evaluation. Chronic obstructive pulmonary disease with acute exacerbation (AECOPD) is an acute onset process, which is characterized by the aggravation of respiratory symptoms and deterioration of pulmonary function. However, the structural and functional changes of small airway in AECOPD are not clear. Inhalation drugs are the main treatment for stable COPD , and inhaled corticosteroid（ICS）+long-acting beta2-agonist（LABA） are used to treat patients with severe and severe airflow limitation. The particles in traditional inhalation drugs are larger and mainly deposited in large airways, and their effects on small airway function are relatively small.
The objectives of the investigators study are COPD patients. The study is divided into two parts, that is the part of AECOPD patients and the part of stable patients . Patients with AECOPD are arranged to take HRCT and IOS test to assess the small airway changes.Patients with stable COPD are randomized to take either beclomethasone / formoterol (particle diameter for 1.4-1.5um) or budesonide / formoterol (3.2um) for three months. The structure and function changes of small airway in different stage will be evaluated and the efficacy of these two drugs is to be compared. This study is expected to highlight the investigators understanding on the role of small airways in COPD, and provide a guideline to clinical standardized treatment as well as evaluation of patients' conditions.
Read the detailed description
The COPD patients in the investigators hospital are selected to participate in the investigators study, and strict inclusion and exclusion criteria are to be complied with. All the subjects will be told the details of the study and sign the informed consent before inclusion.HRCT will be used to evaluate the structure of small airway by measuring the thickness of the third stage branches of apical segmental bronchus in the right upper lobe (WT). R5-R20 measured by IOS will be used to assess small airway resistance.
The study is divided into two parts, that is the part of AECOPD patients and the part of stable patients . Both of them have three steps .
Part 1. AECOPD patients:
- Subjects screening : To inquire the history of the disease and to take the IOS and Bronchial dilation test.
- Baseline data collection：patients will be arranged to complete a series of questionnaires, as well as HRCT, IOS, pulmonary function test and 6 minute walk test.
- Test stage：During their hospital stay, the patients are to be treated with oxygen inhalation and different kinds of drugs, and the patients will followed up for three weeks after discharge. Completing the examinations and questionnaires at each time visit ,and another CT scan at the last visit.
Part 2. Stable COPD patients:
- Subjects screening : To inquire the history of the disease and to take the IOS and Bronchial dilation test.
- Baseline data collection：In the two-week washout period，patients are only allowed take salmeterol/fluticasone 50:250ug 2 times daily, and stop the use of other inhalation drugs and oral glucocorticoid. At the end of this period, complete a series of questionnaires, as well as HRCT, IOS, pulmonary function test and 6 minute walk test.
- Test stage： patients are randomized to take either beclomethasone / formoterol (100:6ug 2inhalations twice daily ) or budesonide / formoterol (160:4.5ug 2inhalations twice daily) for three months.Completing the examinations and questionnaires at the end of each month, another CT scan at the last visit.
- Conditions
- Pulmonary Disease，Chronic Obstructive;
- Being tested
- beclomethasone, formoterol, budesonide
- Keywords
- Pulmonary disease, chronic obstructive, small airway
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beclomethasoneDrug
Also called Beclomethasone Dipropionate,BDP
formoterolDrug
budesonideDrug
| Study group | Role | What they receive |
|---|---|---|
| beclomethasone / formoterol | Experimental | beclomethasone 100ug and formoterol 6ug , 2 inhalations, twice daily ,for three months Receives: Drug: beclomethasone; Drug: formoterol |
| budesonide / formoterol | Active comparator | budesonide 160ug and formoterol 4.5ug, 2 inhalations ,twice daily ,for three month Receives: Drug: formoterol; Drug: budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
R5-R20 measured by IOS
Change of small airway resistance (R5-R20)measured by IOS at three months
Measured: three month
Secondary outcomes (5)
forced expiratory volume at one second（FEV1）
change of forced expiratory volume at one second（FEV1） measured by pulmonary function test（PFT）at three months
Measured: three month
Score of symptoms using the St. George respiratory questionnaire
The St. George respiratory questionnaire
Measured: three month
Score of symptoms using modified Medical Research Council Dyspnoea Scale(mMRC)
modified Medical Research Council Dyspnoea Scale(mMRC)
Measured: three month
Score of symptoms
CAT
Measured: three month
Change of wall thickness（WT）
change of thickness of the third stage branches of apical segmental bronchus in the right upper lobe (WT) in three months
Measured: three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (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 Obstructive;Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huizhen Fan, Doctor, Study chair, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526758
- Sponsor's protocol ID
- SACOPD2015
- Status last verified
- Aug 2015
- First submitted
- 10 Aug 2015
- Last updated
- 18 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Treatment of Small Airways in COPD
- ClinicalTrials.gov ID
- NCT02526758
- Acronym / sponsor ID
- SACOPD2015
- Conditions
- Pulmonary Disease，Chronic Obstructive;
- Keywords
- Pulmonary disease, chronic obstructive, small airway
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 18 Aug 2015 (estimated)
- 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.
Chronic obstructive pulmonary disease (COPD) is a common disease , and characterized by progressive development of airflow limitation. Small airway disease (obstructive bronchitis) and lung parenchyma damage (emphysema) are the main mechanisms of chronic airflow limitation. Research shows that small airway resistance increased by 4-40 times in COPD patients, and become the main part of the airflow obstruction. Impulse oscillation system (IOS) is able to measure the total airway resistance, the central airway resistance and the peripheral airway resistance, which is now widely used to assess small airway function in COPD patients. While High resolution CT (HRCT) is easy to operate and its images are intuitive. Meanwhile it can measure the proportion of emphysema, the airway diameter and the thickness of airway wall. Both of these two tests have great significance in small airway evaluation. Chronic obstructive pulmonary disease with acute exacerbation (AECOPD) is an acute onset process, which is characterized by the aggravation of respiratory symptoms and deterioration of pulmonary function. However, the structural and functional changes of small airway in AECOPD are not clear. Inhalation drugs are the main treatment for stable COPD , and inhaled corticosteroid（ICS）+long-acting beta2-agonist（LABA） are used to treat patients with severe and severe airflow limitation. The particles in traditional inhalation drugs are larger and mainly deposited in large airways, and their effects on small airway function are relatively small.
The objectives of the investigators study are COPD patients. The study is divided into two parts, that is the part of AECOPD patients and the part of stable patients . Patients with AECOPD are arranged to take HRCT and IOS test to assess the small airway changes.Patients with stable COPD are randomized to take either beclomethasone / formoterol (particle diameter for 1.4-1.5um) or budesonide / formoterol (3.2um) for three months. The structure and function changes of small airway in different stage will be evaluated and the efficacy of these two drugs is to be compared. This study is expected to highlight the investigators understanding on the role of small airways in COPD, and provide a guideline to clinical standardized treatment as well as evaluation of patients' conditions.
Detailed description
The COPD patients in the investigators hospital are selected to participate in the investigators study, and strict inclusion and exclusion criteria are to be complied with. All the subjects will be told the details of the study and sign the informed consent before inclusion.HRCT will be used to evaluate the structure of small airway by measuring the thickness of the third stage branches of apical segmental bronchus in the right upper lobe (WT). R5-R20 measured by IOS will be used to assess small airway resistance.
The study is divided into two parts, that is the part of AECOPD patients and the part of stable patients . Both of them have three steps .
Part 1. AECOPD patients:
- Subjects screening : To inquire the history of the disease and to take the IOS and Bronchial dilation test.
- Baseline data collection：patients will be arranged to complete a series of questionnaires, as well as HRCT, IOS, pulmonary function test and 6 minute walk test.
- Test stage：During their hospital stay, the patients are to be treated with oxygen inhalation and different kinds of drugs, and the patients will followed up for three weeks after discharge. Completing the examinations and questionnaires at each time visit ,and another CT scan at the last visit.
Part 2. Stable COPD patients:
- Subjects screening : To inquire the history of the disease and to take the IOS and Bronchial dilation test.
- Baseline data collection：In the two-week washout period，patients are only allowed take salmeterol/fluticasone 50:250ug 2 times daily, and stop the use of other inhalation drugs and oral glucocorticoid. At the end of this period, complete a series of questionnaires, as well as HRCT, IOS, pulmonary function test and 6 minute walk test.
- Test stage： patients are randomized to take either beclomethasone / formoterol (100:6ug 2inhalations twice daily ) or budesonide / formoterol (160:4.5ug 2inhalations twice daily) for three months.Completing the examinations and questionnaires at the end of each month, another CT scan at the last visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| beclomethasone / formoterol | Experimental | Drug: beclomethasone, Drug: formoterolbeclomethasone 100ug and formoterol 6ug , 2 inhalations, twice daily ,for three months |
| budesonide / formoterol | Active comparator | Drug: formoterol, Drug: budesonidebudesonide 160ug and formoterol 4.5ug, 2 inhalations ,twice daily ,for three month |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of chronic obstructive pulmonary disease;
- More than 40 years;
Key exclusion criteria (4 listed)
- asthma , or combined with bronchiectasia，pneumonia in the right upper lobe;
- Malignant tumor in the lung or other parts of the body;
- Uncontrolled hypertension (systolic blood pressure >200 mmHg, diastolic blood pressure >100 mmHg);
- Severe cardiac insufficiency, arrhythmia;
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 |
|---|---|---|
| beclomethasoneAlso: Beclomethasone Dipropionate,BDP | Drug | beclomethasone / formoterol |
| formoterol | Drug | beclomethasone / formoterol, budesonide / formoterol |
| budesonide | Drug | budesonide / formoterol |
Primary outcome
R5-R20 measured by IOS
Time frame: three month
Change of small airway resistance (R5-R20)measured by IOS at three months
5 secondary outcomes
forced expiratory volume at one second（FEV1）
Time frame: three month
Score of symptoms using the St. George respiratory questionnaire
Time frame: three month
Score of symptoms using modified Medical Research Council Dyspnoea Scale(mMRC)
Time frame: three month
Score of symptoms
Time frame: three month
Change of wall thickness（WT）
Time frame: three month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2015.
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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.
Huizhen Fan, Doctor study chair
Zhujiang Hospital
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 beclomethasone, formoterol and budesonide in people with Pulmonary Disease，Chronic Obstructive;, 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 2 inclusion and 4 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 18 Aug 2015. 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 Shuhan Wu, Master (13268268627, 664397041@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R5-R20 measured by IOS (time frame: three month). 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 18 Aug 2015.