Pulmonary Disease, Chronic ObstructivePhase 3NCT01836016
A Randomized Comparative Effectiveness Research Trial of Three Treatments for COPD Patients
A Phase 3 study testing Salbutamol (Ventolin®), Formoterol (Oxis Turbuhaler®) and Salmeterol / fluticasone (Seretide®) in people with Pulmonary Disease, Chronic Obstructive, run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The aim of this study is to compare the effectiveness and economic evaluation of three treatments for Chronic Obstructive Pulmonary Disease (COPD) patients: one, conventional medicine based on 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines; another, TCM treatments… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Salbutamol (Ventolin®), Formoterol (Oxis Turbuhaler®) and Salmeterol / fluticasone (Seretide®)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- May 2013to May 2015
- Phase
- Phase 3
- 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
- A confirmed diagnosis of mild to very severe COPD.
- medically stable
- Age between 18 and 80 years.
- Syndrome differentiation belongs to Syndrome of lung-qi deficiency, Syndrome of deficiency of pulmonic-splenic qi, Syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney.
- Without participations in other interventional trials in the previous one month.
- With the informed consent signed.
Who cannot join
- Pregnant or breast-feeding women.
- Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study .
- Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within the last 5 years.
- Current respiratory disorders other than COPD (e.g., bronchiectasis, tuberculosis, lung fibrosis, pulmonary thromboembolic).
- Complicated with heart failure (NYHA Class III or IV),or myocardial infarction within six months ,or unstable hemodynamics.
- Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation).
- Participating in other trials or allergic to the used medicine.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, 450000
Jiansheng Li, MD
About this study
Official title: Comparison of Conventional Medicine, TCM Treatment and Combination of Both Conventional Medicine and TCM Treatment for Patients With Chronic Obstructive Pulmonary Disease: A Randomized Comparative Effectiveness Research Trial
The aim of this study is to compare the effectiveness and economic evaluation of three treatments for Chronic Obstructive Pulmonary Disease (COPD) patients: one, conventional medicine based on 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines; another, TCM treatments, which have been evaluated and have certain effect; and finally, combination of both conventional medicine and TCM treatment, then determine which treatment is the most suitable for COPD patients.
Read the detailed description
COPD affects millions worldwide. The high prevalence, morbidity, mortality and economic burdens of COPD are increasing steadily. Although many therapies exist and are being developed to relieve symptoms and reduce mortality in COPD, most have only been studied in placebo-controlled efficacy studies in highly selected populations. There are few clinical trials to compare therapeutic alternatives in real world. Much of the comparative research evidence in COPD has been based on observational studies. Furthermore, studies in real world populations of COPD that received different therapies that do have efficacy evidence was found wide variations in care delivery. These considerations highlight the need to identify the most effective therapies in real world COPD patients and to design and test efforts to translate this evidence into healthcare for the millions of COPD patients. In short, there is a need for comparative effectiveness research (CER) in COPD.
CER has received growing attention worldwide. The direct comparisons of treatment alternatives provided by CER can help patients and providers make best informed treatment decisions where such evidence was previously lacking. Some randomized controlled trials on comprehensive Traditional Chinese medicine (TCM) interventions, especially based on the TCM patterns, have been the certain evidence for showing definite effect for stable COPD patients. When facing many treatment approaches, how to choose the most suitable treatment is difficult to identify. Hence, the aim of this study is to compare the effectiveness and economic evaluation of three treatments for COPD patients and then determine which treatment is the most suitable for COPD patients. conventional medicine, TCM treatment and Combination of both conventional medicine and TCM treatment.
This is a multi-center, pragmatic, randomized, controlled trial to evaluate the effectiveness of three treatments in COPD subjects. Following a 14 day run-in period, approximately 360 subjects will be randomly assigned to one of the three treatments (conventional medicine, Traditional Chinese medicine, and combination of both conventional medicine and TCM treatment) for 26 weeks. After the 26 weeks treatment period, subjects in three treatments arms will follow-up 26 weeks. The primary outcome measure is the frequency of exacerbations. and. Secondary efficacy measures include FEV1, Dyspnea (MMRC), Exercise Capacity( 6MWD), Quality of life (CAT) and economic evaluation(CEA, CUA). Safety will be assessed through the collection of adverse events. There will be a total of 5 study visits (baseline, the 13, 26 weeks of the treatment, 13 and 26 weeks of follow-up). A follow-up contact for collection of effect and economic evaluation will be conducted approximately 26 weeks following the last study visit.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Salbutamol (Ventolin®), Formoterol (Oxis Turbuhaler®), Salmeterol / fluticasone (Seretide®), Bufei granule, Bufeijianpi granule
- Keywords
- Pulmonary Disease, Chronic Obstructive, Comparative effectiveness research, Medicine, Chinese Traditional, Humans, Treatment Outcome
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salbutamol (Ventolin®)Drug
Also called Group A patients: Salbutamol (Ventolin®).
According to the revised 2011 GOLD, patients will be divided into Group A, B, C, and D based on individualized assessment. Salbutamol was used to Group A patients for 26 weeks: Salbutamol (Ventolin®, GlaxoSmithKline) 100μg/dose, 200 inhalations. 100 μg each time (when needed), and the maximum dose is 8-12 inhalations a day.
Formoterol (Oxis Turbuhaler®)Drug
Also called Group B patients: Formoterol (Oxis Turbuhaler®).
According to the revised 2011 GOLD, patients will be divided into Group A, B, C, and D based on individualized assessment. Formoterol was used to Group B patients for 26 weeks: Formoterol (Oxis Turbuhaler®, AstraZeneca), 4.5μg/ dose, 60 inhalations. 4.5μg each time, twice daily.
Salmeterol / fluticasone (Seretide®)Drug
Also called Group C patients: Salmeterol / fluticasone (Seretide®)., Group D patients: Salmeterol / fluticasone (Seretide®).
According to the revised 2011 GOLD, patients will be divided into Group A, B, C, and D based on individualized assessment. Salmeterol / fluticasone was used to Group C patients and Group D patients for 26 weeks: Salmeterol / fluticasone (Seretide®, GlaxoSmithKline), 50/500 μg / dose, 60 inhalations. 50/500 μg each time, twice daily.
Bufei granuleDrug
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of lung-qi deficiency will be given Bufei granule, twice daily for 26 weeks for lower dosage.
Bufeijianpi granuleDrug
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of deficiency of pulmonic-splenic qi will be given Bufeijianpi granule, twice daily for 26 weeks for lower dosage.
Bufeiyishen granuleDrug
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given Bufeiyishen granule, twice daily for 26 weeks for lower dosage.
Yiqizishen granuleDrug
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi and yin of the lung and kidney will be given Yiqizishen granule, twice daily for 26 weeks for lower dosage.
conventional medicine + TCMDrug
Also called Both conventional medicine and traditional Chinese medicine
Patients will be given the combination of conventional medicine (Salbutamol, Formoterol, Salmeterol / fluticasone, Salmeterol / fluticasone) and (Bufei granule, Bufeijianpi granule, Bufeiyishen granule and Yiqizishen granule) for 26 weeks.
| Study group | Role | What they receive |
|---|---|---|
| conventional medicine | Experimental | According to the individualized assessment of symptoms and exacerbation risk recommended by revised 2011 GOLD, patients in this group will be given conventional medicine treatment including three drugs, which are Salbutamol (Ventolin®), Formoterol (Oxis Turbuhaler®), Salmeterol / fluticasone (Seretide®). Receives: Drug: Salbutamol (Ventolin®); Drug: Formoterol (Oxis Turbuhaler®); Drug: Salmeterol / fluticasone (Seretide®) |
| traditional Chinese medicine | Experimental | Patients in this group will receive four types of TCM treatment according to traditional Chinese syndrome differentiation and treatment, which are Bufei granule, Bufeijianpi granule, Bufeiyishen granule and Yiqizishen granule. Receives: Drug: Bufei granule; Drug: Bufeijianpi granule; Drug: Bufeiyishen granule; Drug: Yiqizishen granule |
| conventional medicine + TCM | Experimental | Patients in this group will receive conventional medicine and traditional Chinese medicine. Receives: Drug: conventional medicine + TCM |
What is being measured
The primary outcome is the main question the study is designed to answer.
the frequency of exacerbation
Measured: Change from Baseline in the frequency of exacerbation at Week 13 and 26 of the treatment phase, Week 13 and 26 of the follow-up phase.
Secondary outcomes (5)
Forced expiratory volume in one second
Forced expiratory volume in one second(FEV1) is the amount of air that can be exhaled in one second. A positive change from baseline in FEV1 indicates improvement in lung function.
Measured: Change from Baseline in FEV1 at Week 26 of the treatment phase, Week 26 of the follow-up phase.
Dyspnea
Using Modified Medical Research Council (MMRC) scale to assess a patient's level of dyspnea. The MMRC scale is a simple grading system that scored from 0 (less severe) to 4 (severe).
Measured: Change from Baseline in MMRC at Week 13 and 26 of the treatment phase, Week 13 and 26 of the follow-up phase.
6 Minutes Walking Distance Test(6MWD)
Measured: Change from Baseline in 6MWD at Week 13 and 26 of the treatment phase, Week 13 and 26 of the follow-up phase.
Quality of life
Using COPD Assessment Test ( CAT) to asses the impact of COPD on a person's life, and how this changes over time.
Measured: Change from Baseline in CAT at Week 13 and 26 of the treatment phase, Week 13 and 26 of the follow-up phase.
Economic Evaluation
Using Cost-Effective Analysis(CEA) and Cost Utility Analysis(CUA) to calculate the incremental cost-effectiveness ratio and incremental mean cost per quality-adjusted life year associated with three treatments
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiansheng Li, MD, Study chair, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836016
- Sponsor's protocol ID
- CER in COPD
- Status last verified
- Apr 2013
- First submitted
- 1 Apr 2013
- Last updated
- 19 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li JS, Xie Y, Li SY, Yu XQ. Comparison of conventional medicine, TCM treatment, and combination of both conventional medicine and TCM treatment for patients with chronic obstructive pulmonary disease: study protocol of a randomized comparative effectiveness research trial. Trials. 2014 May 1;15:153. doi: 10.1186/1745-6215-15-153.
PubMed 24885672
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conventional Medicine, TCM Treatment and Combination of Both Conventional Medicine and TCM Treatment for Patients With Chronic Obstructive Pulmonary Disease: A Randomized Comparative Effectiveness Research Trial
- ClinicalTrials.gov ID
- NCT01836016
- Acronym / sponsor ID
- CER in COPD
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, Comparative effectiveness research, Medicine, Chinese Traditional, Humans, Treatment Outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 19 Apr 2013 (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.
The aim of this study is to compare the effectiveness and economic evaluation of three treatments for Chronic Obstructive Pulmonary Disease (COPD) patients: one, conventional medicine based on 2011 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines; another, TCM treatments, which have been evaluated and have certain effect; and finally, combination of both conventional medicine and TCM treatment, then determine which treatment is the most suitable for COPD patients.
Detailed description
COPD affects millions worldwide. The high prevalence, morbidity, mortality and economic burdens of COPD are increasing steadily. Although many therapies exist and are being developed to relieve symptoms and reduce mortality in COPD, most have only been studied in placebo-controlled efficacy studies in highly selected populations. There are few clinical trials to compare therapeutic alternatives in real world. Much of the comparative research evidence in COPD has been based on observational studies. Furthermore, studies in real world populations of COPD that received different therapies that do have efficacy evidence was found wide variations in care delivery. These considerations highlight the need to identify the most effective therapies in real world COPD patients and to design and test efforts to translate this evidence into healthcare for the millions of COPD patients. In short, there is a need for comparative effectiveness research (CER) in COPD.
CER has received growing attention worldwide. The direct comparisons of treatment alternatives provided by CER can help patients and providers make best informed treatment decisions where such evidence was previously lacking. Some randomized controlled trials on comprehensive Traditional Chinese medicine (TCM) interventions, especially based on the TCM patterns, have been the certain evidence for showing definite effect for stable COPD patients. When facing many treatment approaches, how to choose the most suitable treatment is difficult to identify. Hence, the aim of this study is to compare the effectiveness and economic evaluation of three treatments for COPD patients and then determine which treatment is the most suitable for COPD patients. conventional medicine, TCM treatment and Combination of both conventional medicine and TCM treatment.
This is a multi-center, pragmatic, randomized, controlled trial to evaluate the effectiveness of three treatments in COPD subjects. Following a 14 day run-in period, approximately 360 subjects will be randomly assigned to one of the three treatments (conventional medicine, Traditional Chinese medicine, and combination of both conventional medicine and TCM treatment) for 26 weeks. After the 26 weeks treatment period, subjects in three treatments arms will follow-up 26 weeks. The primary outcome measure is the frequency of exacerbations. and. Secondary efficacy measures include FEV1, Dyspnea (MMRC), Exercise Capacity( 6MWD), Quality of life (CAT) and economic evaluation(CEA, CUA). Safety will be assessed through the collection of adverse events. There will be a total of 5 study visits (baseline, the 13, 26 weeks of the treatment, 13 and 26 weeks of follow-up). A follow-up contact for collection of effect and economic evaluation will be conducted approximately 26 weeks following the last study visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| conventional medicine | Experimental | Drug: Salbutamol (Ventolin®), Drug: Formoterol (Oxis Turbuhaler®), Drug: Salmeterol / fluticasone (Seretide®)According to the individualized assessment of symptoms and exacerbation risk recommended by revised 2011 GOLD, patients in this group will be given conventional medicine treatment including three drugs, which are Salbutamol (Ventolin®), Formoterol (Oxis Turbuhaler®), Salmeterol / fluticasone (Seretide®). |
| traditional Chinese medicine | Experimental | Drug: Bufei granule, Drug: Bufeijianpi granule, Drug: Bufeiyishen granule, Drug: Yiqizishen granulePatients in this group will receive four types of TCM treatment according to traditional Chinese syndrome differentiation and treatment, which are Bufei granule, Bufeijianpi granule, Bufeiyishen granule and Yiqizishen granule. |
| conventional medicine + TCM | Experimental | Drug: conventional medicine + TCMPatients in this group will receive conventional medicine and traditional Chinese medicine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A confirmed diagnosis of mild to very severe COPD.
- medically stable
- Age between 18 and 80 years.
- Syndrome differentiation belongs to Syndrome of lung-qi deficiency, Syndrome of deficiency of pulmonic-splenic qi, Syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney.
- Without participations in other interventional trials in the previous one month.
Key exclusion criteria (7 listed)
- Pregnant or breast-feeding women.
- Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study .
- Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within the last 5 years.
- Current respiratory disorders other than COPD (e.g., bronchiectasis, tuberculosis, lung fibrosis, pulmonary thromboembolic).
- Complicated with heart failure (NYHA Class III or IV),or myocardial infarction within six months ,or unstable hemodynamics.
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 |
|---|---|---|
| Salbutamol (Ventolin®)Also: Group A patients: Salbutamol (Ventolin®).According to the revised 2011 GOLD, patients will be divided into Group A, B, C, and D based on individualized assessment. Salbutamol was used to Group A patients for 26 weeks: Salbutamol (Ventolin®, GlaxoSmithKline) 100μg/dose, 200 inhalations. 100 μg each time (when needed), and the maximum dose is 8-12 inhalations a day. | Drug | conventional medicine |
| Formoterol (Oxis Turbuhaler®)Also: Group B patients: Formoterol (Oxis Turbuhaler®).According to the revised 2011 GOLD, patients will be divided into Group A, B, C, and D based on individualized assessment. Formoterol was used to Group B patients for 26 weeks: Formoterol (Oxis Turbuhaler®, AstraZeneca), 4.5μg/ dose, 60 inhalations. 4.5μg each time, twice daily. | Drug | conventional medicine |
| Salmeterol / fluticasone (Seretide®)Also: Group C patients: Salmeterol / fluticasone (Seretide®)., Group D patients: Salmeterol / fluticasone (Seretide®).According to the revised 2011 GOLD, patients will be divided into Group A, B, C, and D based on individualized assessment. Salmeterol / fluticasone was used to Group C patients and Group D patients for 26 weeks: Salmeterol / fluticasone (Seretide®, GlaxoSmithKline), 50/500 μg / dose, 60 inhalations. 50/500 μg each time, twice daily. | Drug | conventional medicine |
| Bufei granuleAccording to traditional Chinese syndrome differentiation and treatment, patients with syndrome of lung-qi deficiency will be given Bufei granule, twice daily for 26 weeks for lower dosage. | Drug | traditional Chinese medicine |
| Bufeijianpi granuleAccording to traditional Chinese syndrome differentiation and treatment, patients with syndrome of deficiency of pulmonic-splenic qi will be given Bufeijianpi granule, twice daily for 26 weeks for lower dosage. | Drug | traditional Chinese medicine |
| Bufeiyishen granuleAccording to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given Bufeiyishen granule, twice daily for 26 weeks for lower dosage. | Drug | traditional Chinese medicine |
| Yiqizishen granuleAccording to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi and yin of the lung and kidney will be given Yiqizishen granule, twice daily for 26 weeks for lower dosage. | Drug | traditional Chinese medicine |
| conventional medicine + TCMAlso: Both conventional medicine and traditional Chinese medicinePatients will be given the combination of conventional medicine (Salbutamol, Formoterol, Salmeterol / fluticasone, Salmeterol / fluticasone) and (Bufei granule, Bufeijianpi granule, Bufeiyishen granule and Yiqizishen granule) for 26 weeks. | Drug | conventional medicine + TCM |
Primary outcome
the frequency of exacerbation
Time frame: Change from Baseline in the frequency of exacerbation at Week 13 and 26 of the treatment phase, Week 13 and 26 of the follow-up phase.
5 secondary outcomes
Forced expiratory volume in one second
Time frame: Change from Baseline in FEV1 at Week 26 of the treatment phase, Week 26 of the follow-up phase.
Dyspnea
Time frame: Change from Baseline in MMRC at Week 13 and 26 of the treatment phase, Week 13 and 26 of the follow-up phase.
6 Minutes Walking Distance Test(6MWD)
Time frame: Change from Baseline in 6MWD at Week 13 and 26 of the treatment phase, Week 13 and 26 of the follow-up phase.
Quality of life
Time frame: Change from Baseline in CAT at Week 13 and 26 of the treatment phase, Week 13 and 26 of the follow-up phase.
Economic Evaluation
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2013.
- Derived from this study: PubMed 24885672Li JS, Xie Y, Li SY, Yu XQ. Comparison of conventional medicine, TCM treatment, and combination of both conventional medicine and TCM treatment for patients with chronic obstructive pulmonary disease: study protocol of a randomized comparative effectiveness research trial. Trials. 2014 May 1;15:153. doi: 10.1186/1745-6215-15-153.
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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.
Jiansheng Li, MD study chair
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Salbutamol (Ventolin®), Formoterol (Oxis Turbuhaler®) and Salmeterol / fluticasone (Seretide®) in people with Pulmonary Disease, Chronic Obstructive, run by Henan University of Traditional Chinese Medicine 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 6 inclusion and 7 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 19 Apr 2013. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Xueqing Yu, MD (+86 371 66248624, yxqshi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the frequency of exacerbation (time frame: Change from Baseline in the frequency of exacerbation at Week 13 and 26 of the treatment phase, Week 13 and 26 of the follow-up phase.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01836016, which also lists 1 linked publication.
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 19 Apr 2013.