Pulmonary Disease, Chronic ObstructivePhase 3NCT02270424
Effect of Traditional Chinese Medicine on Outcomes in Patients With Severe / Very Severe COPD
A Phase 3 study testing Salmeterol / fluticasone (Seretide®), Bufeijianpi granule and Bufeiyishen granule in people with Pulmonary Disease, Chronic Obstructive, run by Henan University of Traditional Chinese Medicine.
Trial summary
The aim of this study is to compare the effectiveness of two treatments for severe / very severe COPD patients: one, conventional medicine based on 2013 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines; the other, TCM treatments and conventional medicine, which have been… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Salmeterol / fluticasone (Seretide®), Bufeijianpi granule and Bufeiyishen granule
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 564 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Dec 2016
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A confirmed diagnosis of severe to very severe COPD.
- medically stable
- Age between 40 and 80 years.
- Syndrome differentiation belongs to syndrome of deficiency of pulmonosplenic qi, syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney.
- with a two-week wash-out period prior to randomization
- 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.
- Current respiratory disorders other than COPD (e.g., bronchiectasis, bronchial asthma, tuberculosis, lung fibrosis, pulmonary thromboembolic, diffuse panbronchiolitis).
- Complicated with a neuromuscular disorder, which affected the respiration.
- Complicated with heart failure (NYHA Class III or IV),or myocardial infarction within six months ,or unstable hemodynamics.
- Complicated with malignancy, congenital or acquired immune deficiency.
- 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
No sites are listed yet.
About this study
Official title: A Multi-center, Randomized, Double-blind, Controlled Study to Evaluate the Effectiveness of on Severe / Very Severe COPD Patients
The aim of this study is to compare the effectiveness of two treatments for severe / very severe COPD patients: one, conventional medicine based on 2013 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines; the other, TCM treatments and conventional medicine, which have been evaluated and have certain effect.
Read the detailed description
Patients with severe or very severe COPD are more likely to suffer repeated exacerbations and more rapidly declining lung function generating increased risk of death and time to a COPD related hospitalization. Although many therapies exist and are being developed to relieve symptoms and reduce mortality in COPD, most have only been studied in moderate to very severe COPD. There are few clinical trials to compare therapeutic alternatives in severe and very sever COPD. Furthermore, 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 COPD patients. In addition, a study about the effect of TCM on outcomes in mild and moderate COPD patients has been in progress and will be carried out in December 2014 (NCT01486186). Hence, corresponding to the mild to moderate COPD patients, The this study aims to evaluate the effectiveness of TCM on severe / very severe COPD patients.
This is a multi-center, randomized, double-blind, controlled study to evaluate the effectiveness of TCM on severe / very Severe COPD patients. Following a 14 day run-in period, approximately 564 subjects will be randomly assigned to conventional medicine treatment group, TCM and conventional medicine treatment group for 52 weeks. After the 52 weeks treatment period, subjects in two treatments arms will follow-up 52 weeks. The primary outcome measure is the frequency of exacerbations. The secondary efficacy measures include all-cause mortality, FEV1, dyspnea (MMRC), exercise capacity( 6MWD), quality of life ( CAT, SF-36 and COPD-PRO), and effectiveness satisfaction with treatment(ESQ-COPD) . Safety will be assessed through the collection of adverse events. There will be a total of 9 study visits (baseline, the 13, 26, 39 and 52 weeks of the treatment, the 13, 26, 39 and 52 weeks of follow-up).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Salmeterol / fluticasone (Seretide®), Bufeijianpi granule, Bufeiyishen granule, Yiqizishen granule, Placebo Bufeijianpi granule
- Keywords
- Pulmonary Disease, Chronic Obstructive, 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.
Salmeterol / fluticasone (Seretide®)Drug
According to the revised 2013 GOLD, Salmeterol / fluticasone was used to severe and very severe COPD patients for 52weeks: Salmeterol / fluticasone (Seretide®, GlaxoSmithKline), 50/500 μg / dose, 60 inhalations. 50/500 μg each time, twice daily.
Bufeijianpi granuleDrug
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of deficiency of pulmono-splenic qi will be given Bufeijianpi granule, twice daily for 52 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 52 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 granule, twice daily for 52 weeks for lower dosage.
Placebo Bufeijianpi granuleDrug
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of deficiency of pulmono-splenic qi will be given placebo Bufeijianpi granule, twice daily for 52 weeks for lower dosage.
Placebo 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 placebo Bufeiyishen granule, twice daily for 52 weeks for lower dosage.
Placebo 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 placebo Yiqizishen granule granule, twice daily for 52 weeks for lower dosage.
| Study group | Role | What they receive |
|---|---|---|
| Conventional medicine+ placebo TCM | Experimental | Patients in this group will be given conventional medicine, Salmeterol / fluticasone based on the classes of medications recommended by 2011 GOLD and Chinese Treatment Guidelines for COPD, and three placebo TCM treatment, which are which are placebo Bufeijianpi granule, placebo Bufeiyishen granule and placebo Yiqizishen granule corresponding to the three traditional Chinese syndromes in sequence, which are syndrome of deficiency of pulmono-splenic qi, syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney. Receives: Drug: Salmeterol / fluticasone (Seretide®); Drug: Placebo Bufeijianpi granule; Drug: Placebo Bufeiyishen granule; Drug: Placebo Yiqizishen granule |
| conventional medicine+ TCM | Experimental | Patients in this group will receive Salmeterol / fluticasone based on the classes of medications recommended by 2011 GOLD and Chinese Treatment Guidelines for COPD, and three types of TCM treatment, which are Bufeijianpi granule, Bufeiyishen granule and Yiqizishen granule. A herbal extract twice daily for 52 weeks for lower dosage. The three granules are corresponding to the three traditional Chinese syndromes in sequence, which are syndrome of deficiency of pulmono-splenic qi, syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney. Receives: Drug: Salmeterol / fluticasone (Seretide®); Drug: Bufeijianpi granule; Drug: Bufeiyishen granule; Drug: Yiqizishen granule |
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 the week13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup phase
Secondary outcomes (6)
Mortality
The mortality of COPD and all-cause mortality will be calculated.
Measured: 52 Weeks of the treatment phase and the 52 Weeks of the followup phase
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 the one second (FEV1) at the week13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup 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 the week13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup phase
6 Minutes Walking Distance Test ( 6MWD)
Measured: Change from Baseline in the 6MWD at the week 13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup phase.
Quality of life
Using three instruments, COPD Assessment Test ( CAT) , Short Form 36-Item Health Survey (SF-36) and patient reported outcome for chronic obstructive pulmonary disease (COPD-PRO), to asses the impact of COPD on a person's life, and how this changes over time.
Measured: Change from Baseline in the CAT, SF-36 and COPD-PRO at the week 13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup phase.
Effectiveness satisfaction with treatment
Using the effectiveness satisfaction questionnaire of chronic obstructive pulmonary disease (ESQ-COPD) to evaluate COPD patients' satisfaction with their treatment over time.
Measured: Change from Baseline in the ESQ-COPD at the week 13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 564 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, Doctor, Study chair, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270424
- Sponsor's protocol ID
- TCM for severe COPD
- Status last verified
- Oct 2014
- First submitted
- 17 Oct 2014
- Last updated
- 21 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Li J, Xie Y, Wang M, Li S, Yu X, Zhang N, Zhu Z, Zhang W, Feng J, Sun Z, Lin L, Sun Z, Zhang H, Yu X. Effect of traditional Chinese medicine combined with conventional Western medicine for patients with severe/very severe chronic obstructive pulmonary disease: a multi-center, randomized, double-blind, controlled study. Chin Med. 2025 May 20;20(1):66. doi: 10.1186/s13020-025-01117-x.
PubMed 40394700
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Controlled Study to Evaluate the Effectiveness of on Severe / Very Severe COPD Patients
- ClinicalTrials.gov ID
- NCT02270424
- Acronym / sponsor ID
- TCM for severe COPD
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, Medicine, Chinese Traditional, Humans, Treatment Outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 564 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 21 Oct 2014 (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 of two treatments for severe / very severe COPD patients: one, conventional medicine based on 2013 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines; the other, TCM treatments and conventional medicine, which have been evaluated and have certain effect.
Detailed description
Patients with severe or very severe COPD are more likely to suffer repeated exacerbations and more rapidly declining lung function generating increased risk of death and time to a COPD related hospitalization. Although many therapies exist and are being developed to relieve symptoms and reduce mortality in COPD, most have only been studied in moderate to very severe COPD. There are few clinical trials to compare therapeutic alternatives in severe and very sever COPD. Furthermore, 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 COPD patients. In addition, a study about the effect of TCM on outcomes in mild and moderate COPD patients has been in progress and will be carried out in December 2014 (NCT01486186). Hence, corresponding to the mild to moderate COPD patients, The this study aims to evaluate the effectiveness of TCM on severe / very severe COPD patients.
This is a multi-center, randomized, double-blind, controlled study to evaluate the effectiveness of TCM on severe / very Severe COPD patients. Following a 14 day run-in period, approximately 564 subjects will be randomly assigned to conventional medicine treatment group, TCM and conventional medicine treatment group for 52 weeks. After the 52 weeks treatment period, subjects in two treatments arms will follow-up 52 weeks. The primary outcome measure is the frequency of exacerbations. The secondary efficacy measures include all-cause mortality, FEV1, dyspnea (MMRC), exercise capacity( 6MWD), quality of life ( CAT, SF-36 and COPD-PRO), and effectiveness satisfaction with treatment(ESQ-COPD) . Safety will be assessed through the collection of adverse events. There will be a total of 9 study visits (baseline, the 13, 26, 39 and 52 weeks of the treatment, the 13, 26, 39 and 52 weeks of follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional medicine+ placebo TCM | Experimental | Drug: Salmeterol / fluticasone (Seretide®), Drug: Placebo Bufeijianpi granule, Drug: Placebo Bufeiyishen granule, Drug: Placebo Yiqizishen granulePatients in this group will be given conventional medicine, Salmeterol / fluticasone based on the classes of medications recommended by 2011 GOLD and Chinese Treatment Guidelines for COPD, and three placebo TCM treatment, which are which are placebo Bufeijianpi granule, placebo Bufeiyishen granule and placebo Yiqizishen granule corresponding to the three traditional Chinese syndromes in sequence, which are syndrome of deficiency of pulmono-splenic qi, syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney. |
| conventional medicine+ TCM | Experimental | Drug: Salmeterol / fluticasone (Seretide®), Drug: Bufeijianpi granule, Drug: Bufeiyishen granule, Drug: Yiqizishen granulePatients in this group will receive Salmeterol / fluticasone based on the classes of medications recommended by 2011 GOLD and Chinese Treatment Guidelines for COPD, and three types of TCM treatment, which are Bufeijianpi granule, Bufeiyishen granule and Yiqizishen granule. A herbal extract twice daily for 52 weeks for lower dosage. The three granules are corresponding to the three traditional Chinese syndromes in sequence, which are syndrome of deficiency of pulmono-splenic qi, syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A confirmed diagnosis of severe to very severe COPD.
- medically stable
- Age between 40 and 80 years.
- Syndrome differentiation belongs to syndrome of deficiency of pulmonosplenic qi, syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney.
- with a two-week wash-out period prior to randomization
Key exclusion criteria (8 listed)
- Pregnant or breast-feeding women.
- Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
- Current respiratory disorders other than COPD (e.g., bronchiectasis, bronchial asthma, tuberculosis, lung fibrosis, pulmonary thromboembolic, diffuse panbronchiolitis).
- Complicated with a neuromuscular disorder, which affected the respiration.
- 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 |
|---|---|---|
| Salmeterol / fluticasone (Seretide®)According to the revised 2013 GOLD, Salmeterol / fluticasone was used to severe and very severe COPD patients for 52weeks: Salmeterol / fluticasone (Seretide®, GlaxoSmithKline), 50/500 μg / dose, 60 inhalations. 50/500 μg each time, twice daily. | Drug | Conventional medicine+ placebo TCM, conventional medicine+ TCM |
| Bufeijianpi granuleAccording to traditional Chinese syndrome differentiation and treatment, patients with syndrome of deficiency of pulmono-splenic qi will be given Bufeijianpi granule, twice daily for 52 weeks for lower dosage. | Drug | conventional medicine+ TCM |
| 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 52 weeks for lower dosage. | Drug | conventional medicine+ TCM |
| 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 granule, twice daily for 52 weeks for lower dosage. | Drug | conventional medicine+ TCM |
| Placebo Bufeijianpi granuleAccording to traditional Chinese syndrome differentiation and treatment, patients with syndrome of deficiency of pulmono-splenic qi will be given placebo Bufeijianpi granule, twice daily for 52 weeks for lower dosage. | Drug | Conventional medicine+ placebo TCM |
| Placebo Bufeiyishen granuleAccording to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given placebo Bufeiyishen granule, twice daily for 52 weeks for lower dosage. | Drug | Conventional medicine+ placebo TCM |
| Placebo 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 placebo Yiqizishen granule granule, twice daily for 52 weeks for lower dosage. | Drug | Conventional medicine+ placebo TCM |
Primary outcome
The frequency of exacerbation
Time frame: Change from Baseline in the frequency of exacerbation at the week13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup phase
6 secondary outcomes
Mortality
Time frame: 52 Weeks of the treatment phase and the 52 Weeks of the followup phase
Forced expiratory volume in one second
Time frame: Change from Baseline in the one second (FEV1) at the week13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup phase.
Dyspnea
Time frame: Change from Baseline in MMRC at the week13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup phase
6 Minutes Walking Distance Test ( 6MWD)
Time frame: Change from Baseline in the 6MWD at the week 13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup phase.
Quality of life
Time frame: Change from Baseline in the CAT, SF-36 and COPD-PRO at the week 13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup phase.
Effectiveness satisfaction with treatment
Time frame: Change from Baseline in the ESQ-COPD at the week 13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup phase.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.
- Derived from this study: PubMed 40394700Li J, Xie Y, Wang M, Li S, Yu X, Zhang N, Zhu Z, Zhang W, Feng J, Sun Z, Lin L, Sun Z, Zhang H, Yu X. Effect of traditional Chinese medicine combined with conventional Western medicine for patients with severe/very severe chronic obstructive pulmonary disease: a multi-center, randomized, double-blind, controlled study. Chin Med. 2025 May 20;20(1):66. doi: 10.1186/s13020-025-01117-x.
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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, Doctor study chair
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Salmeterol / fluticasone (Seretide®), Bufeijianpi granule and Bufeiyishen granule in people with Pulmonary Disease, Chronic Obstructive, run by Henan University of Traditional Chinese Medicine.
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 7 inclusion and 8 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 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
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, Doctor (+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 the week13, 26, 39 and 52 of the treatment phase, the week 13, 26, 39 and 52 of the followup 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 NCT02270424, 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 21 Oct 2014.