Pulmonary Disease, Chronic ObstructivePhase 3NCT03745261
Effect of Yong Chong Cao Capsule on Outcomes in Patients With Mild to Severe COPD
A Phase 3 study testing Salbutamol (Ventolin®), Tiotropium Bromide (Spiriva®) 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 evaluate the effectiveness of Yong Chong Cao capsule on outcomes in patients with mild to severe Chronic Obstructive Pulmonary Disease (COPD). 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®), Tiotropium Bromide (Spiriva®) and Salmeterol / fluticasone (Seretide®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2018to Jun 2020
- 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 severe COPD.
- Medically stable.
- Syndrome differentiation belongs to syndrome of insufficiency of qi of the lung and kidney.
- Age between 18 and 80 years.
- With the informed consent signed.
Who cannot join
- Pregnant or breast-feeding women.
- Current respiratory disorders other than COPD (e.g., bronchiectasis, bronchial asthma, tuberculosis, lung fibrosis, pulmonary thromboembolic, diffuse panbronchiolitis, lung cancer).
- 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).
- Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
- Participating in other trials or allergic to the used medicine.
- Participating in other clinical trials with other interventions in one month.
- Allergic to the used medicine.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, 450000
Yang Xie, Doctor, +8637166248624, xieyanghn@163.com
About this study
Official title: A Multi-center, Open-label, Randomized, Controlled Study to Evaluate the Effectiveness of Yong Chong Cao Capsule on Outcomes in Patients With Mild to Severe COPD
The aim of this study is to evaluate the effectiveness of Yong Chong Cao capsule on outcomes in patients with mild to severe Chronic Obstructive Pulmonary Disease (COPD).
Read the detailed description
The aim of this study is to compare the effectiveness of two treatments for mild to severe COPD patients: one, Yong Chong Cao capsule treatment and conventional medicine based on 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines; the other, Bailing capsule treatment and conventional medicine.
COPD, with high prevalence, morbidity, mortality and economic burdens, affects millions worldwide. 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. Furthermore, some randomized controlled trials on Yong Chong Cao capsule, one therapeutic type of Cordyceps sinensis in traditional Chinese medicine (TCM) interventions, especially based on the syndrome of insufficiency of qi of the lung and kidney patterns, have been the certain evidence for showing definite effect for COPD patients. In addition, studies in real world populations of COPD that received different cordyceps sinensis therapies that do have efficacy evidence was found wide variations in care delivery. In short, there is a need to compare the effectiveness of two capsule in patients with mild to severe COPD.
This is a multi-center, open-label, randomized, controlled study to evaluate the effectiveness of Yong Chong Cao capsule for patients with mild to severe COPD compared with Bailing capsule. Following a 14 day run-in period, approximately 240 subjects will be randomly assigned to Yong Chong Cao capsule treatment group, Bailing capsule treatment group for 24 weeks. After the 24 weeks treatment period, subjects in two treatments arms will follow-up 24 weeks. The primary outcome measure is the frequency of exacerbations. The secondary efficacy measures include FEV1, dyspnea (MMRC), exercise capacity(6MWD), quality of life (CAT, SGRQ). Safety will be assessed through the collection of adverse events. There will be a total of 4 study visits (baseline, the 12 and 24 weeks of the treatment, the 24 weeks of follow-up).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Salbutamol (Ventolin®), Tiotropium Bromide (Spiriva®), Salmeterol / fluticasone (Seretide®), YCC capsule, BL capsule
- Keywords
- Pulmonary Disease, Chronic Obstructive, mild, moderate, severe, Medicine, Chinese Traditional, Cordyceps sinensis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lymphoma, Follicular
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 2017 GOLD, patients will be divided into Group A, B, C, and D based on individualized assessment. Salbutamol will be used to Group A patients: Salbutamol (Ventolin®, GlaxoSmithKline) 100μg/dose. 100 μg each time (when needed), and the maximum dose is 8-12 inhalations a day.
Tiotropium Bromide (Spiriva®)Drug
Also called Group B and C patients: Tiotropium Bromide (Spiriva®)
Tiotropium Bromide Powder for Inhalation will be used to Group B and Group C patients: Tiotropium Bromide Powder for Inhalation(Spiriva®, Boehringer Ingelheim), 18μg/ capsule, 10 capsules. 18μg each time, once daily.
Salmeterol / fluticasone (Seretide®)Drug
Also called Group D patients: Salmeterol / fluticasone (Seretide®)
Salmeterol / fluticasone will be used to Group D patients: Salmeterol / fluticasone (Seretide®, GlaxoSmithKline), 50/250 μg / dose, 60 inhalations. 50/250 μg each time, twice daily.
YCC capsuleDrug
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given Yong Chong Cao (YCC)capsule (Kecai®, Guangdong daguang pharmaceutical group Co., Ltd), 1 g each time, three times a day.
BL capsuleDrug
According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given Bailing(BL) capsule (Bailing®, Huadong Medicine Co.,Ltd), 1 g each time, three times a day
| Study group | Role | What they receive |
|---|---|---|
| YCC capsule+conventional medicine | Experimental | Patients in this group will be given Yong Chong Cao (YCC) capsule and conventional medicine based on the classes of medications recommended by 2017 GOLD and Chinese Treatment Guidelines for COPD,which are Group A patients: Salbutamol (Ventolin®),Group B and Group C patients: Tiotropium Bromide (Spiriva®),Group D patients: Salmeterol / fluticasone (Seretide®). Receives: Drug: Salbutamol (Ventolin®); Drug: Tiotropium Bromide (Spiriva®); Drug: Salmeterol / fluticasone (Seretide®); Drug: YCC capsule |
| BL capsule + conventional medicine | Experimental | Patients in this group will be given Bailing (BL) capsule and conventional medicine based on the classes of medications recommended by 2017 GOLD and Chinese Treatment Guidelines for COPD, which are Group A patients: Salbutamol (Ventolin®),Group B and Group C patients: Tiotropium Bromide (Spiriva®),Group D patients: Salmeterol / fluticasone (Seretide®). Receives: Drug: Salbutamol (Ventolin®); Drug: Tiotropium Bromide (Spiriva®); Drug: Salmeterol / fluticasone (Seretide®); Drug: BL capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of exacerbation of COPD
The exacerbation of COPD often results in reduced quality of life, increased rate of lung function decline, increased hospitalization. It is important to assess the changes of exacerbations over time.
Measured: Changes in the frequency of exacerbation at the week 12 and week 24 of the treatment phase, and at the week 24 of the follow-up phase compared with baseline.
Secondary outcomes (6)
Changes in Modified Medical Research Council scale scores
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: Changes in the mMRC scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.
Changes in 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: Changes in FEV1 at the week 24 of the treatment phase and the week 24 of the follow-up phase compared with baseline.
Changes in COPD Assessment Test scores
Using the COPD Assessment Test ( CAT) , to assess the impact of COPD on a person's symptom, and how this changes over time.
Measured: Changes in the CAT scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.
Changes in Six Minutes Walking Distance
Using the results of six Minutes Walking Distance (6MWD)Test to assess the exercise tolerance.
Measured: Changes in the 6WMD scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.
Changes in St Georges respiratory questionnaire scores
Using the St. George's Respiratory Questionnaire(SGRQ), to assess the impact of COPD on a person's life, and how this changes over time.
Measured: Changes in the SGRQ scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.
Changes in clinical COPD questionnaire scores
Using the clinical COPD questionnaire (CCQ), to assess the impact of COPD on a person's life, and how this changes over time.
Measured: Changes in the CCQ scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start20 Jun 2018
- Primary completionDec 2019 (estimated)
- Study completionJun 2020 (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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Famous Medical Technology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Suyun Li, Doctor, Principal investigator, The First Affiliated Hospital of HUCM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745261
- Sponsor's protocol ID
- Yong Chong Cao for COPD
- Status last verified
- Nov 2018
- First submitted
- 15 Nov 2018
- Last updated
- 19 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li S, Xie Y, Lin L, Wu L, Yu X, Ma Z, Yin Q. The Effectiveness of Yong Chong Cao Capsule in Patients With Mild to Severe COPD: A Multi-Center, Randomized, Active-Controlled Trial. J Evid Based Med. 2025 Dec;18(4):e70091. doi: 10.1111/jebm.70091. Epub 2025 Nov 26.
PubMed 41295088
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Open-label, Randomized, Controlled Study to Evaluate the Effectiveness of Yong Chong Cao Capsule on Outcomes in Patients With Mild to Severe COPD
- ClinicalTrials.gov ID
- NCT03745261
- Acronym / sponsor ID
- Yong Chong Cao for COPD
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, mild, moderate, severe, Medicine, Chinese Traditional, Cordyceps sinensis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Jiangsu Famous Medical Technology Co., Ltd.
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 19 Nov 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 aim of this study is to evaluate the effectiveness of Yong Chong Cao capsule on outcomes in patients with mild to severe Chronic Obstructive Pulmonary Disease (COPD).
Detailed description
The aim of this study is to compare the effectiveness of two treatments for mild to severe COPD patients: one, Yong Chong Cao capsule treatment and conventional medicine based on 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines; the other, Bailing capsule treatment and conventional medicine.
COPD, with high prevalence, morbidity, mortality and economic burdens, affects millions worldwide. 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. Furthermore, some randomized controlled trials on Yong Chong Cao capsule, one therapeutic type of Cordyceps sinensis in traditional Chinese medicine (TCM) interventions, especially based on the syndrome of insufficiency of qi of the lung and kidney patterns, have been the certain evidence for showing definite effect for COPD patients. In addition, studies in real world populations of COPD that received different cordyceps sinensis therapies that do have efficacy evidence was found wide variations in care delivery. In short, there is a need to compare the effectiveness of two capsule in patients with mild to severe COPD.
This is a multi-center, open-label, randomized, controlled study to evaluate the effectiveness of Yong Chong Cao capsule for patients with mild to severe COPD compared with Bailing capsule. Following a 14 day run-in period, approximately 240 subjects will be randomly assigned to Yong Chong Cao capsule treatment group, Bailing capsule treatment group for 24 weeks. After the 24 weeks treatment period, subjects in two treatments arms will follow-up 24 weeks. The primary outcome measure is the frequency of exacerbations. The secondary efficacy measures include FEV1, dyspnea (MMRC), exercise capacity(6MWD), quality of life (CAT, SGRQ). Safety will be assessed through the collection of adverse events. There will be a total of 4 study visits (baseline, the 12 and 24 weeks of the treatment, the 24 weeks of follow-up).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YCC capsule+conventional medicine | Experimental | Drug: Salbutamol (Ventolin®), Drug: Tiotropium Bromide (Spiriva®), Drug: Salmeterol / fluticasone (Seretide®), Drug: YCC capsulePatients in this group will be given Yong Chong Cao (YCC) capsule and conventional medicine based on the classes of medications recommended by 2017 GOLD and Chinese Treatment Guidelines for COPD,which are Group A patients: Salbutamol (Ventolin®),Group B and Group C patients: Tiotropium Bromide (Spiriva®),Group D patients: Salmeterol / fluticasone (Seretide®). |
| BL capsule + conventional medicine | Experimental | Drug: Salbutamol (Ventolin®), Drug: Tiotropium Bromide (Spiriva®), Drug: Salmeterol / fluticasone (Seretide®), Drug: BL capsulePatients in this group will be given Bailing (BL) capsule and conventional medicine based on the classes of medications recommended by 2017 GOLD and Chinese Treatment Guidelines for COPD, which are Group A patients: Salbutamol (Ventolin®),Group B and Group C patients: Tiotropium Bromide (Spiriva®),Group D patients: Salmeterol / fluticasone (Seretide®). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A confirmed diagnosis of mild to severe COPD.
- Medically stable.
- Syndrome differentiation belongs to syndrome of insufficiency of qi of the lung and kidney.
- Age between 18 and 80 years.
- With the informed consent signed.
Key exclusion criteria (8 listed)
- Pregnant or breast-feeding women.
- Current respiratory disorders other than COPD (e.g., bronchiectasis, bronchial asthma, tuberculosis, lung fibrosis, pulmonary thromboembolic, diffuse panbronchiolitis, lung cancer).
- 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).
- Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
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 2017 GOLD, patients will be divided into Group A, B, C, and D based on individualized assessment. Salbutamol will be used to Group A patients: Salbutamol (Ventolin®, GlaxoSmithKline) 100μg/dose. 100 μg each time (when needed), and the maximum dose is 8-12 inhalations a day. | Drug | BL capsule + conventional medicine, YCC capsule+conventional medicine |
| Tiotropium Bromide (Spiriva®)Also: Group B and C patients: Tiotropium Bromide (Spiriva®)Tiotropium Bromide Powder for Inhalation will be used to Group B and Group C patients: Tiotropium Bromide Powder for Inhalation(Spiriva®, Boehringer Ingelheim), 18μg/ capsule, 10 capsules. 18μg each time, once daily. | Drug | BL capsule + conventional medicine, YCC capsule+conventional medicine |
| Salmeterol / fluticasone (Seretide®)Also: Group D patients: Salmeterol / fluticasone (Seretide®)Salmeterol / fluticasone will be used to Group D patients: Salmeterol / fluticasone (Seretide®, GlaxoSmithKline), 50/250 μg / dose, 60 inhalations. 50/250 μg each time, twice daily. | Drug | BL capsule + conventional medicine, YCC capsule+conventional medicine |
| YCC capsuleAccording to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given Yong Chong Cao (YCC)capsule (Kecai®, Guangdong daguang pharmaceutical group Co., Ltd), 1 g each time, three times a day. | Drug | YCC capsule+conventional medicine |
| BL capsuleAccording to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given Bailing(BL) capsule (Bailing®, Huadong Medicine Co.,Ltd), 1 g each time, three times a day | Drug | BL capsule + conventional medicine |
Primary outcome
The frequency of exacerbation of COPD
Time frame: Changes in the frequency of exacerbation at the week 12 and week 24 of the treatment phase, and at the week 24 of the follow-up phase compared with baseline.
The exacerbation of COPD often results in reduced quality of life, increased rate of lung function decline, increased hospitalization. It is important to assess the changes of exacerbations over time.
6 secondary outcomes
Changes in Modified Medical Research Council scale scores
Time frame: Changes in the mMRC scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.
Changes in Forced expiratory volume in one second
Time frame: Changes in FEV1 at the week 24 of the treatment phase and the week 24 of the follow-up phase compared with baseline.
Changes in COPD Assessment Test scores
Time frame: Changes in the CAT scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.
Changes in Six Minutes Walking Distance
Time frame: Changes in the 6WMD scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.
Changes in St Georges respiratory questionnaire scores
Time frame: Changes in the SGRQ scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.
Changes in clinical COPD questionnaire scores
Time frame: Changes in the CCQ scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2018.
- Derived from this study: PubMed 41295088Li S, Xie Y, Lin L, Wu L, Yu X, Ma Z, Yin Q. The Effectiveness of Yong Chong Cao Capsule in Patients With Mild to Severe COPD: A Multi-Center, Randomized, Active-Controlled Trial. J Evid Based Med. 2025 Dec;18(4):e70091. doi: 10.1111/jebm.70091. Epub 2025 Nov 26.
- Individual participant dataSharing planned: No
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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.
Suyun Li, Doctor principal investigator
The First Affiliated Hospital of HUCM
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®), Tiotropium Bromide (Spiriva®) 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 5 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 19 Nov 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 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 Jiajia Wang, Master (+86 371 66248624, wangiahn@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 of COPD (time frame: Changes in the frequency of exacerbation at the week 12 and week 24 of the treatment phase, and at the week 24 of the follow-up phase compared with baseline.). 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 NCT03745261, 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 Nov 2018.