Chronic Obstructive Pulmonary DiseaseCOPDNCT01259245
Effectiveness of Incorporating Tai Chi in Pulmonary Rehabilitation Program for Chronic Obstructive Pulmonary Disease Patients in Primary Health Care
A study testing Tai chi + PRP and PRP in people with Chronic Obstructive Pulmonary Disease, run by Kwong Wah Hospital at 1 site in China.
Trial summary
The purpose of this study was to compare the self-efficacy and quality of life parameters of Chronic Obstructive Pulmonary Disease(COPD)patients who underwent pulmonary rehabilitation with and without Tai Chi elements incorporated in the exercise component in a General Out-patient setting. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Tai chi + PRP and PRP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- Mar 2011to May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- . Previous diagnosis of COPD
- . Absence of bronchiectasis, bronchiolitis obliterans, panbronchiolitis and asthma
- . Medical Research Council(MRC)Dyspnea score > 2 using the 1-5 scale version
- .Willing to participate and able to give consent
Who cannot join
- . Patients with poor mobility, i.e. wheelchair bound; or
- . Patients with severe comorbidities, including acute myocardial infarction in preceding 6 months; or
- . Patients with severe hearing impairment or cognitive impairment; or
- . Patient unwilling to participate and unable to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Incorporating Tai Chi in Pulmonary Rehabilitation Program for COPD Patients in Primary Health Care
The purpose of this study was to compare the self-efficacy and quality of life parameters of Chronic Obstructive Pulmonary Disease(COPD)patients who underwent pulmonary rehabilitation with and without Tai Chi elements incorporated in the exercise component in a General Out-patient setting.
Read the detailed description
Subjects: 192 patients were enrolled and recruited from four General Out-patient clinics in Yau Tsim Mong and Wong Tai Sin districts.
Study Design: Prospective single blind randomized controlled trial
Subjects were randomized into Pulmonary rehabilitation program (PRP) group (n = 98) and Pulmonary rehabilitation program with Tai chi group (TC)(n=94). Details of PRP and PRP + Tai Chi will be discussed below.
Both groups will be given booklet on COPD information and management.
Randomization:
Computer generated pre-assigned randomization of subjects to group allocation is made after baseline assessment. At each stage, assessors for outcome measures and data collection are blinded to the patient's grouping. Patients, investigator and physiotherapist are open to the group allocation.
Standardized medical treatment:
All COPD patients are managed according to practical guidelines recommended by the Hospital Authority. Medical treatment is reviewed and changed if clinically appropriate. In response to an exacerbation, antibiotic is added if a respiratory infection is the cause and oral steroid may be prescribed if clinically indicated.
Measurement and Evaluation
Baseline assessment:
- Medical aspect: GOLD staging of COPD; Baseline spirometry test including bronchodilator reversibility test.
- Self-Efficacy: COPD Self Efficacy Scale (CSES); Self-Efficacy for Managing Shortness of Breath (SEMSOB)
- Quality of life related measures: St. George Respiratory Questionnaire ( SGRQ)
- Exercise Capacity: 6 Minutes Walking Distance Test (6MWT)
Reassessment done at 2 months and 6 months using:
- Primary Outcome measures and Secondary measures outcome mentioned in outcome measures
- Spirometry exclusive of bronchodilator reversibility test
Statistical methods
Descriptive statistics including mean, standard deviation, frequency and percentages were used to describe the demographic characteristics and summarize the baseline characteristics of the variables. Independent T-test was used to examine the difference in demographic characteristics and baseline outcome measures between the PRP and TC group. Paired T-test was performed to examine the differences of outcome measures, including spirometry, 6 MWT, SGRQ-HKC, CSES, SEMSOB before and after intervention program within group. Analysis of covariance(ANCOVA) were used to examine the differences of outcome variables between PRP and TC group adjusted for age, sex, body mass index BMI, smoking and education, with the corresponding baseline value as a covariate. A p-value of 0.05 ws used as the level of statistical significance. Confidence intervals ( 95%) of the mean differences between baseline and 6 months post intervention values were calculated to compare the effects with the minimum clinically important difference (MCID) for the SGRQ-HKC. All analyses were conducted using Statistical package for the Social Sciences SPSS version 16.0.
Pulmonary Rehabilitation Programme (PRP) Details :
The revised PRP consisted of 12 sessions (twice per week for 6 weeks) with 6-10 subjects per session. The standard content consists of physical training including warm up \& cool down exercise and aerobic exercises.
For the PRP group, patients performed 5 minutes warm up exercises. Then 2 aerobic activities including treadmill exercise and lower limb ergometry exercise lasting 20 minutes each,were prescribed. 15 minutes rest were given between each exercise. After the aerobic exercises, 5 minutes cool down exercises, followed by 15 minutes of relaxation exercise was conducted before patients completed that session. Each session lasted for about 1 hour and 20 minutes.They were instructed to continue unsupervised home exercises consisting of 5 minutes of warm-up, 5 minutes of Thera-Band strengthening exercises, 30 minutes of aerobic exercises, 5 minutes cool down and 15 minutes of relaxation exercise for at least one hour 5-7 days/week.
For the PRP + Tai Chi group, the exercise content is totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to the 15 minutes of relaxation exercise. Each session also lasted for about 1 hour and 20 minutes. The 5 forms of Suen Style of Tai Chi are chosen because it will encourage larger limbs movement as well as chest wall movement incorporated with diaphragmatic breathing and breathing control.
Details of the 5 forms of Sun Style Tai Chi chosen are:
- commencing form
- single whip : left and right
- turn with slanted flying: left and right
- wave hands like clouds: left and right
- moving as if shutting a door
The exercise intensity level of the aerobic activities will be set at a target heart rate of 60-70 % of their maximum heart rate and rate of perceived dyspnea(RPD) level of not more than 7. Vital signs will be monitored before, during \& after exercise to ensure that the exercise heart rate does not exceed the target level. Also, any time when patient feels discomfort with RPD level reaching 7, the exercise will be stopped and patient is allowed to rest.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Tai chi + PRP, PRP
- Keywords
- Chronic obstructive pulmonary disease COPD, pulmonary rehabilitation program PRP, Tai chi
- 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.
Tai chi + PRPOther
Also called Tai chi elements added to pulmonary rehabilitation program
The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise
PRPOther
Also called Formal pulmonary rehabilitation program
Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting
| Study group | Role | What they receive |
|---|---|---|
| Tai chi + PRP | Experimental | Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught. Receives: Other: Tai chi + PRP; Other: PRP |
| PRP | Active comparator | PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management. Receives: Other: PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Efficacy :COPD Self Efficacy Scale (CSES)
34 item questionnaire consisting of likert scale with 5 responses ranging from "1" indicating " not at all confident" to "5" indicating " very confident" with higher scores representing higher self efficacy. In this study , we used the rating score in the analysis as some items were considered non-applicable in some cases. Rating score from 0.2 to 1 with 0.2 as "not at all confident and 1 as "very confident". The validated Chinese version of CSES was also used
Measured: Change in CSES at 6 months post-intervention
Self- Efficacy : Self-Efficacy for Managing Shortness of Breath ( SEMSOB)
The SEMSOB is a single question 1-10 scale, valid and reliable instrument that measures patients' overall confidence in keeping breathing difficulties from interfering with what they want to do with higher score indicating greater self efficacy.
Measured: Change in SEMSOB at 6 months post-intervention
SGRQ HKC-Symptoms
SGRQ HKC-Symptoms is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-Symptoms score ranged from 0 to 100, where zero indicates best health and 100 indicating maximum disability.
Measured: 6 months post-intervention
SGRQ HKC-Activity
SGRQ HKC-Activity is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-Activity score from 0 to 100, where zero indicates best health and 100 indicating maximum disability.
Measured: 6 months post-intervention
SGRQ HKC-Impact
SGRQ HKC -Impact is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-impact score from 0 to 100, where zero indicates best health and 100 indicating maximum disability.
Measured: 6 months post-intervention
SGRQ HKC Total
SGRQ HKC-Total is calculated by summing all positive responses in the questionnaire and expressing the result as a percentage of the toal weight for the questionnaire. A total score is calculated from all three components. The SGRQ-total score ranged from 0 to 100, where zero indicates best health and 100 indicating maximum disability.
Measured: 6 months post-intervention
Secondary outcomes (4)
6 MWT in Meters
The 6 minute walking test ( 6MWT) was conducted according to protocol recommended by American Thoracic Society (ATS) guidelines to measure functional exercise capacity.This test measured the self paced distance in meters that a patient could quickly walk on a flat, hard surface in a period of 6 minutes.
Measured: 6 months post-intervention
FVC
Forced vital capacity, measured in liters, component of lung function parameters measured by spirometry
Measured: 6 months post intervention
FEV1
Forced expiratory volume in one second, measured in liters, component of lung function test measured by spirometry
Measured: 6 months post-intervention
FEV1% Pred
Pred FEV1 percent predicted normal values;measured using spirometry
Measured: 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startMar 2011
- Primary completionNov 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kwong Wah Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorna Ventura Ng, Kwong Wah Hospital
- Investigators
- lorna Ng, doctor, Principal investigator, Kwong Wah Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259245
- Sponsor's protocol ID
- HHSRF08091291
- Acronym
- COPD
- Status last verified
- Mar 2013
- First submitted
- 3 Dec 2010
- Last updated
- 5 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Incorporating Tai Chi in Pulmonary Rehabilitation Program for COPD Patients in Primary Health Care
- ClinicalTrials.gov ID
- NCT01259245
- Acronym / sponsor ID
- COPD / HHSRF08091291
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease COPD, pulmonary rehabilitation program PRP, Tai chi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Kwong Wah HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 14 Dec 2010 (estimated)
- Results
- Posted 5 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to compare the self-efficacy and quality of life parameters of Chronic Obstructive Pulmonary Disease(COPD)patients who underwent pulmonary rehabilitation with and without Tai Chi elements incorporated in the exercise component in a General Out-patient setting.
Detailed description
Subjects: 192 patients were enrolled and recruited from four General Out-patient clinics in Yau Tsim Mong and Wong Tai Sin districts.
Study Design: Prospective single blind randomized controlled trial
Subjects were randomized into Pulmonary rehabilitation program (PRP) group (n = 98) and Pulmonary rehabilitation program with Tai chi group (TC)(n=94). Details of PRP and PRP + Tai Chi will be discussed below.
Both groups will be given booklet on COPD information and management.
Randomization:
Computer generated pre-assigned randomization of subjects to group allocation is made after baseline assessment. At each stage, assessors for outcome measures and data collection are blinded to the patient's grouping. Patients, investigator and physiotherapist are open to the group allocation.
Standardized medical treatment:
All COPD patients are managed according to practical guidelines recommended by the Hospital Authority. Medical treatment is reviewed and changed if clinically appropriate. In response to an exacerbation, antibiotic is added if a respiratory infection is the cause and oral steroid may be prescribed if clinically indicated.
Measurement and Evaluation
Baseline assessment:
- Medical aspect: GOLD staging of COPD; Baseline spirometry test including bronchodilator reversibility test.
- Self-Efficacy: COPD Self Efficacy Scale (CSES); Self-Efficacy for Managing Shortness of Breath (SEMSOB)
- Quality of life related measures: St. George Respiratory Questionnaire ( SGRQ)
- Exercise Capacity: 6 Minutes Walking Distance Test (6MWT)
Reassessment done at 2 months and 6 months using:
- Primary Outcome measures and Secondary measures outcome mentioned in outcome measures
- Spirometry exclusive of bronchodilator reversibility test
Statistical methods
Descriptive statistics including mean, standard deviation, frequency and percentages were used to describe the demographic characteristics and summarize the baseline characteristics of the variables. Independent T-test was used to examine the difference in demographic characteristics and baseline outcome measures between the PRP and TC group. Paired T-test was performed to examine the differences of outcome measures, including spirometry, 6 MWT, SGRQ-HKC, CSES, SEMSOB before and after intervention program within group. Analysis of covariance(ANCOVA) were used to examine the differences of outcome variables between PRP and TC group adjusted for age, sex, body mass index BMI, smoking and education, with the corresponding baseline value as a covariate. A p-value of 0.05 ws used as the level of statistical significance. Confidence intervals ( 95%) of the mean differences between baseline and 6 months post intervention values were calculated to compare the effects with the minimum clinically important difference (MCID) for the SGRQ-HKC. All analyses were conducted using Statistical package for the Social Sciences SPSS version 16.0.
Pulmonary Rehabilitation Programme (PRP) Details :
The revised PRP consisted of 12 sessions (twice per week for 6 weeks) with 6-10 subjects per session. The standard content consists of physical training including warm up \& cool down exercise and aerobic exercises.
For the PRP group, patients performed 5 minutes warm up exercises. Then 2 aerobic activities including treadmill exercise and lower limb ergometry exercise lasting 20 minutes each,were prescribed. 15 minutes rest were given between each exercise. After the aerobic exercises, 5 minutes cool down exercises, followed by 15 minutes of relaxation exercise was conducted before patients completed that session. Each session lasted for about 1 hour and 20 minutes.They were instructed to continue unsupervised home exercises consisting of 5 minutes of warm-up, 5 minutes of Thera-Band strengthening exercises, 30 minutes of aerobic exercises, 5 minutes cool down and 15 minutes of relaxation exercise for at least one hour 5-7 days/week.
For the PRP + Tai Chi group, the exercise content is totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to the 15 minutes of relaxation exercise. Each session also lasted for about 1 hour and 20 minutes. The 5 forms of Suen Style of Tai Chi are chosen because it will encourage larger limbs movement as well as chest wall movement incorporated with diaphragmatic breathing and breathing control.
Details of the 5 forms of Sun Style Tai Chi chosen are:
- commencing form
- single whip : left and right
- turn with slanted flying: left and right
- wave hands like clouds: left and right
- moving as if shutting a door
The exercise intensity level of the aerobic activities will be set at a target heart rate of 60-70 % of their maximum heart rate and rate of perceived dyspnea(RPD) level of not more than 7. Vital signs will be monitored before, during \& after exercise to ensure that the exercise heart rate does not exceed the target level. Also, any time when patient feels discomfort with RPD level reaching 7, the exercise will be stopped and patient is allowed to rest.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai chi + PRP | Experimental | Other: Tai chi + PRP, Other: PRPTai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught. |
| PRP | Active comparator | Other: PRPPRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- . Previous diagnosis of COPD
- . Absence of bronchiectasis, bronchiolitis obliterans, panbronchiolitis and asthma
- . Medical Research Council(MRC)Dyspnea score > 2 using the 1-5 scale version
- .Willing to participate and able to give consent
Key exclusion criteria (4 listed)
- . Patients with poor mobility, i.e. wheelchair bound; or
- . Patients with severe comorbidities, including acute myocardial infarction in preceding 6 months; or
- . Patients with severe hearing impairment or cognitive impairment; or
- . Patient unwilling to participate and unable to give consent
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 |
|---|---|---|
| Tai chi + PRPAlso: Tai chi elements added to pulmonary rehabilitation programThe exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise | Other | Tai chi + PRP |
| PRPAlso: Formal pulmonary rehabilitation programFormal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting | Other | PRP, Tai chi + PRP |
Primary outcome
Self Efficacy :COPD Self Efficacy Scale (CSES)
Time frame: Change in CSES at 6 months post-intervention
34 item questionnaire consisting of likert scale with 5 responses ranging from "1" indicating " not at all confident" to "5" indicating " very confident" with higher scores representing higher self efficacy. In this study , we used the rating score in the analysis as some items were considered non-applicable in some cases. Rating score from 0.2 to 1 with 0.2 as "not at all confident and 1 as "very confident". The validated Chinese version of CSES was also used
Self- Efficacy : Self-Efficacy for Managing Shortness of Breath ( SEMSOB)
Time frame: Change in SEMSOB at 6 months post-intervention
The SEMSOB is a single question 1-10 scale, valid and reliable instrument that measures patients' overall confidence in keeping breathing difficulties from interfering with what they want to do with higher score indicating greater self efficacy.
SGRQ HKC-Symptoms
Time frame: 6 months post-intervention
SGRQ HKC-Symptoms is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-Symptoms score ranged from 0 to 100, where zero indicates best health and 100 indicating maximum disability.
SGRQ HKC-Activity
Time frame: 6 months post-intervention
SGRQ HKC-Activity is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-Activity score from 0 to 100, where zero indicates best health and 100 indicating maximum disability.
SGRQ HKC-Impact
Time frame: 6 months post-intervention
SGRQ HKC -Impact is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage. SGRQ-impact score from 0 to 100, where zero indicates best health and 100 indicating maximum disability.
SGRQ HKC Total
Time frame: 6 months post-intervention
SGRQ HKC-Total is calculated by summing all positive responses in the questionnaire and expressing the result as a percentage of the toal weight for the questionnaire. A total score is calculated from all three components. The SGRQ-total score ranged from 0 to 100, where zero indicates best health and 100 indicating maximum disability.
4 secondary outcomes
6 MWT in Meters
Time frame: 6 months post-intervention
FVC
Time frame: 6 months post intervention
FEV1
Time frame: 6 months post-intervention
FEV1% Pred
Time frame: 6 months post-intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
lorna Ng, doctor principal investigator
Kwong Wah Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai chi + PRP and PRP in people with Chronic Obstructive Pulmonary Disease, run by Kwong Wah Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 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: finished, as of the sponsor's last update on 5 Mar 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self Efficacy :COPD Self Efficacy Scale (CSES) (time frame: Change in CSES at 6 months post-intervention). The study lists 6 primary outcomes in all. 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 5 Mar 2013.