Hypercapnic Respiratory FailurePhase 3NCT00429156
Non-invasive Ventilation Versus Sham Ventilation in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Home non-invasive ventilation in people with Hypercapnic Respiratory Failure and Chronic Obstructive Pulmonary Disease, run by United Christian Hospital at 1 site in Hong Kong.
Trial summary
The investigators hypothesize that continuation of non-invasive ventilation (NIV) at home after an episode of acute hypercapnic respiratory failure (AHRF) treated by NIV in COPD patients would reduce the likelihood of death and recurrent AHRF requiring NIV or intubation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Home non-invasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteHong Kong
- Study dates
- Jan 2007to Feb 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patient with AHRF who survives after treatment with NIV and successfully weaned off for at least 48 hours.
- Patients who have been intubated and mechanically ventilated can be included if they have also been treated with NIV in the same hospital admission
- Significant obstructive sleep apnoea ruled out by overnight polysomnography done after successful weaning of NIV (Apnoea-hypopnoea index, AHI, < 10/hr
- Patients willing to give their written informed consent to participate in the study
- Patients understand that he/she would be randomised into receiving home NIV or sham ventilation
- Patients who are able to use the home pressure support ventilators after a period of acclimatisation and training before discharge from the hospital
Who cannot join
- Patients with non-COPD causes of AHRF (e.g. asthma, bronchiectasis or lobar pneumonia, fibrothorax, acute pulmonary oedema, etc)
- Patients who have contraindications to NIV and those who refused or failed NIV during an initial 15-minute acclimatization period
- Active smoker
- An increase of ≥ 15% in FEV1 after inhaled salbutamol (200μg)
- Obstructive sleep apnoea (OSA) with apnoea-hypopnoea index (AHI) of ≥ 10/hr
- Other significant co-morbid conditions that in the investigators' view, would confer an adverse prognosis during the study period, e.g., congestive heart failure, uncontrolled diabetes mellitus, tuberculosis, neoplasms, peripheral vascular disease threatening organ functions
- Adverse psycho-social circumstances not conducive to home NIV treatment (Appendix 2)
- On long-term systemic steroid (prednisolone ≥ 7.5 mg per day for ≥ 3 months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial of Continuation of Home Non-invasive Ventilation vs Sham Ventilation in Survivors of Acute Hypercapnic Respiratory Failure in Chronic Obstructive Pulmonary Disease
The investigators hypothesize that continuation of non-invasive ventilation (NIV) at home after an episode of acute hypercapnic respiratory failure (AHRF) treated by NIV in COPD patients would reduce the likelihood of death and recurrent AHRF requiring NIV or intubation. The investigators designed this study in a way that recruited COPD patients would be started on home NIV or sham treatment after an episode of AHRF requiring acute NIV. The patients are acclimatised to NIV application after a few days of acute use. The investigators chose occurrence of life-threatening event (recurrent AHRF and death) as the primary endpoint.
Read the detailed description
Non-invasive ventilation (NIV) has been shown in randomised controlled trials to improve arterial blood gases, reduce intubation and mortality rates in patients suffering from exacerbations of chronic obstructive pulmonary disease (COPD) complicated by acute hypercapnic respiratory failure (AHRF) [1-7]. Despite success of NIV in AHRF of COPD, survivors of this group of patients might suffer from further episodes of AHRF after discharge. It has been found in a recent study that COPD patients who survived AHRF after treatment with acute NIV had a high risk of readmission and life-threatening events in the ensuing year [8]. At one year after discharge, 80% had been readmitted for respiratory diagnoses, 63% had another life-threatening event and 49% had died, mainly due to respiratory failure. Survivors spent a median of 12% time hospitalized in the subsequent year. A significant proportion of survivors required repeated NIV for recurrent AHRF. Another study showed that in COPD patients who declined intubation for AHRF and were treated with acute NIV, these outcomes were even worse, with a 1-year survival of only 30% [9]. It becomes imperative to find ways to reduce the occurrence of life-threatening events in the survivors.
There has been uncontrolled data to suggest that home NIV might reduce both hospital admissions and clinic visits in severe COPD with hypercapnic respiratory failure. In 11 severe stable COPD patients with chronic hypercapnia who did not respond to conventional treatment, Jones et al put them on home NIV [10]. Hospital admissions and clinic visits were halved in the subsequent year, together with a sustained improvement in arterial blood gases. Cost saving was demonstrated with home NIV in severe COPD in another study [11]. However, results from randomized controlled studies (RCTs) are conflicting. Three early studies suggested that home NIV was not superior to standard treatment in stable severe COPD [12, 13, 14]. On the other hand, Meecham-Jones et al found that NIV with long term oxygen therapy (LTOT) significantly improved daytime blood gases, nocturnal gas exchange and sleep quality in severe COPD [15]. A long-term RCT on home NIV in severe COPD showed that home NIV significantly reduced dyspnoea ratings, improved psychomotor coordination and decreased hospital admissions at 3 month, though reduction in hospital admissions was no longer evident by 12 months [16]. However, these randomized studies have been criticized for including chronic stable COPD patients who were not hypercapnic enough to benefit from home NIV, using inadequate inflation pressures, inadequate patient acclimatization time and not selecting the optimal outcome variables [17]. In the most recent RCT [18], home NIV with LTOT was shown to significantly improve gas exchange, dyspnoea score and quality of life; there was also a trend to reduced hospital and ICU admissions. However, the study was only powered to detect improvement in daytime PaCO2 in the NIV group.
We hypothesize that continuation of NIV at home after an episode of AHRF treated by NIV in COPD patients would reduce the likelihood of death and recurrent AHRF requiring NIV or intubation. We design this study in a way that recruited COPD patients would be started on home NIV or sham treatment after an episode of AHRF requiring acute NIV. The patients are acclimatised to NIV application after a few days of acute use. We choose occurrence of life-threatening event (recurrent AHRF and death) as the primary endpoint.
- Being tested
- Home non-invasive ventilation, Home non-invasive ventilation (sham)
- Keywords
- Non-invasive ventilation, Non-invasive positive pressure ventilation, Home ventilation, Domiciliary ventilation, Chronic obstructive pulmonary disease, COPD, Respiratory failure, Acute hypercapnic respiratory failure, NIV, NIPPV, Type II respiratory failure
- Medical subject headings
- Respiratory Insufficiency, Pulmonary Disease, Chronic Obstructive, Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home non-invasive ventilationDevice
Also called BiPAP Synchrony® (Respironics Inc., Murrysville, PA)
Continuation of home non-invasive ventilation after acute NIV for AHRF in COPD. Daily nocturnal treatment by home NIV for 1 year.
Home non-invasive ventilation (sham)Device
Also called BiPAP Synchrony® (Respironics Inc., Murrysville, PA)
Continuation of home non-invasive ventilation after acute NIV for AHRF in COPD. Daily nocturnal treatment by home sham NIV (CPAP 5 cm H2O) for 1 year.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Home non-invasive ventilation Receives: Device: Home non-invasive ventilation |
| 2 | Sham comparator | Home sham non-invasive ventilation with CPAP 5 cm H2O Receives: Device: Home non-invasive ventilation (sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first life-threatening event (recurrent AHRF and death) within the first year of hospital discharge, after an episode of AHRF treated by acute NIV.
Measured: 1 year
Secondary outcomes (6)
Withdrawal from study
Measured: 1 year
Number of readmissions
Measured: 1 year
NIV use
Measured: 1 year
Intubation
Measured: 1 year
Hospitalised days
Measured: 1 year
Blood gases levels in the first year after discharge
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionFeb 2009
- Study completionFeb 2009
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 Hypercapnic Respiratory FailureStudies 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
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- United Christian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Respironics, The Hong Kong Lung Foundation
- Investigators
- Chung-Ming Chu, MD, Principal investigator, United Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00429156
- Sponsor's protocol ID
- KC/KE 06-0147/FR-1
- Status last verified
- Oct 2009
- First submitted
- 30 Jan 2007
- Last updated
- 23 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bott L,et al.Lancet 1993;341:1555-7. Brochard L,et al.N Engl J Med 1995;333:817-22. Kramer N,et al.Am J Respir Crit Care Med 1995;151:1799-806. Angus RM,et al.Thorax 1996;51:1048-50. Celikel T,et al.Chest 1998;114:1636-42. Martin TJ,et al.Am J Respir Care Med 2000;161:807-13. Plant PK, Owen JL, Elliot MW.Lancet 2000;355:1931-5. Chu CM,et al.Thorax 2004;59:1020-1025. Chu CM,et al.Crit Care Med 2004;32:372-377.Jones SE, et al.Thorax 1998;53:495-498. Tuggey JM, Plant PK, Elliott MW.Thorax 2003;58:867-871. Strumpf DA,et al.Am Rev Respir Dis 1991;144:1234-1239. Lin CC.Am J Respir Crit Care Med 1996;154:353-358. Gay PC, Hubmayr RD, Stroetz RW.Mayo Clin Proc 1996;71:533-542. Meecham Jones DJ,et al.Am J Respir Crit Care Med 1995;152:538-44. Casanova C,et al.Chest 2000;118:1582-1590. Elliot MW, Hill NS.In Hill NS (ed.)Noninvasive positive pressure ventilation:principles and applications. Futura Publishing Company, Inv., New York, 2001;145-168. Clini E,et al.Eur Respir J 2002;20:529-538. Celli BR, MacNee W, ATS/ERS Task Force. Eur Respor J 2004;23:932-46. Mehta S, Hill NS.Am J Respir Crit Care Med 2001;163:540-577. Medical Research Council Working Party.Lancet 1981;1:681-686. Krachman SL, Quaranta AJ, Berger TJ, Criner GJ.Chest 1997;112:623-28. Fletcher CM (Chairman).BMJ 1960;2:1665. Katz S, Akpom CA. Med Care 1976;14(5 Suppl):116-8. Charlson ME, Pompei P, Ales KL, MacKenzie CR. J Chron Dis 1987;40:373-383. Knaus WA,et al.Crit Care Med 1985;13:818-29. Vitacca M,et al. Intensive Care Med 1993;19:450-5.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Continuation of Home Non-invasive Ventilation vs Sham Ventilation in Survivors of Acute Hypercapnic Respiratory Failure in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00429156
- Acronym / sponsor ID
- KC/KE 06-0147/FR-1
- Keywords
- Non-invasive ventilation, Non-invasive positive pressure ventilation, Home ventilation, Domiciliary ventilation, Chronic obstructive pulmonary disease, COPD, Respiratory failure, Acute hypercapnic respiratory failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- United Christian HospitalUniversity, hospital or other
- Collaborators
- Philips Respironics, The Hong Kong Lung Foundation
- Study start
- Jan 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 31 Jan 2007 (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 investigators hypothesize that continuation of non-invasive ventilation (NIV) at home after an episode of acute hypercapnic respiratory failure (AHRF) treated by NIV in COPD patients would reduce the likelihood of death and recurrent AHRF requiring NIV or intubation. The investigators designed this study in a way that recruited COPD patients would be started on home NIV or sham treatment after an episode of AHRF requiring acute NIV. The patients are acclimatised to NIV application after a few days of acute use. The investigators chose occurrence of life-threatening event (recurrent AHRF and death) as the primary endpoint.
Detailed description
Non-invasive ventilation (NIV) has been shown in randomised controlled trials to improve arterial blood gases, reduce intubation and mortality rates in patients suffering from exacerbations of chronic obstructive pulmonary disease (COPD) complicated by acute hypercapnic respiratory failure (AHRF) [1-7]. Despite success of NIV in AHRF of COPD, survivors of this group of patients might suffer from further episodes of AHRF after discharge. It has been found in a recent study that COPD patients who survived AHRF after treatment with acute NIV had a high risk of readmission and life-threatening events in the ensuing year [8]. At one year after discharge, 80% had been readmitted for respiratory diagnoses, 63% had another life-threatening event and 49% had died, mainly due to respiratory failure. Survivors spent a median of 12% time hospitalized in the subsequent year. A significant proportion of survivors required repeated NIV for recurrent AHRF. Another study showed that in COPD patients who declined intubation for AHRF and were treated with acute NIV, these outcomes were even worse, with a 1-year survival of only 30% [9]. It becomes imperative to find ways to reduce the occurrence of life-threatening events in the survivors.
There has been uncontrolled data to suggest that home NIV might reduce both hospital admissions and clinic visits in severe COPD with hypercapnic respiratory failure. In 11 severe stable COPD patients with chronic hypercapnia who did not respond to conventional treatment, Jones et al put them on home NIV [10]. Hospital admissions and clinic visits were halved in the subsequent year, together with a sustained improvement in arterial blood gases. Cost saving was demonstrated with home NIV in severe COPD in another study [11]. However, results from randomized controlled studies (RCTs) are conflicting. Three early studies suggested that home NIV was not superior to standard treatment in stable severe COPD [12, 13, 14]. On the other hand, Meecham-Jones et al found that NIV with long term oxygen therapy (LTOT) significantly improved daytime blood gases, nocturnal gas exchange and sleep quality in severe COPD [15]. A long-term RCT on home NIV in severe COPD showed that home NIV significantly reduced dyspnoea ratings, improved psychomotor coordination and decreased hospital admissions at 3 month, though reduction in hospital admissions was no longer evident by 12 months [16]. However, these randomized studies have been criticized for including chronic stable COPD patients who were not hypercapnic enough to benefit from home NIV, using inadequate inflation pressures, inadequate patient acclimatization time and not selecting the optimal outcome variables [17]. In the most recent RCT [18], home NIV with LTOT was shown to significantly improve gas exchange, dyspnoea score and quality of life; there was also a trend to reduced hospital and ICU admissions. However, the study was only powered to detect improvement in daytime PaCO2 in the NIV group.
We hypothesize that continuation of NIV at home after an episode of AHRF treated by NIV in COPD patients would reduce the likelihood of death and recurrent AHRF requiring NIV or intubation. We design this study in a way that recruited COPD patients would be started on home NIV or sham treatment after an episode of AHRF requiring acute NIV. The patients are acclimatised to NIV application after a few days of acute use. We choose occurrence of life-threatening event (recurrent AHRF and death) as the primary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Home non-invasive ventilationHome non-invasive ventilation |
| 2 | Sham comparator | Device: Home non-invasive ventilation (sham)Home sham non-invasive ventilation with CPAP 5 cm H2O |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- COPD patient with AHRF who survives after treatment with NIV and successfully weaned off for at least 48 hours.
- Patients who have been intubated and mechanically ventilated can be included if they have also been treated with NIV in the same hospital admission
- Significant obstructive sleep apnoea ruled out by overnight polysomnography done after successful weaning of NIV (Apnoea-hypopnoea index, AHI, < 10/hr
- Patients willing to give their written informed consent to participate in the study
- Patients understand that he/she would be randomised into receiving home NIV or sham ventilation
Key exclusion criteria (8 listed)
- Patients with non-COPD causes of AHRF (e.g. asthma, bronchiectasis or lobar pneumonia, fibrothorax, acute pulmonary oedema, etc)
- Patients who have contraindications to NIV and those who refused or failed NIV during an initial 15-minute acclimatization period
- Active smoker
- An increase of ≥ 15% in FEV1 after inhaled salbutamol (200μg)
- Obstructive sleep apnoea (OSA) with apnoea-hypopnoea index (AHI) of ≥ 10/hr
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 |
|---|---|---|
| Home non-invasive ventilationAlso: BiPAP Synchrony® (Respironics Inc., Murrysville, PA)Continuation of home non-invasive ventilation after acute NIV for AHRF in COPD. Daily nocturnal treatment by home NIV for 1 year. | Device | 1 |
| Home non-invasive ventilation (sham)Also: BiPAP Synchrony® (Respironics Inc., Murrysville, PA)Continuation of home non-invasive ventilation after acute NIV for AHRF in COPD. Daily nocturnal treatment by home sham NIV (CPAP 5 cm H2O) for 1 year. | Device | 2 |
Primary outcome
Time to first life-threatening event (recurrent AHRF and death) within the first year of hospital discharge, after an episode of AHRF treated by acute NIV.
Time frame: 1 year
6 secondary outcomes
Withdrawal from study
Time frame: 1 year
Number of readmissions
Time frame: 1 year
NIV use
Time frame: 1 year
Intubation
Time frame: 1 year
Hospitalised days
Time frame: 1 year
Blood gases levels in the first year after discharge
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2009.
- BackgroundBott L,et al.Lancet 1993;341:1555-7. Brochard L,et al.N Engl J Med 1995;333:817-22. Kramer N,et al.Am J Respir Crit Care Med 1995;151:1799-806. Angus RM,et al.Thorax 1996;51:1048-50. Celikel T,et al.Chest 1998;114:1636-42. Martin TJ,et al.Am J Respir Care Med 2000;161:807-13. Plant PK, Owen JL, Elliot MW.Lancet 2000;355:1931-5. Chu CM,et al.Thorax 2004;59:1020-1025. Chu CM,et al.Crit Care Med 2004;32:372-377.Jones SE, et al.Thorax 1998;53:495-498. Tuggey JM, Plant PK, Elliott MW.Thorax 2003;58:867-871. Strumpf DA,et al.Am Rev Respir Dis 1991;144:1234-1239. Lin CC.Am J Respir Crit Care Med 1996;154:353-358. Gay PC, Hubmayr RD, Stroetz RW.Mayo Clin Proc 1996;71:533-542. Meecham Jones DJ,et al.Am J Respir Crit Care Med 1995;152:538-44. Casanova C,et al.Chest 2000;118:1582-1590. Elliot MW, Hill NS.In Hill NS (ed.)Noninvasive positive pressure ventilation:principles and applications. Futura Publishing Company, Inv., New York, 2001;145-168. Clini E,et al.Eur Respir J 2002;20:529-538. Celli BR, MacNee W, ATS/ERS Task Force. Eur Respor J 2004;23:932-46. Mehta S, Hill NS.Am J Respir Crit Care Med 2001;163:540-577. Medical Research Council Working Party.Lancet 1981;1:681-686. Krachman SL, Quaranta AJ, Berger TJ, Criner GJ.Chest 1997;112:623-28. Fletcher CM (Chairman).BMJ 1960;2:1665. Katz S, Akpom CA. Med Care 1976;14(5 Suppl):116-8. Charlson ME, Pompei P, Ales KL, MacKenzie CR. J Chron Dis 1987;40:373-383. Knaus WA,et al.Crit Care Med 1985;13:818-29. Vitacca M,et al. Intensive Care Med 1993;19:450-5.
Related trials for Hypercapnic Respiratory Failure
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Not yet recruitingObservational study
Effectiveness and Efficiency of Home Telemonitoring and Non-invasive Ventilation in Patients With COPD and Hypercapnia (EVALECO)
Pulmonary Disease, Chronic Obstructive (COPD), Hypercapnia
Recruiting
Bedside Spirometry for Acute Lung Injury
Respiratory Insufficiency
Recruiting
Role of HFNC During FOB in Patients With Respiratory Failure
Respiratory Failure, Respiratory Failure With Hypercapnia
RecruitingObservational study
RESET-COPD Cohort: Real-Time Monitoring and Early Warning in COPD Patients Receiving Home NPPV
Pulmonary Disease, Chronic Obstructive (COPD), Chronic Respiratory Failure With Hypercapnia
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.
Chung-Ming Chu, MD principal investigator
United Christian Hospital
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 Home non-invasive ventilation in people with Hypercapnic Respiratory Failure and Chronic Obstructive Pulmonary Disease, run by United Christian Hospital at 1 site in Hong Kong.
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 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: finished, as of the sponsor's last update on 23 Oct 2009. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to first life-threatening event (recurrent AHRF and death) within the first year of hospital discharge, after an episode of AHRF treated by acute NIV. (time frame: 1 year). 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 NCT00429156, 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 23 Oct 2009.