EmphysemaPhase 3EASENCT00391612
EASE Trial: Exhale Airway Stents for Emphysema
A Phase 3 study testing Exhale® Drug-Eluting Stent in people with Emphysema, run by Broncus Technologies at 37 sites in 10 countries.
Trial summary
This is an international clinical research study evaluating the safety and effectiveness of a new procedure called airway bypass. The goal of this research is to see if airway bypass can relieve hyperinflation (overfilling) of the lungs, thereby improving lung function and reducing shortness of breath in patients with… Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Emphysema
- What is being tested?
- Exhale® Drug-Eluting Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 37 sitesin 10 countries
- Study dates
- May 2006to Dec 2013
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High resolution computed tomography (CT) scan evidence of homogeneous emphysema.
- Stopped smoking at least 8 weeks before entering the trial.
- Post-bronchodilator RV/TLC ≥ 0.65.
- Post-bronchodilator Forced Expiratory Volume (FEV1) ≤ 50% or FEV1 < 1 liter.
- Marked dyspnea, scoring ≥ 2 on the modified Medical Research Council scale of 0-4.
- Patient has undergone supervised pulmonary rehabilitation of 16-20 sessions over 6-10 weeks.
Who cannot join
- Change in FEV1 > 20% pre- and post- bronchodilator measurements or > 200 ml if post-bronchodilator FEV1 < 1 liter.
- Respiratory infections requiring 3 or more hospitalizations in past year.
- Inability to walk > 140 meters (150 yards) in 6 minutes.
- Previous lung volume reduction surgery (LVRS) or lobectomy.
Trial locations and contacts
37 sites in 10 countries.
37 sites in 10 countries
United States26 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory Healthcare
Atlanta, Georgia, 30322
Pulmonary and Critical Care Associates of Baltimore
Baltimore, Maryland, 21237
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
New York Methodist Hospital
Brooklyn, New York, 11215
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
National Jewish Medical and Research Center
Denver, Colorado, 80206
Henry Ford Hospital & Medical Center
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
UCSF-Fresno
Fresno, California, 93701
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Southern California
Los Angeles, California, 90033
Cedars-Sinai Medical Center
Los Angeles, California, 90048
International Heart Institute of Montana Foundation
Missoula, Montana, 59802
New York University - Bellevue Hospital
New York, New York, 10016
Columbia University Medical Center
New York, New York, 10032
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507
Peoria Pulmonary Associates, LTD
Peoria, Illinois, 61603
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Pulmonary Associates, PA
Phoenix, Arizona, 85006
Mayo Clinic
Rochester, Minnesota, 55905
University of California, Davis Medical Center
Sacramento, California, 95817
Sarasota Memorial Health Care System
Sarasota, Florida, 34239
Southern Illinois University School of Medicine
Springfield, Illinois, 62781
Topeka Pulmonary/Veritas Clinical Specialties, LTD
Topeka, Kansas, 66606
Chicago Chest Center at Central DuPage Hospital
Winfield, Illinois, 60190
Canada2 sites
London Health Sciences Centre
London, Ontario, N6A 4G5
Hopital Laval
Québec, Quebec, G1V 4G5
United Kingdom2 sites
Papworth Hospital
Cambridge, CB23 3RE
The Royal Brompton Hospital
London, SW3 6NP
About this study
Official title: A Randomized, Double-blind Study to Evaluate the Safety and Effectiveness of the Exhale® Drug-Eluting Stent in Homogeneous Emphysema Subjects With Severe Hyperinflation
This is an international clinical research study evaluating the safety and effectiveness of a new procedure called airway bypass. The goal of this research is to see if airway bypass can relieve hyperinflation (overfilling) of the lungs, thereby improving lung function and reducing shortness of breath in patients with severe homogeneous (diffuse) emphysema. "EASE" stands for Exhale Airway Stents for Emphysema.
Read the detailed description
Over 3 million people in the United States and tens of millions more throughout the world live with emphysema, a chronic, progressive, irreversible disease of the lungs. The hallmark of emphysema is hyperinflation of the lungs -- air is trapped in the lungs and cannot escape, causing the lungs to become larger and larger. This makes it difficult to breathe and dyspnea (shortness of breath) is the result.
The airway bypass procedure is performed using a bronchoscope with the patient under anesthesia. Very small passageways are created between the damaged lung tissue and the larger breathing passages (airways). Small stents are inserted to keep the new pathways from closing. These pathways could potentially provide a way for the trapped air to escape when the patient exhales. If the amount of air trapped in the lungs is reduced then it should be easier for the person to breathe.
The EASE study will compare the effects of Exhale Drug-Eluting Stents in patients to a sham-control group of patients who do not receive the stents. Two out of three (2/3) of the participants in the trial will be in the airway bypass group, or "treatment" group. Participants in the treatment group will undergo the airway bypass procedure with up to six drug-eluting stents implanted in their lungs, creating the passageways for the trapped air to escape. A smaller group - one out of three (1/3) participants - will be the "control" group. The control group will have bronchoscopy, but passages will not be made and stents will not be implanted.
Participants will need to return to the study center four times during the year for follow-up visits and tests. All participants will be told which group they were in when they come back for a follow-up visit one year after the procedure. Participants in the control group will be finished with the trial after one year. Participants in the treatment group will have a follow-up visit once a year for the next four years to monitor the longer term effects of the airway bypass procedure. This is why the end date of the trial is listed as 2012.
- Conditions
- Emphysema
- Being tested
- Exhale® Drug-Eluting Stent, Sham control
- Keywords
- COPD (Chronic Obstructive Pulmonary Disease), Emphysema, Hyperinflation, Minimally Invasive
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exhale® Drug-Eluting StentDevice
Bronchoscopic procedure in which up to six Exhale Drug-Eluting Stents are placed in the lungs; total procedure time is 1 to 2 hours
Sham controlDevice
5-10 minute bronchoscopic procedure in which the lungs are examined and a bronchial lavage is performed; the bronchoscope is then retracted to a point above the carina and below the vocal folds for the remained of the time; total procedure time is about 1-2 hours
| Study group | Role | What they receive |
|---|---|---|
| 2 | Sham comparator | subject receives optimal medical management, supervised pulmonary rehabilitation therapy and undergoes bronchoscopy but no stents are placed Receives: Device: Sham control |
| 1 | Experimental | subject receives optimal medical management, supervised pulmonary rehabilitation therapy and undergoes bronchoscopy during which up to six Exhale drug-eluting stents are placed in the lungs Receives: Device: Exhale® Drug-Eluting Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity (FVC)
Measured: 6 months
modified Medical Research Council (mMRC) score (breathlessness)
Measured: 6 months
Secondary outcomes (9)
Residual Volume/Total Lung Capacity (RV/TLC)
Measured: 6 months
Forced Vital Capacity (FVC)
Measured: 6 months
modified Medical Research Council Dyspnea Scale (mMRC)
Measured: 6 months
Forced Expiratory Volume in 1 second (FEV1)
Measured: 6 months
St. George's Respiratory Questionnaire (SGRQ)
Measured: 6 months
6-minute walk (6MW)
Measured: 6 months
Cycle Ergometry
Measured: 6 months
Note: Residual Volume/Total Lung Capacity (RV/TLC) will be analyzed for superiority. All other secondary endpoints will be analyzed for informational purposes.
Measured: 6 months
Residual Volume (RV)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2006 (estimated)
- Study startMay 2006
- Primary completionOct 2009 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for EmphysemaStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Broncus Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joel D. Cooper, MD, FACS, FRCS, Principal investigatorGerhard W. Sybrecht, Prof. Dr. med., Principal investigator, Universitätskliniken des Saarlandes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391612
- Sponsor's protocol ID
- Protocol 30
- Acronym
- EASE
- Status last verified
- Jan 2011
- First submitted
- 20 Oct 2006
- Last updated
- 12 Jan 2011
- Results posted
- No
Publications
Lausberg HF, Chino K, Patterson GA, Meyers BF, Toeniskoetter PD, Cooper JD. Bronchial fenestration improves expiratory flow in emphysematous human lungs. Ann Thorac Surg. 2003 Feb;75(2):393-7; discussion 398. doi: 10.1016/s0003-4975(02)04553-8.
PubMed 12607646Rendina EA, De Giacomo T, Venuta F, Coloni GF, Meyers BF, Patterson GA, Cooper JD. Feasibility and safety of the airway bypass procedure for patients with emphysema. J Thorac Cardiovasc Surg. 2003 Jun;125(6):1294-9. doi: 10.1016/s0022-5223(02)73243-1.
PubMed 12830047Choong CK, Haddad FJ, Gee EY, Cooper JD. Feasibility and safety of airway bypass stent placement and influence of topical mitomycin C on stent patency. J Thorac Cardiovasc Surg. 2005 Mar;129(3):632-8. doi: 10.1016/j.jtcvs.2004.07.062.
PubMed 15746748Choong CK, Phan L, Massetti P, Haddad FJ, Martinez C, Roschak E, Cooper JD. Prolongation of patency of airway bypass stents with use of drug-eluting stents. J Thorac Cardiovasc Surg. 2006 Jan;131(1):60-4. doi: 10.1016/j.jtcvs.2005.07.057. Epub 2005 Dec 5.
PubMed 16399295Terry PB, Traystman RJ, Newball HH, Batra G, Menkes HA. Collateral ventilation in man. N Engl J Med. 1978 Jan 5;298(1):10-5. doi: 10.1056/NEJM197801052980103.
PubMed 618444Macklem PT. Collateral ventilation. N Engl J Med. 1978 Jan 5;298(1):49-50. doi: 10.1056/NEJM197801052980112. No abstract available.
PubMed 618452Choong CK, Macklem PT, Pierce JA, Lefrak SS, Woods JC, Conradi MS, Yablonskiy DA, Hogg JC, Chino K, Cooper JD. Transpleural ventilation of explanted human lungs. Thorax. 2007 Jul;62(7):623-30. doi: 10.1136/thx.2005.053256. Epub 2007 Apr 5.
PubMed 17412776Cardoso PF, Snell GI, Hopkins P, Sybrecht GW, Stamatis G, Ng AW, Eng P. Clinical application of airway bypass with paclitaxel-eluting stents: early results. J Thorac Cardiovasc Surg. 2007 Oct;134(4):974-81. doi: 10.1016/j.jtcvs.2007.05.040. Epub 2007 Aug 20.
PubMed 17903516Shah PL, Slebos DJ, Cardoso PF, Cetti E, Voelker K, Levine B, Russell ME, Goldin J, Brown M, Cooper JD, Sybrecht GW; EASE trial study group. Bronchoscopic lung-volume reduction with Exhale airway stents for emphysema (EASE trial): randomised, sham-controlled, multicentre trial. Lancet. 2011 Sep 10;378(9795):997-1005. doi: 10.1016/S0140-6736(11)61050-7.
PubMed 21907863Shah PL, Slebos DJ, Cardoso PF, Cetti EJ, Sybrecht GW, Cooper JD. Design of the exhale airway stents for emphysema (EASE) trial: an endoscopic procedure for reducing hyperinflation. BMC Pulm Med. 2011 Jan 7;11:1. doi: 10.1186/1471-2466-11-1.
PubMed 21214899
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Study to Evaluate the Safety and Effectiveness of the Exhale® Drug-Eluting Stent in Homogeneous Emphysema Subjects With Severe Hyperinflation
- ClinicalTrials.gov ID
- NCT00391612
- Acronym / sponsor ID
- EASE / Protocol 30
- Conditions
- Emphysema
- Keywords
- COPD (Chronic Obstructive Pulmonary Disease), Emphysema, Hyperinflation, Minimally Invasive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Broncus TechnologiesIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Oct 2009 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 24 Oct 2006 (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.
This is an international clinical research study evaluating the safety and effectiveness of a new procedure called airway bypass. The goal of this research is to see if airway bypass can relieve hyperinflation (overfilling) of the lungs, thereby improving lung function and reducing shortness of breath in patients with severe homogeneous (diffuse) emphysema. "EASE" stands for Exhale Airway Stents for Emphysema.
Detailed description
Over 3 million people in the United States and tens of millions more throughout the world live with emphysema, a chronic, progressive, irreversible disease of the lungs. The hallmark of emphysema is hyperinflation of the lungs -- air is trapped in the lungs and cannot escape, causing the lungs to become larger and larger. This makes it difficult to breathe and dyspnea (shortness of breath) is the result.
The airway bypass procedure is performed using a bronchoscope with the patient under anesthesia. Very small passageways are created between the damaged lung tissue and the larger breathing passages (airways). Small stents are inserted to keep the new pathways from closing. These pathways could potentially provide a way for the trapped air to escape when the patient exhales. If the amount of air trapped in the lungs is reduced then it should be easier for the person to breathe.
The EASE study will compare the effects of Exhale Drug-Eluting Stents in patients to a sham-control group of patients who do not receive the stents. Two out of three (2/3) of the participants in the trial will be in the airway bypass group, or "treatment" group. Participants in the treatment group will undergo the airway bypass procedure with up to six drug-eluting stents implanted in their lungs, creating the passageways for the trapped air to escape. A smaller group - one out of three (1/3) participants - will be the "control" group. The control group will have bronchoscopy, but passages will not be made and stents will not be implanted.
Participants will need to return to the study center four times during the year for follow-up visits and tests. All participants will be told which group they were in when they come back for a follow-up visit one year after the procedure. Participants in the control group will be finished with the trial after one year. Participants in the treatment group will have a follow-up visit once a year for the next four years to monitor the longer term effects of the airway bypass procedure. This is why the end date of the trial is listed as 2012.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Sham comparator | Device: Sham controlsubject receives optimal medical management, supervised pulmonary rehabilitation therapy and undergoes bronchoscopy but no stents are placed |
| 1 | Experimental | Device: Exhale® Drug-Eluting Stentsubject receives optimal medical management, supervised pulmonary rehabilitation therapy and undergoes bronchoscopy during which up to six Exhale drug-eluting stents are placed in the lungs |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- High resolution computed tomography (CT) scan evidence of homogeneous emphysema.
- Stopped smoking at least 8 weeks before entering the trial.
- Post-bronchodilator RV/TLC ≥ 0.65.
- Post-bronchodilator Forced Expiratory Volume (FEV1) ≤ 50% or FEV1 < 1 liter.
- Marked dyspnea, scoring ≥ 2 on the modified Medical Research Council scale of 0-4.
Key exclusion criteria (4 listed)
- Change in FEV1 > 20% pre- and post- bronchodilator measurements or > 200 ml if post-bronchodilator FEV1 < 1 liter.
- Respiratory infections requiring 3 or more hospitalizations in past year.
- Inability to walk > 140 meters (150 yards) in 6 minutes.
- Previous lung volume reduction surgery (LVRS) or lobectomy.
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 |
|---|---|---|
| Exhale® Drug-Eluting StentBronchoscopic procedure in which up to six Exhale Drug-Eluting Stents are placed in the lungs; total procedure time is 1 to 2 hours | Device | 1 |
| Sham control5-10 minute bronchoscopic procedure in which the lungs are examined and a bronchial lavage is performed; the bronchoscope is then retracted to a point above the carina and below the vocal folds for the remained of the time; total procedure time is about 1-2 hours | Device | 2 |
Primary outcome
Forced Vital Capacity (FVC)
Time frame: 6 months
modified Medical Research Council (mMRC) score (breathlessness)
Time frame: 6 months
9 secondary outcomes
Residual Volume/Total Lung Capacity (RV/TLC)
Time frame: 6 months
Forced Vital Capacity (FVC)
Time frame: 6 months
modified Medical Research Council Dyspnea Scale (mMRC)
Time frame: 6 months
Forced Expiratory Volume in 1 second (FEV1)
Time frame: 6 months
St. George's Respiratory Questionnaire (SGRQ)
Time frame: 6 months
6-minute walk (6MW)
Time frame: 6 months
Cycle Ergometry
Time frame: 6 months
Note: Residual Volume/Total Lung Capacity (RV/TLC) will be analyzed for superiority. All other secondary endpoints will be analyzed for informational purposes.
Time frame: 6 months
Residual Volume (RV)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2011.
- Background: PubMed 12607646Lausberg HF, Chino K, Patterson GA, Meyers BF, Toeniskoetter PD, Cooper JD. Bronchial fenestration improves expiratory flow in emphysematous human lungs. Ann Thorac Surg. 2003 Feb;75(2):393-7; discussion 398. doi: 10.1016/s0003-4975(02)04553-8.
- Background: PubMed 12830047Rendina EA, De Giacomo T, Venuta F, Coloni GF, Meyers BF, Patterson GA, Cooper JD. Feasibility and safety of the airway bypass procedure for patients with emphysema. J Thorac Cardiovasc Surg. 2003 Jun;125(6):1294-9. doi: 10.1016/s0022-5223(02)73243-1.
- Background: PubMed 15746748Choong CK, Haddad FJ, Gee EY, Cooper JD. Feasibility and safety of airway bypass stent placement and influence of topical mitomycin C on stent patency. J Thorac Cardiovasc Surg. 2005 Mar;129(3):632-8. doi: 10.1016/j.jtcvs.2004.07.062.
- Background: PubMed 16399295Choong CK, Phan L, Massetti P, Haddad FJ, Martinez C, Roschak E, Cooper JD. Prolongation of patency of airway bypass stents with use of drug-eluting stents. J Thorac Cardiovasc Surg. 2006 Jan;131(1):60-4. doi: 10.1016/j.jtcvs.2005.07.057. Epub 2005 Dec 5.
- Background: PubMed 618444Terry PB, Traystman RJ, Newball HH, Batra G, Menkes HA. Collateral ventilation in man. N Engl J Med. 1978 Jan 5;298(1):10-5. doi: 10.1056/NEJM197801052980103.
- Background: PubMed 618452Macklem PT. Collateral ventilation. N Engl J Med. 1978 Jan 5;298(1):49-50. doi: 10.1056/NEJM197801052980112. No abstract available.
- Background: PubMed 17412776Choong CK, Macklem PT, Pierce JA, Lefrak SS, Woods JC, Conradi MS, Yablonskiy DA, Hogg JC, Chino K, Cooper JD. Transpleural ventilation of explanted human lungs. Thorax. 2007 Jul;62(7):623-30. doi: 10.1136/thx.2005.053256. Epub 2007 Apr 5.
- Background: PubMed 17903516Cardoso PF, Snell GI, Hopkins P, Sybrecht GW, Stamatis G, Ng AW, Eng P. Clinical application of airway bypass with paclitaxel-eluting stents: early results. J Thorac Cardiovasc Surg. 2007 Oct;134(4):974-81. doi: 10.1016/j.jtcvs.2007.05.040. Epub 2007 Aug 20.
- Derived from this study: PubMed 21907863Shah PL, Slebos DJ, Cardoso PF, Cetti E, Voelker K, Levine B, Russell ME, Goldin J, Brown M, Cooper JD, Sybrecht GW; EASE trial study group. Bronchoscopic lung-volume reduction with Exhale airway stents for emphysema (EASE trial): randomised, sham-controlled, multicentre trial. Lancet. 2011 Sep 10;378(9795):997-1005. doi: 10.1016/S0140-6736(11)61050-7.
- Derived from this study: PubMed 21214899Shah PL, Slebos DJ, Cardoso PF, Cetti EJ, Sybrecht GW, Cooper JD. Design of the exhale airway stents for emphysema (EASE) trial: an endoscopic procedure for reducing hyperinflation. BMC Pulm Med. 2011 Jan 7;11:1. doi: 10.1186/1471-2466-11-1.
- Broncus Technologies, Inc., corporate web page.Link provided by the sponsor.
- American Lung AssociationLink provided by the sponsor.
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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.
Joel D. Cooper, MD, FACS, FRCS principal investigator
Gerhard W. Sybrecht, Prof. Dr. med. principal investigator
Universitätskliniken des Saarlandes
37 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exhale® Drug-Eluting Stent in people with Emphysema, run by Broncus Technologies at 37 sites in 10 countries.
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 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: status not confirmed, as of the sponsor's last update on 12 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Canada, United Kingdom, Australia, Austria and 5 more countries. 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?
Results are not available in the source record.
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?
Forced Vital Capacity (FVC) (time frame: 6 months). The study lists 2 primary outcomes in all. 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 NCT00391612, which also lists 10 linked publications.
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 12 Jan 2011.