Pulmonary Disease, Chronic ObstructivePhase 3STATCOPENCT01061671
Simvastatin Therapy for Moderate and Severe COPD
A Phase 3 study testing simvastatin in people with Pulmonary Disease, Chronic Obstructive, run by University of Minnesota at 51 sites in 2 countries.
Trial summary
To determine the effect of daily administration of 40 mgms simvastatin taken for at least 12 months (range 12-36 months) on the frequency of exacerbations of chronic obstructive lung disease (COPD) in patients with moderate to severe COPD who are prone to exacerbations and do not have other indications for statin… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 885 participants
- Where
- 51 sitesin 2 countries
- Study dates
- Mar 2010to Jan 2014
- Phase
- Phase 3
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects, 40-80 years of age.
- Clinical diagnosis of at least moderate COPD as defined by the GOLD criteria:
- Postbronchodilator FEV1(forced expiratory volume at one second)/FVC(forced vital capacity) < 70%,
- Postbronchodilator FEV1 (forced expiratory volume at one second) < 80% predicted, with or without chronic symptoms (i.e., cough, sputum production).
- Cigarette consumption of 10 pack-years or more. Patients may or may not be active smokers.
- Must meet one or more of the following 4 conditions
Show all 13Show fewer
- Be using supplemental oxygenate
- Receiving a course of systemic corticosteroids and/or antibiotics for respiratory problems in the past year,
- Visiting an Emergency Department for a COPD exacerbation within the past year, or
- Being hospitalized for a COPD (Chronic Obstructive Pulmonary Disease) exacerbation within the past year
- Willingness to make return visits and availability by telephone for duration of study.
- Free of active coronary disease
- Subject with expected life expectancy > 36 months
Who cannot join
- Patients who:
- are on statin drugs.
- should be on statins based on established risk stratification using the ATP-III (Adult Treatment Panel) to determine 10 year risk.
- Documented history of active coronary heart disease, such as unstable angina, prior myocardial infarction, stroke, symptomatic peripheral vascular or carotid artery disease, or congestive heart failure within the past 3 months.
- A diagnosis of asthma.
- The presence of a diagnosis other than COPD that results in the patient being either medically unstable, or having a predicted life expectancy < 3 years.
Show all 20Show fewer
- Special patient groups: prisoners, pregnant women, institutionalized patients
- Women who are at risk of becoming pregnant during the study (pre-menopausal) and who refuse to use acceptable birth control (hormone-based oral or barrier contraceptive) for the duration of the study.
- Woman using estradiol compounds for contraception. Postmenopausal women on estradiol compounds for hormone replacement therapy will be allowed into the trial.
- Participants otherwise meeting the inclusion criteria will not be enrolled until they are a minimum of four weeks from their most recent acute exacerbation.
- A clinical diagnosis of bronchiectasis defined as production of > one-half cup of purulent sputum/day.
- Participants using niacin, azole antifungals (itraconazole, ketoconazole, posaconazole), fibric acid derivatives, erythromycin, clarithromycin, telithromycin, diltiazem, amlodipine , ranolazine,HIV protease inhibitors (such as indinavir), amiodarone, gemfibrozil, cyclosporine, verapamil, danazol, nefazodone, and red yeast rice extracts are excluded
- Active liver disease. Active liver disease is defined as ALT (alanine aminotransferase), AST (aspartate aminotransferase) as greater than 1.5 times the upper limit of normal.
- Patients with renal failure defined by serum creatinine greater than 3mg/dl.
- Alcoholism. Alcoholism is defined as > 35 drinks per week. A drink is defined as one bottle of beer, one 8-ounce glass of wine, or one ounce of hard liquor.
- Hypersensitivity to HMG CoA (3-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors. Hypersensitivity is defined as an allergic reaction to statin, prior history of myopathy, rhabdomyolysis or previous intolerance to statin use.
- Participants drinking greater than 4 cups (1qt) of grapefruit juice per day.
- Participants drinking greater than 3 cups of green tea per day.
- Diabetics will be excluded. Diabetics are defined by:
- 1. A CURRENT physician diagnosis of diabetes OR 2. CURRENT use of diabetic meds OR 3. Elevated HbA1c > 6.5% 18. The discretion of the Principal Investigator that the potential participant will not be a reliable study subject to complete the study requirements.
Trial locations and contacts
51 sites in 2 countries.
51 sites in 2 countries
United States35 sites
Lovelace Respiratory Research Institute
Albuquerque, New Mexico, 87108
Veteran's Administration Medical Center
Ann Arbor, Michigan, 48105
University of Michigan
Ann Arbor, Michigan, 48109
University of Colorado
Aurora, Colorado, 80045
University of Maryland Baltimore
Baltimore, Maryland, 21201
St. Luke's Hospital and Health Network
Bethlehem, Pennsylvania, 18015
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Veteran's Administration Medical Center
Birmingham, Alabama, 35294
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Veteran's Administration Medical Center
Boston, Massachusetts, 02132
Western New York Veterans Administration Healthcare System
Buffalo, New York, 14125
Northwestern University
Chicago, Illinois, 60611
University of Illinois Health System
Chicago, Illinois, 60637
Cincinnati VAMC
Cincinnati, Ohio, 45220
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43221
Geisinger Medical Center
Danville, Pennsylvania, 17822
National Jewish Health
Denver, Colorado, 80206
Duke University
Durham, North Carolina, 27710
Malcom Randall VA Medical Center
Gainesville, Florida, 32608
Baylor College of Medicine
Houston, Texas, 77030
Institute for Respiratory and Sleep
Langhorne, Pennsylvania, 19047
LA BioMed at Harbor-UCLA Medical Center
Los Angeles, California, 90502
Veteran's Administration Medical Center
Minneapolis, Minnesota, 55417
HealthPartners Research Foundation
Minneapolis, Minnesota, 55440
LSU Health
New Orleans, Louisiana, 70112
Temple University Lung Center
Philadelphia, Pennsylvania, 19140
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Pittsburgh VA Medical Center
Pittsburgh, Pennsylvania, 15240
Oregon Health & Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
University of California at San Francisco
San Francisco, California, 94143
Reliant Medical Group
Worcester, Massachusetts, 01608
Respiratory Specialists
Wyomissing, Pennsylvania, 19601
Canada16 sites
University of Calgary
Calgary, Alberta, T2N4Z6
University of Alberta
Edmonton, Alberta, T6G 2C8
Queen Elizabeth II Health Sciences Center
Halifax, Nova Scotia, B3H 3A7
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Royal Columbian Hospital
New Westminster, British Columbia
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Ottawa Civic Hospital
Ottawa, Ontario, K1Y4E9
Institut Universitaire de Cardiologie et de Pneumologie de Québec (Laval Hospital)
Québec, G1V 4G5
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Surrey Memorial Hospital
Surrey, British Columbia, V3V1N1
Inspiration Research Limited
Toronto, Ontario, M5T 3A9
Vancouver General Hospital
Vancouver, British Columbia, V5Z1M9
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Lion's Gate Hospital
Vancouver, British Columbia, V7M2H9
St. Boniface Hospital
Winnipeg, Manitoba, R2H2A6
About this study
Official title: Prospective Randomized Placebo-Controlled Trial of SimvaSTATin in the Prevention of COPD Exacerbations (STATCOPE)
To determine the effect of daily administration of 40 mgms simvastatin taken for at least 12 months (range 12-36 months) on the frequency of exacerbations of chronic obstructive lung disease (COPD) in patients with moderate to severe COPD who are prone to exacerbations and do not have other indications for statin treatment.
Read the detailed description
COPD exacerbation is a common complication that significantly contributes to the high morbidity, mortality and costs associated with COPD. COPD exacerbations are associated with heightened lung inflammation that may have systemic implications (e.g., peripheral muscle weakness, cognitive impairment, depression, stroke, acute coronary syndrome, and atherosclerosis). Statins are potent agents that significantly reduce vascular events in patients with increased risks due to prior cardiac or cerebral vascular events and elevated lipid profiles. Statins have pleiotropic effects that extend well beyond their lipid lowering effects and may be potent anti-inflammatory agents. Retrospective data conducted in COPD patients indicate that statin use is associated with markedly decreased rates of COPD hospitalization and stabilization of lung function. Decreases in mortality in COPD due to complications of flu-like illnesses and deaths due to cardiovascular events have also been reported. Inflammatory biomarkers (C-reactive protein and interleukin- 6) are reported to be elevated in moderate to severe COPD patients who are prone to exacerbations. Inflammatory biomarkers (C-reactive protein and interleukin- 6) are reported to be reduced by statin therapy in patients with hyperlipidemia and cardiovascular diseases. Treatments that can effectively lessen the prevalence and severity of COPD exacerbations are desperately needed
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- simvastatin, Placebo
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Exacerbation, Lung function, Cardiovascular, Smoking, Statins, Simvastatin
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simvastatinDrug
Also called Zocor
40 mgms of simvastatin daily
PlaceboDrug
Also called sugar pill
Matched placebo pill daily
| Study group | Role | What they receive |
|---|---|---|
| simvastatin | Active comparator | 40 mgms of simvastatin daily Receives: Drug: simvastatin |
| placebo | Placebo comparator | Matched placebo pill daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of COPD Exacerbations
Measured: up to 37 months
Secondary outcomes (3)
Time to First COPD Exacerbation
Measured: up to 37 months
Change in FEV1 (% Pred) From Baseline to Last Measure
Measured: Baseline, last measure at up to 37 months
Acute Exacerbation COPD Hospitalization Rates (Events/Patient Year)
Measured: up to 37 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Futility
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.
- Publications (5)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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 885 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Canadian Institutes of Health Research (CIHR), Ottawa Hospital Research Institute
- Responsible party
- Sponsor
- Investigators
- John E Connett, PhD, Principal investigator, University of Minnesota (Data Coordinating Center)Steven M Scharf, MD, PhD, Principal investigator, University of Maryland, BaltimoreMark Dransfield, MD, Principal investigator, University of Alabama at BirminghamGeorge Washko, MD, Principal investigator, Brigham and Women's Hospital BostonRichard K Albert, MD, Principal investigator, Denver Health Medical CenterRichard Casaburi, MD, PhD, Principal investigator, Harbor-UCLA Research & Education InstituteDennis E Niewoehner, MD, Principal investigator, Minnesota Veterans Affairs Medical CenterGerard J Criner, MD, Principal investigator, Temple University Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061671
- Sponsor's protocol ID
- 689
- Other IDs
- U10HL074424
- Acronym
- STATCOPE
- Status last verified
- Dec 2017
- First submitted
- 2 Feb 2010
- Last updated
- 2 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Camac ER, Voelker H, Criner GJ; COPD Clinical Research Network and the Canadian Institutes of Health Research. Impact of COPD exacerbations leading to hospitalization on general and disease-specific quality of life. Respir Med. 2021 Sep;186:106526. doi: 10.1016/j.rmed.2021.106526. Epub 2021 Jun 29.
PubMed 34229290Rao AK, Del Carpio-Cano F, Janapati S, Zhao H, Voelker H, Lu X, Criner G; NIH COPD Clinical Research Network, the Canadian Institute of Health Research Investigators. Effects of simvastatin on tissue factor pathway of blood coagulation in STATCOPE (Simvastatin in the prevention of COPD exacerbations) trial. J Thromb Haemost. 2021 Jul;19(7):1709-1717. doi: 10.1111/jth.15282. Epub 2021 Apr 12.
PubMed 33638931Leitao Filho FS, Ra SW, Mattman A, Schellenberg RS, Criner GJ, Woodruff PG, Lazarus SC, Albert R, Connett JE, Han MK, Martinez FJ, Leung JM, Paul Man SF, Aaron SD, Reed RM, Sin DD; Canadian Respiratory Research Network (CRRN). Serum IgG subclass levels and risk of exacerbations and hospitalizations in patients with COPD. Respir Res. 2018 Feb 14;19(1):30. doi: 10.1186/s12931-018-0733-z.
PubMed 29444682Brown KE, Sin DD, Voelker H, Connett JE, Niewoehner DE, Kunisaki KM; COPD Clinical Research Network. Serum bilirubin and the risk of chronic obstructive pulmonary disease exacerbations. Respir Res. 2017 Oct 24;18(1):179. doi: 10.1186/s12931-017-0664-0.
PubMed 29065885Criner GJ, Connett JE, Aaron SD, Albert RK, Bailey WC, Casaburi R, Cooper JA Jr, Curtis JL, Dransfield MT, Han MK, Make B, Marchetti N, Martinez FJ, Niewoehner DE, Scanlon PD, Sciurba FC, Scharf SM, Sin DD, Voelker H, Washko GR, Woodruff PG, Lazarus SC; COPD Clinical Research Network; Canadian Institutes of Health Research. Simvastatin for the prevention of exacerbations in moderate-to-severe COPD. N Engl J Med. 2014 Jun 5;370(23):2201-10. doi: 10.1056/NEJMoa1403086. Epub 2014 May 18.
PubMed 24836125
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Placebo-Controlled Trial of SimvaSTATin in the Prevention of COPD Exacerbations (STATCOPE)
- ClinicalTrials.gov ID
- NCT01061671
- Acronym / sponsor ID
- STATCOPE / 689
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Exacerbation, Lung function, Cardiovascular, Smoking, Statins, Simvastatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Futility
- Enrolment
- 885 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Canadian Institutes of Health Research (CIHR), Ottawa Hospital Research Institute
- Study start
- Mar 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 3 Feb 2010 (estimated)
- Results
- Posted 26 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effect of daily administration of 40 mgms simvastatin taken for at least 12 months (range 12-36 months) on the frequency of exacerbations of chronic obstructive lung disease (COPD) in patients with moderate to severe COPD who are prone to exacerbations and do not have other indications for statin treatment.
Detailed description
COPD exacerbation is a common complication that significantly contributes to the high morbidity, mortality and costs associated with COPD. COPD exacerbations are associated with heightened lung inflammation that may have systemic implications (e.g., peripheral muscle weakness, cognitive impairment, depression, stroke, acute coronary syndrome, and atherosclerosis). Statins are potent agents that significantly reduce vascular events in patients with increased risks due to prior cardiac or cerebral vascular events and elevated lipid profiles. Statins have pleiotropic effects that extend well beyond their lipid lowering effects and may be potent anti-inflammatory agents. Retrospective data conducted in COPD patients indicate that statin use is associated with markedly decreased rates of COPD hospitalization and stabilization of lung function. Decreases in mortality in COPD due to complications of flu-like illnesses and deaths due to cardiovascular events have also been reported. Inflammatory biomarkers (C-reactive protein and interleukin- 6) are reported to be elevated in moderate to severe COPD patients who are prone to exacerbations. Inflammatory biomarkers (C-reactive protein and interleukin- 6) are reported to be reduced by statin therapy in patients with hyperlipidemia and cardiovascular diseases. Treatments that can effectively lessen the prevalence and severity of COPD exacerbations are desperately needed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| simvastatin | Active comparator | Drug: simvastatin40 mgms of simvastatin daily |
| placebo | Placebo comparator | Drug: PlaceboMatched placebo pill daily |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male and female subjects, 40-80 years of age.
- Clinical diagnosis of at least moderate COPD as defined by the GOLD criteria:
- Cigarette consumption of 10 pack-years or more. Patients may or may not be active smokers.
- Must meet one or more of the following 4 conditions
- Willingness to make return visits and availability by telephone for duration of study.
Key exclusion criteria (20 listed)
- Patients who:
- Documented history of active coronary heart disease, such as unstable angina, prior myocardial infarction, stroke, symptomatic peripheral vascular or carotid artery disease, or congestive heart failure within the past 3 months.
- A diagnosis of asthma.
- The presence of a diagnosis other than COPD that results in the patient being either medically unstable, or having a predicted life expectancy < 3 years.
- Special patient groups: prisoners, pregnant women, institutionalized patients
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 |
|---|---|---|
| simvastatinAlso: Zocor40 mgms of simvastatin daily | Drug | simvastatin |
| PlaceboAlso: sugar pillMatched placebo pill daily | Drug | placebo |
Primary outcome
Rates of COPD Exacerbations
Time frame: up to 37 months
3 secondary outcomes
Time to First COPD Exacerbation
Time frame: up to 37 months
Change in FEV1 (% Pred) From Baseline to Last Measure
Time frame: Baseline, last measure at up to 37 months
Acute Exacerbation COPD Hospitalization Rates (Events/Patient Year)
Time frame: up to 37 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34229290Camac ER, Voelker H, Criner GJ; COPD Clinical Research Network and the Canadian Institutes of Health Research. Impact of COPD exacerbations leading to hospitalization on general and disease-specific quality of life. Respir Med. 2021 Sep;186:106526. doi: 10.1016/j.rmed.2021.106526. Epub 2021 Jun 29.
- Derived from this study: PubMed 33638931Rao AK, Del Carpio-Cano F, Janapati S, Zhao H, Voelker H, Lu X, Criner G; NIH COPD Clinical Research Network, the Canadian Institute of Health Research Investigators. Effects of simvastatin on tissue factor pathway of blood coagulation in STATCOPE (Simvastatin in the prevention of COPD exacerbations) trial. J Thromb Haemost. 2021 Jul;19(7):1709-1717. doi: 10.1111/jth.15282. Epub 2021 Apr 12.
- Derived from this study: PubMed 29444682Leitao Filho FS, Ra SW, Mattman A, Schellenberg RS, Criner GJ, Woodruff PG, Lazarus SC, Albert R, Connett JE, Han MK, Martinez FJ, Leung JM, Paul Man SF, Aaron SD, Reed RM, Sin DD; Canadian Respiratory Research Network (CRRN). Serum IgG subclass levels and risk of exacerbations and hospitalizations in patients with COPD. Respir Res. 2018 Feb 14;19(1):30. doi: 10.1186/s12931-018-0733-z.
- Derived from this study: PubMed 29065885Brown KE, Sin DD, Voelker H, Connett JE, Niewoehner DE, Kunisaki KM; COPD Clinical Research Network. Serum bilirubin and the risk of chronic obstructive pulmonary disease exacerbations. Respir Res. 2017 Oct 24;18(1):179. doi: 10.1186/s12931-017-0664-0.
- Derived from this study: PubMed 24836125Criner GJ, Connett JE, Aaron SD, Albert RK, Bailey WC, Casaburi R, Cooper JA Jr, Curtis JL, Dransfield MT, Han MK, Make B, Marchetti N, Martinez FJ, Niewoehner DE, Scanlon PD, Sciurba FC, Scharf SM, Sin DD, Voelker H, Washko GR, Woodruff PG, Lazarus SC; COPD Clinical Research Network; Canadian Institutes of Health Research. Simvastatin for the prevention of exacerbations in moderate-to-severe COPD. N Engl J Med. 2014 Jun 5;370(23):2201-10. doi: 10.1056/NEJMoa1403086. Epub 2014 May 18.
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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.
John E Connett, PhD principal investigator
University of Minnesota (Data Coordinating Center)
Steven M Scharf, MD, PhD principal investigator
University of Maryland, Baltimore
Mark Dransfield, MD principal investigator
University of Alabama at Birmingham
51 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing simvastatin in people with Pulmonary Disease, Chronic Obstructive, run by University of Minnesota at 51 sites in 2 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 13 inclusion and 20 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: stopped early, as of the sponsor's last update on 2 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 26 Mar 2015). 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?
Rates of COPD Exacerbations (time frame: up to 37 months). 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 NCT01061671, which also lists 5 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 2 Jan 2018; AzTrials last refreshed its copy on 29 Oct 2026.