Chronic Obstructive Pulmonary DiseaseNCT01268072
A Study to Evaluate Biomarkers in Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease, run by MedImmune LLC at 10 sites in 2 countries.
Trial summary
The primary objective of this study is to identify biomarkers that can be used for evaluation of efficacy in subjects presenting with AECOPD Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 61 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Feb 2011to Jan 2013
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects in this study will be adult males or females, ≥40 years of age, at increased risk for AECOPD (Cohort 1) or who present with severe AECOPD requiring hospitalization (Cohort 2).
Who may be able to join
- Age ≥ 40 years at the time of screening
- Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- Cohort 1 only: A primary diagnosis of clinically stable physician-diagnosed COPD upon entry into the study meeting one of the following criteria:
- Subjects who have experienced a severe AECOPD requiring inpatient hospitalization in the previous 12 months
- Subject who had one severe AECOPD requiring ED visits in the past 9 months
- Subjects who are currently on LTOT.
Show all 13Show fewer
- Cohort 1 only: Stable COPD for 4 weeks prior to screening, as defined by no change in ICS therapy and no use of oral corticosteroids or antibiotics for a respiratory tract infection.
- Cohort 1 only: Forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) < 0.70 or lower limits of normal (LLN).
- Cohort 1 only: FEV1 < 60% predicted normal value.
- Cohort 2 only: A primary diagnosis of physician-diagnosed AECOPD requiring admission to the hospital.
- Current smoker or ex-smoker with a tobacco history of ≥ 10 pack-years (one pack year = 20 cigarettes smoked per day for 1 year).
- Ability and willingness to complete the appropriate follow-up period of time as required by the protocol.
- Able to read and write and use the electronic devices (English or Spanish version).
Who cannot join
- Participation (defined as administration of at least one dose of investigational product) in another clinical study, the last follow-up visit of which is within 12 weeks (for a small molecule drug) and (6 months for a large molecule drug) of entry into this study.
- Any condition that, in the opinion of the investigator would interfere with interpretation of subject safety or study results.
- Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
- The presence of another chronic pulmonary or systemic disease, which in the opinion of the investigator or medical monitor might affect the analysis of the data (eg, idiopathic pulmonary fibrosis, sarcoidosis, active cancer or autoimmune disease).
- History of immunodeficiency.
- Current alcohol or drug abuse or a history of unsuccessfully treated alcohol or drug abuse within the past year.
- Cohort 2 only: Diagnosis of an acute disease/condition (eg, congestive heart failure, acute myocardial infarction, pneumonia, or pulmonary embolus) that is the primary reason for the subject's hospitalization.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
United States9 sites
Research Site
Baltimore, Maryland, 21201
Research Site
Buffalo, New York, 14215
Research Site
Cincinnati, Ohio, 45267
Research Site
Houston, Texas, 77030
Research Site
Philadelphia, Pennsylvania, 19140
Research Site
Pittsburgh, Pennsylvania, 15213
Research Site
Providence, Rhode Island, 02903
Research Site
Springfield, Massachusetts, 01199
Research Site
St Louis, Missouri, 63110
About this study
Official title: A Prospective Observational Study to Evaluate Biomarkers in Acute Exacerbations in Chronic Obstructive Pulmonary Disease
The primary objective of this study is to identify biomarkers that can be used for evaluation of efficacy in subjects presenting with AECOPD
Read the detailed description
Identify biomarkers that can be used for evaluation of efficacy in subjects presenting with AECOPD by evaluating longitudinal changes and the interrelationship of blood and sputum biomarkers with physiological endpoints and symptom measures in stable subjects with COPD likely to experience a future AECOPD, and in subjects during severe AECOPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 2 | Subjects who are recruited on admission to hospital for AECOPD. | |
| Cohort 1 | Subjects with COPD who are stable, but at risk of presenting with an AECOPD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify biomarkers for evaluation of efficacy in subjects presenting with AECOPD
Investigate changes in physiological measures, symptoms, and blood, urine and sputum biomarkers in subjects with stable COPD during AECOPD, and as subjects return to clinical stability.
Measured: 12 months
Secondary outcomes (1)
Hospitalization, treatment and discharge of COPD subjects
Gain an understanding of the reasons subjects with COPD may be hospitalized for their AECOPD and to understand the criteria physicians use for treatment and discharge.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2010 (estimated)
- Study startFeb 2011
- Primary completionNov 2012
- Study completionJan 2013
Why it stopped: Study was completed with 69 subjects enrolled due to difficult enrolment and adequate biomarker data was avaible with 69 subjects in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joseph Parker, MD, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268072
- Sponsor's protocol ID
- MI-CP221
- Status last verified
- Feb 2013
- First submitted
- 28 Dec 2010
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Evaluate Biomarkers in Acute Exacerbations in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT01268072
- Acronym / sponsor ID
- MI-CP221
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was completed with 69 subjects enrolled due to difficult enrolment and adequate biomarker data was avaible with 69 subjects in the study.
- Enrolment
- 61 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 29 Dec 2010 (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 primary objective of this study is to identify biomarkers that can be used for evaluation of efficacy in subjects presenting with AECOPD
Detailed description
Identify biomarkers that can be used for evaluation of efficacy in subjects presenting with AECOPD by evaluating longitudinal changes and the interrelationship of blood and sputum biomarkers with physiological endpoints and symptom measures in stable subjects with COPD likely to experience a future AECOPD, and in subjects during severe AECOPD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 2 | – | –Subjects who are recruited on admission to hospital for AECOPD. |
| Cohort 1 | – | –Subjects with COPD who are stable, but at risk of presenting with an AECOPD. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects in this study will be adult males or females, ≥40 years of age, at increased risk for AECOPD (Cohort 1) or who present with severe AECOPD requiring hospitalization (Cohort 2).
Key inclusion criteria (13 listed)
- Age ≥ 40 years at the time of screening
- Written informed consent and any locally required authorization (eg, HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.
- Cohort 1 only: A primary diagnosis of clinically stable physician-diagnosed COPD upon entry into the study meeting one of the following criteria:
- Subjects who have experienced a severe AECOPD requiring inpatient hospitalization in the previous 12 months
- Subject who had one severe AECOPD requiring ED visits in the past 9 months
Key exclusion criteria (7 listed)
- Participation (defined as administration of at least one dose of investigational product) in another clinical study, the last follow-up visit of which is within 12 weeks (for a small molecule drug) and (6 months for a large molecule drug) of entry into this study.
- Any condition that, in the opinion of the investigator would interfere with interpretation of subject safety or study results.
- Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
- The presence of another chronic pulmonary or systemic disease, which in the opinion of the investigator or medical monitor might affect the analysis of the data (eg, idiopathic pulmonary fibrosis, sarcoidosis, active cancer or autoimmune disease).
- History of immunodeficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify biomarkers for evaluation of efficacy in subjects presenting with AECOPD
Time frame: 12 months
Investigate changes in physiological measures, symptoms, and blood, urine and sputum biomarkers in subjects with stable COPD during AECOPD, and as subjects return to clinical stability.
1 secondary outcome
Hospitalization, treatment and discharge of COPD subjects
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Study was completed with 69 subjects enrolled due to difficult enrolment and adequate biomarker data was avaible with 69 subjects in the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
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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.
Joseph Parker, MD study director
MedImmune LLC
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by MedImmune LLC at 10 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 7 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 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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. 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?
The study was stopped early (reason given: Study was completed with 69 subjects enrolled due to difficult enrolment and adequate biomarker data was avaible with 69 subjects in the 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?
Identify biomarkers for evaluation of efficacy in subjects presenting with AECOPD (time frame: 12 months). 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 20 Feb 2013.