Chronic Obstructive Pulmonary DiseaseNCT01337661
A Study of the Inflammatory Pathways Associated With Chronic Obstructive Pulmonary Disease Exacerbations
An observational study of Chronic Obstructive Pulmonary Disease, run by MedImmune LLC at 1 site in Ireland.
Trial summary
The purpose of this study is to observe how the inflammatory pathways differ in subjects with chronic obstructive pulmonary disease (COPD) during an acute exacerbation of COPD (AECOPD). Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- How many people
- 26 participants
- Where
- 1 siteIreland
- Study dates
- Apr 2011to Feb 2012
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects referred to the hospital clinic with AECOPD
Who may be able to join
- Physician-diagnosed acute exacerbations of chronic obstructive pulmonary disease
- Current or ex-smoker with a tobacco history of 15 or more pack years
- Females of childbearing potential must use birth control for the duration of the study.
Who cannot join
- Evidence or history of clinically significant disease
- Subjects with asthma
- Subjects taking anti-leukotriene medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Study of the Cellular Inflammatory Mechanisms Associated With Chronic Obstructive Pulmonary Disease Exacerbations
The purpose of this study is to observe how the inflammatory pathways differ in subjects with chronic obstructive pulmonary disease (COPD) during an acute exacerbation of COPD (AECOPD).
Read the detailed description
This is an observational study in adult male and female subjects with COPD to collect blood, endobronchial tissues and BAL to investigate the inflammatory genes/pathways associated with AECOPD at the time of exacerbation (ie, active disease) and at 6 weeks later (ie, stable disease).
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Acute Exacerbation of COPD, AECOPD
- 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 |
|---|---|---|
| COPD subjects | Adult male and female subjects with COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of how inflammatory pathways differ in COPD subjects
Identify how inflammatory pathways differ in subjects with COPD during an acute exacerbation relative to when the disease is stable.
Measured: 6 weeks
Secondary outcomes (1)
Biomarker Sample Repository
Establish a biomarker sample repository to support future target validation for the treatment of subjects with COPD.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2012
- Study completionFeb 2012
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rene van der Merwe, MBChB, MFPM, Study director, MedImmune LtdProf. Connor Burke, Principal investigator, BCF Diagnostics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337661
- Sponsor's protocol ID
- CD-RI-INDP-1048
- Status last verified
- Aug 2012
- First submitted
- 13 Apr 2011
- Last updated
- 28 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of the Cellular Inflammatory Mechanisms Associated With Chronic Obstructive Pulmonary Disease Exacerbations
- ClinicalTrials.gov ID
- NCT01337661
- Acronym / sponsor ID
- CD-RI-INDP-1048
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Acute Exacerbation of COPD, AECOPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 19 Apr 2011 (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 purpose of this study is to observe how the inflammatory pathways differ in subjects with chronic obstructive pulmonary disease (COPD) during an acute exacerbation of COPD (AECOPD).
Detailed description
This is an observational study in adult male and female subjects with COPD to collect blood, endobronchial tissues and BAL to investigate the inflammatory genes/pathways associated with AECOPD at the time of exacerbation (ie, active disease) and at 6 weeks later (ie, stable disease).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD subjects | – | –Adult male and female subjects with COPD |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects referred to the hospital clinic with AECOPD
Key inclusion criteria (3 listed)
- Physician-diagnosed acute exacerbations of chronic obstructive pulmonary disease
- Current or ex-smoker with a tobacco history of 15 or more pack years
- Females of childbearing potential must use birth control for the duration of the study.
Key exclusion criteria (3 listed)
- Evidence or history of clinically significant disease
- Subjects with asthma
- Subjects taking anti-leukotriene medications
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
Identification of how inflammatory pathways differ in COPD subjects
Time frame: 6 weeks
Identify how inflammatory pathways differ in subjects with COPD during an acute exacerbation relative to when the disease is stable.
1 secondary outcome
Biomarker Sample Repository
Time frame: 6 weeks
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 28 Aug 2012.
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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.
Rene van der Merwe, MBChB, MFPM study director
MedImmune Ltd
Prof. Connor Burke principal investigator
BCF Diagnostics
1 site in 1 country: 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 1 site in Ireland.
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 3 inclusion and 3 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 28 Aug 2012. 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 Ireland. 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 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?
Identification of how inflammatory pathways differ in COPD subjects (time frame: 6 weeks). 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 28 Aug 2012.