Pulmonary Disease, Chronic ObstructiveNCT02637219
Innate Immune Response in COPD
An observational study of Pulmonary Disease, Chronic Obstructive and Immunity, Innate, run by VA Puget Sound Health Care System at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the response of the immune system to bacterial components differs between patients with severe COPD compared to those with less severe COPD. Read more about this study
- Who is it for?
- Ages 50 to 89 years, men only
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Immunity, Innate, Inflammation
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jan 2008
- 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 50 to 89 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a clinical history of COPD recruited from a pulmonary subspecialty clinic at an academic medical center
Who may be able to join
- post-bronchodilator FEV1/FVC <0.7
- FEV1 < 80%
- > 10 pack-years tobacco smoking
- no respiratory illnesses or prednisone or antibiotics in the last 4 weeks
Who cannot join
- Primary diagnosis of asthma
- > 15% change in FEV1
- Chronic inflammatory or infectious disease
- Cancer
- Autoimmune disease
- Chronic renal failure with a creatinine > 1.5
Show all 9Show fewer
- Chronic liver disease
- Chronic antibiotic use
- Note: Due to difficulty recruiting patients after 6 participants were enrolled, the exclusion criteria were modified to allow patients with > 15% change in FEV1. The exclusion criteria were also changed to allow chronic renal failure not requiring dialysis, and non-metastatic cancer provided there was no diagnosis of lung cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System
Seattle, Washington, 98108
About this study
The purpose of this study is to determine whether the response of the immune system to bacterial components differs between patients with severe COPD compared to those with less severe COPD.
Read the detailed description
The airways of COPD patients are often colonized with bacteria leading to increased airway inflammation. This study sought to determine whether systemic cytokine responses to microbial pathogen-associated molecular patterns (PAMPs) are increased among subjects with severe COPD.
In an observational cross-sectional study of COPD subjects, PAMP-induced cytokine responses were measured in whole blood ex vivo. We used PAMPs derived from microbial products recognized by TLR 1, 2, 4, 5, 6, 7, and 8. Patterns of cytokine response to PAMPs were assessed using hierarchical clustering. One-sided t-tests were used to compare PAMP-induced cytokine levels in blood from patients with and without severe COPD, and for subjects with and without chronic bronchitis.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Immunity, Innate, Inflammation, Bronchitis, Chronic, Toll-Like Receptors
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Inflammation, Bronchitis, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine production (TNF-alpha, IL-6, IL-8, IL-10, IL-1RA, G-CSF, IL-1B, MCP-1).
A whole blood stimulation assay was performed on blood samples from study participants. The whole blood was stimulated using several pathogen-associated molecular patterns that were agonists to seven different TLR receptors: 1) Pam3SCK4, 2) Zymosan, 3) FSL-1, 4) LPS, 5) flagellin, 6) R848. After stimulation with the PAMP, the cytokine levels (TNF-alpha, IL-6, IL-8, IL-10, IL-1RA, G-CSF, IL-1B, and MCP-1) were measured and the cytokine level results are in picograms per liter. Note, there is no treatment in this observational non-interventional trial. Therefore the multiple cytokine levels for each patient will not be aggregated or summarized into one measure. This study was a small pilot study and the results are exploratory.
Measured: This is a cross-sectional study with no follow-up period. Therefore the study outcomes were measured at the baseline visit (Time = day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startMar 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Puget Sound Health Care System
- Sponsor type
- US federal agency
- Collaborators
- University of Washington, Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Vincent S. Fan, VA Puget Sound Health Care System
- Investigators
- Vincent Fan, MD MPH, Principal investigator, VA Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02637219
- Sponsor's protocol ID
- 01439
- Status last verified
- Dec 2015
- First submitted
- 3 Dec 2015
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innate Immune Response in COPD
- ClinicalTrials.gov ID
- NCT02637219
- Acronym / sponsor ID
- 01439
- Conditions
- Pulmonary Disease, Chronic Obstructive, Immunity, Innate, Inflammation, Bronchitis, Chronic, Toll-Like Receptors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- VA Puget Sound Health Care SystemUS federal agency
- Collaborators
- University of Washington, Novartis Pharmaceuticals
- Study start
- Mar 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 22 Dec 2015 (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 determine whether the response of the immune system to bacterial components differs between patients with severe COPD compared to those with less severe COPD.
Detailed description
The airways of COPD patients are often colonized with bacteria leading to increased airway inflammation. This study sought to determine whether systemic cytokine responses to microbial pathogen-associated molecular patterns (PAMPs) are increased among subjects with severe COPD.
In an observational cross-sectional study of COPD subjects, PAMP-induced cytokine responses were measured in whole blood ex vivo. We used PAMPs derived from microbial products recognized by TLR 1, 2, 4, 5, 6, 7, and 8. Patterns of cytokine response to PAMPs were assessed using hierarchical clustering. One-sided t-tests were used to compare PAMP-induced cytokine levels in blood from patients with and without severe COPD, and for subjects with and without chronic bronchitis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 50 to 89 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a clinical history of COPD recruited from a pulmonary subspecialty clinic at an academic medical center
Key inclusion criteria (4 listed)
- post-bronchodilator FEV1/FVC <0.7
- FEV1 < 80%
- > 10 pack-years tobacco smoking
- no respiratory illnesses or prednisone or antibiotics in the last 4 weeks
Key exclusion criteria (9 listed)
- Primary diagnosis of asthma
- > 15% change in FEV1
- Chronic inflammatory or infectious disease
- Cancer
- Autoimmune disease
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
Cytokine production (TNF-alpha, IL-6, IL-8, IL-10, IL-1RA, G-CSF, IL-1B, MCP-1).
Time frame: This is a cross-sectional study with no follow-up period. Therefore the study outcomes were measured at the baseline visit (Time = day 0)
A whole blood stimulation assay was performed on blood samples from study participants. The whole blood was stimulated using several pathogen-associated molecular patterns that were agonists to seven different TLR receptors: 1) Pam3SCK4, 2) Zymosan, 3) FSL-1, 4) LPS, 5) flagellin, 6) R848. After stimulation with the PAMP, the cytokine levels (TNF-alpha, IL-6, IL-8, IL-10, IL-1RA, G-CSF, IL-1B, and MCP-1) were measured and the cytokine level results are in picograms per liter. Note, there is no treatment in this observational non-interventional trial. Therefore the multiple cytokine levels for each patient will not be aggregated or summarized into one measure. This study was a small pilot study and the results are exploratory.
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 22 Dec 2015.
Related trials for Pulmonary Disease, Chronic Obstructive
RecruitingPhase 1
Ex Vivo-Expanded Regulatory T Cells Plus Low-Dose Interleukin-2 for Steroid-Refractory Chronic GVHD
Graft Versus Host Disease (cGvHD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)
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
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
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.
Vincent Fan, MD MPH principal investigator
VA Puget Sound Health Care System
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 Pulmonary Disease, Chronic Obstructive and Immunity, Innate, run by VA Puget Sound Health Care System at 1 site in United States.
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 4 inclusion and 9 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 22 Dec 2015. 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 United States. 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?
Cytokine production (TNF-alpha, IL-6, IL-8, IL-10, IL-1RA, G-CSF, IL-1B, MCP-1). (time frame: This is a cross-sectional study with no follow-up period. Therefore the study outcomes were measured at the baseline visit (Time = day 0)). 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 22 Dec 2015.