NCT00871637

Brief Summary

Airway macrophage impairment is a central feature in the immunopathogenesis of chronic obstructive pulmonary disease, regardless of smoking status.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

March 26, 2009

Last Update Submit

September 1, 2023

Conditions

Pulmonary Disease, Chronic ObstructiveBronchitis, ChronicOccupational DiseasesTobacco Use Disorder

Keywords

Pulmonary disease, chronic obstructiveAirway macrophagesSputum milieuAirway inflammationOccupational diseases

Outcome Measures

Primary Outcomes (1)

  • Comparison of airway macrophages for immune cell surface marker expression and phagocytic ability in adults with airflow obstruction & healthy controls

    Determine if airway macrophages from adult participants with airflow obstruction demonstrate impaired innate immune cell surface marker expression and phagocytic ability compared to healthy controls.

    One year

Secondary Outcomes (3)

  • Comparison of airway macrophages for cytokine responsiveness in adults with airflow obstruction & healthy controls

    One year

  • Comparison of airway macrophage cytokine responsiveness to whole blood cytokine responsiveness

    One year

  • Determining if immunomodulators in airway sputum milieu f predict airway macrophage phenotype and function

    One year

Study Arms (3)

Group One

Healthy non-smoking controls

Group Two

Smoking adults with chronic bronchitis/chronic obstructive pulmonary disease

Group Three

Non-smoking adults with chronic bronchitis/chronic obstructive pulmonary disease

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Three groups Group One : Healthy non-smoking controls Group Two : Smoking adults with chronic bronchitis/COPD Group Three: Non-smoking adults with chronic bronchitis/COPD

You may qualify if:

  • Medically stable to participate in induced sputums
  • Group One: Smoked less than 100 cigarettes in their lifetime Quit smoking greater than 10 years ago Pre-bronchodilator FEV1/FVC \> 70% Pre-bronchodilator FEV1 % predicted \> 80%
  • Group Two: Greater than a 20-pack year tobacco history Smoked in the last two years Post-bronchodilator FEV1/FVC \< 70%
  • Group Three:Have less than a 20-pack year tobacco history Quit smoking greater than 20 years ago Post-bronchodilator FEV1/FVC \< 70%

You may not qualify if:

  • Personal history of lung cancer
  • Pregnancy
  • Personal history of autoimmune disease
  • Currently taking oral/parental corticosteroids
  • Personal history of upper or lower respiratory tract infection in the prior four weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nebraska

Omaha, Nebraska, 68198, United States

Location

Related Publications (1)

  • Harting JR, Gleason A, Romberger DJ, Von Essen SG, Qiu F, Alexis N, Poole JA. Chronic obstructive pulmonary disease patients have greater systemic responsiveness to ex vivo stimulation with swine dust extract and its components versus healthy volunteers. J Toxicol Environ Health A. 2012;75(24):1456-70. doi: 10.1080/15287394.2012.722186.

    PMID: 23116451RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveBronchitis, ChronicOccupational DiseasesTobacco Use Disorder

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Jill A Poole, MD

    University of Nebraska

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2009

First Posted

March 30, 2009

Study Start

August 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

September 7, 2023

Record last verified: 2023-09

Locations

US(1)