Biologic Basis Of Increased Susceptibility Of Smokers To Pulmonary Infection With Mycobacterium Tuberculosis

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02021747

Enrollment

Registered

2013-12-27

Start date

2014-01-31

Completion date

2016-10-31

Last updated

2017-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease, Tuberculosis

Brief summary

Identify a biologic (molecular) basis for the increased susceptibility of cigarette smokers to pulmonary TB (Mtb) by testing the hypothesis that smoking reprograms AM polarization towards a distinct phenotype associated with impaired host defense function against Mtb and that normalization of that phenotype via therapeutic modulation of the Alveolar Macrophage (AM) polarization or smoking cessation can restore the anti-Mtb host defense function of AM.

Detailed description

Samples from Non-Smokers with TB, Smokers with TB and Smokers with COPD and TB will be collected in Qatar under JIRB 14-00055. All subjects will be undergoing a clinical bronchoscopy as part of their disease evaluation and will be asked to give additional samples for research. All in vivo processing of specimens from subjects with TB will be performed in Qatar. Mycobacterium tuberculosis infection (Mtb) continues to have a detrimental impact of public health worldwide. Based on the epidemiological evidence linking smoking, COPD and Mtb, and our preliminary data we hypothesize that smoking reprograms Alveolar Macrophages (AM) polarization towards a distinct phenotype associated with impaired host defense function against Myobacterium tuberculosis (Mtb) and that normalization of that phenotype via therapeutic modulation of the Alveolar Macrophages (AM) polarization or smoking cessation can restore the anti-Mtb host defense function of AM.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

Smokers and Non-smokers with TB Inclusion Criteria: * Must provide informed consent * Current smokers and non-smokers * Undergoing clinical bronchoscopy as required by their doctor for evaluation of their disease * Diagnosis of pulmonary tuberculosis without extra-pulmonary TB, confirmed by at least one of the following: * Symptoms consistent with TB * Chest xray and or chest CT with TB * Positive PPD test * Positive sputum test

Exclusion criteria

* Females who are pregnant or nursing * History of allergies to xylocaine, lidocaine, versed, valium, atropine, isoproterenol, terbutaline, aminophylline, or any local anesthetic Smokers with TB and COPD Inclusion Criteria: * Must provide informed consent * Current smokers with COPD * Undergoing clinical bronchoscopy as required by their doctor for evaluation of their disease * Diagnosis of pulmonary tuberculosis without extra-pulmonary TB, confirmed bu at least one of the following: * Symptoms consistent with TB * Chest xray and or chest CT consistent with TB * Positive PPD test * Positive sputum test

Design outcomes

Primary

Measure	Time frame	Description
Alveolar Macrophage	1 week	Changes in alveolar macrophage

Countries

Qatar

Outcome results