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

Withdrawn

• Conditions: Chronic Obstructive Pulmonary Disease; Tuberculosis

• Registration Number: NCT02021747
• Lead Sponsor: Weill Medical College of Cornell University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-27
• Study Start: 2014-01
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

Exclusion Criteria:

• Non-smokers
• Females who are pregnant or nursing
• History of allergies to xylocaine, lidocaine, versed, valium, atropine, isoproterenol, terbutaline, aminophylline, or any local anesthetic

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Alveolar Macrophage	1 week	Changes in alveolar macrophage

Trial Locations

Locations (1)

Hamad Medical Corporation; 🇶🇦 Doha, Qatar