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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02021747
• Other study ID #: 14-00055 [JIRB]
• Secondary ID: NPRP 5-400-3-107
• Status: Withdrawn
• Phase: N/A
• First received: November 22, 2013
• Last updated: May 23, 2017
• Start date: January 2014
• Est. completion date: October 2016

Study information

• Verified date: May 2017
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Disease Susceptibility
• Lung Diseases
• Lung Diseases, Obstructive
• Mycobacterium Infections
• Pulmonary Disease, Chronic Obstructive
• Tuberculosis

Locations

Country	Name	City	State
Qatar	Hamad Medical Corporation	Doha

Sponsors (3)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Hamad Medical Corporation, Weill Cornell Medical College in Qatar

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alveolar Macrophage	Changes in alveolar macrophage	1 week