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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Tuberculosis Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Individuals with TB

Diagnosis of pulmonary tuberculosis without extra-pulmonary TB, confirmed by at least one of the following:

1. Symptoms consistent with TB
2. Chest X-rays and or chest CT consistent with TB
3. Positive PPD test
4. Positive sputum test

No interventions assigned to this group

Smokers

Active smoker as evidenced by self report and urine nicotine \>30 ng/mL and urine cotinine \>50 ng/mL

Diagnosis of pulmonary tuberculosis without extra-pulmonary TB, confirmed by at least one of the following:

1. Symptoms consistent with TB
2. Chest X-rays and or chest CT consistent with TB
3. Positive PPD test
4. Positive sputum test

No interventions assigned to this group

Non-smokers

Never smokers is defined as someone who has smoked \< 100 cigarettes per lifetime and whose urine nicotine \<2 ng/mL and urine cotinine \<5 ng/mL, at entry into the study

Diagnosis of pulmonary tuberculosis without extra-pulmonary TB, confirmed by at least one of the following:

1. Symptoms consistent with TB
2. Chest X-rays and or chest CT consistent with TB
3. Positive PPD test
4. Positive sputum test

No interventions assigned to this group

Individuals with COPD

All study subjects should meet the "Lung Disease" protocol criteria for having COPD may be of any stage (GOLD I - IV), be ambulatory and have no evidence of respiratory failure

Diagnosis of pulmonary tuberculosis without extra-pulmonary TB, confirmed by at least one of the following:

1. Symptoms consistent with TB
2. Chest X-rays and or chest CT consistent with TB
3. Positive PPD test
4. Positive sputum test

No interventions assigned to this group

Eligibility Criteria

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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

* 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

* 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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes