NCT02021747|WithdrawnDMC
Study Stopped
Research Changed Directions
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Sponsor study identifier
Secondary identifiers
OTHER · Qatar National Research Fund
OTHER · HMC IRB
observational
0
1 country
1
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 22, 2013
Actual (reported)December 27, 2013
Actual (reported)January 2014
Date type not reportedThis date has not been verified as actual or estimated.
October 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Alveolar Macrophage
Changes in alveolar macrophage
1 week
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
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
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
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
Recruitment will be from the referral base of the responsible investigator and other physicians, and review of admissions and hospital database. Patients, who may qualify for this study, will be identified by chart review, physician referral, and recruited by study investigators. The source of potential subjects will be the population of potential subjects with TB (smokers or non smokers), and with both TB and COPD, as defined before. Accrual will be random with no bias as to gender or racial/ethnic group.
Hamad Medical Corporation
Doha, Qatar
Blood Biological material from the lungs
Ronald Crystal, MD
Weill Medical College of Cornell University
0 participants (actual enrollment reported by the registry).
First Submitted
November 22, 2013
First Posted
December 27, 2013
Study Start
January 2014
Date type not reportedThis date has not been verified as actual or estimated.
Effect of Inhaled Steroids on Gene Expression in the Lungs - 2
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Primary Completion
October 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 24, 2017
Record last verified: 2017-05
All results of the proposed studies will be published in international peer-reviewed scientific journals, presented at meetings in Qatar, the regional and international conferences, and disseminated through the local Qatari media, seminars and lectures for high school and college students. The original data will be available to interested investigators using the conventional standards of biomedical science.
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Source: ClinicalTrials.gov.
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