TuberculosisNCT02021747
Biologic Basis Of Increased Susceptibility Of Smokers To Pulmonary Infection With Mycobacterium Tuberculosis
An observational study of Tuberculosis and Chronic Obstructive Pulmonary Disease, run by Weill Medical College of Cornell University at 1 site in Qatar.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Chronic Obstructive Pulmonary Disease
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteQatar
- Study dates
- Jan 2014to Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Medical subject headings
- Tuberculosis, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | |
| 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 | |
| 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 | |
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar Macrophage
Changes in alveolar macrophage
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Why it stopped: Research Changed Directions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Hamad Medical Corporation, Weill Cornell Medical College in Qatar
- Responsible party
- Sponsor
- Investigators
- Ronald Crystal, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021747
- Sponsor's protocol ID
- 14-00055 [JIRB]
- Other IDs
- NPRP 5-400-3-107, 11262/11
- Status last verified
- May 2017
- First submitted
- 22 Nov 2013
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biologic Basis Of Increased Susceptibility Of Smokers To Pulmonary Infection With Mycobacterium Tuberculosis
- ClinicalTrials.gov ID
- NCT02021747
- Acronym / sponsor ID
- 14-00055 [JIRB]
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Research Changed Directions
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Hamad Medical Corporation, Weill Cornell Medical College in Qatar
- Study start
- Jan 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 27 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Alveolar Macrophage
Time frame: 1 week
Changes in alveolar macrophage
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Crystal, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Chronic Obstructive Pulmonary Disease, run by Weill Medical College of Cornell University at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alveolar Macrophage (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017.