COPDNCT02638194
Adverse Health Effects of Mainstream and Secondhand Hookah Smoke in NYC Hookah Bars
A study testing Active smoking of Tobacco Hookah for 2 hours, Exposure to tobacco hookah second hand smoke and Visit a win bar in people with COPD, run by NYU Langone Health at 1 site in United States.
Trial summary
The primary purpose of this study is to examine the health effects of mainstream and secondhand hookah (i.e. water pipe) smoke on pulmonary and cardiovascular functions as well as serum levels of inflammatory biomarkers. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- Active smoking of Tobacco Hookah for 2 hours, Exposure to tobacco hookah second hand smoke and Visit a win bar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Sep 2015
- Phase
- Interventional
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Competent adult English speaking subjects
- Have used hookah in the past
Who cannot join
- Age <21
- Pregnancy
- Current cigarette smokers
- Has pulmonary disease, such as asthma or Chronic Obstructive Pulmonary Disease (COPD)
- Subjects are unable to give voluntary informed consent because they are non English speaking, are unable to read or write, or any other impediments that prohibits giving written informed consent
- Recent nasal surgery (within 6 months)
- History of bleeding or other blood related disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
The primary purpose of this study is to examine the health effects of mainstream and secondhand hookah (i.e. water pipe) smoke on pulmonary and cardiovascular functions as well as serum levels of inflammatory biomarkers. Investigators would like to demonstrate that inhalation of both mainstream and secondhand smoke generated by hookah produces adverse pulmonary and cardiovascular effects and alterations in serum levels of inflammatory biomarkers.
Read the detailed description
A total of 20 participants are going to be enrolled in this study; 10 participants smoke hookah and 10 participants are exposed to second hand hookah smoke for 2 hours in NYC hookah bars. Subjects in the control group will also be paired as they were for the hookah bar visit but will visit a control location, where they will be asked to consume a similar amount of food and drink at a wine bar. Pulmonary function, cardiovascular changes, and blood and urine markers of inflammatory mediators before, immediately after and 24 hours after the participants' visits to hookah bars and wine bars will be examined. Air quality monitoring will also be performed at the hookah bar and at the control location. Physiological changes will be assessed by measuring pulmonary function, blood pressure, heart rate, and blood oxygenation status. To determine the extent of tobacco exposure and associated inflammatory changes from secondhand hookah smoke, investigators will measure blood inflammatory biomarkers, oxidative stress, gene expression, tobacco-related carcinogenic metabolites, and exhaled carbon dioxide levels.
- Conditions
- COPD
- Being tested
- Active smoking of Tobacco Hookah for 2 hours, Exposure to tobacco hookah second hand smoke, Visit a win bar
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), smoking, secondhand smoke
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active smoking of Tobacco Hookah for 2 hoursOther
Exposure to tobacco hookah second hand smokeOther
Visit a win barOther
Participants will visit a wine bar for food and/or drinks
| Study group | Role | What they receive |
|---|---|---|
| Hookah Smoking Group | Active comparator | 10 participants will smoke tobacco hookah for 2 hours Receives: Other: Active smoking of Tobacco Hookah for 2 hours; Other: Visit a win bar |
| Hookah Secondhand Smoke Group | Active comparator | 10 individuals will be exposed to secondhand hookah tobacco smoke for 2 hours Receives: Other: Exposure to tobacco hookah second hand smoke; Other: Visit a win bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in exhaled carbon dioxide measured by pulmonary function measure using a portable spirometer
Measured: subsequently after 2 hours of hookah smoking or smoke exposure and 24 hours after participants' visit hookah and wine bars.
Changes in Heart Rate measured by a portable monitor worn during encounters
Measured: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in blood oxygenation levels measured by a pulse oximeter
Measured: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of tobacco-related carcinogenic metabolite cotinine in saliva samples
Measured: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker endothelin
Measured: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker IL-10
Measured: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker IL-8
Measured: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker IL-6
Measured: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker CRP
Measured: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker IL-1a
Measured: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker IFN-g
Measured: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker TNF-a
Measured: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker GM-CSF
Measured: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker E-selectin
Measured: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker thrombomodulin
Measured: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker vWF
Measured: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Secondary outcomes (1)
Changes in Air Quality measured by an aethelometer
Measured: 2 hours spent at hookah bar
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2015 (estimated)
- Study startJul 2014
- Primary completionOct 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Weitzman, MD, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638194
- Sponsor's protocol ID
- 14-00370
- Status last verified
- Dec 2015
- First submitted
- 11 Dec 2015
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Health Effects of Mainstream and Secondhand Hookah Smoke in NYC Hookah Bars
- ClinicalTrials.gov ID
- NCT02638194
- Acronym / sponsor ID
- 14-00370
- Conditions
- COPD
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD), smoking, secondhand smoke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 23 Dec 2015 (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.
The primary purpose of this study is to examine the health effects of mainstream and secondhand hookah (i.e. water pipe) smoke on pulmonary and cardiovascular functions as well as serum levels of inflammatory biomarkers. Investigators would like to demonstrate that inhalation of both mainstream and secondhand smoke generated by hookah produces adverse pulmonary and cardiovascular effects and alterations in serum levels of inflammatory biomarkers.
Detailed description
A total of 20 participants are going to be enrolled in this study; 10 participants smoke hookah and 10 participants are exposed to second hand hookah smoke for 2 hours in NYC hookah bars. Subjects in the control group will also be paired as they were for the hookah bar visit but will visit a control location, where they will be asked to consume a similar amount of food and drink at a wine bar. Pulmonary function, cardiovascular changes, and blood and urine markers of inflammatory mediators before, immediately after and 24 hours after the participants' visits to hookah bars and wine bars will be examined. Air quality monitoring will also be performed at the hookah bar and at the control location. Physiological changes will be assessed by measuring pulmonary function, blood pressure, heart rate, and blood oxygenation status. To determine the extent of tobacco exposure and associated inflammatory changes from secondhand hookah smoke, investigators will measure blood inflammatory biomarkers, oxidative stress, gene expression, tobacco-related carcinogenic metabolites, and exhaled carbon dioxide levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hookah Smoking Group | Active comparator | Other: Active smoking of Tobacco Hookah for 2 hours, Other: Visit a win bar10 participants will smoke tobacco hookah for 2 hours |
| Hookah Secondhand Smoke Group | Active comparator | Other: Exposure to tobacco hookah second hand smoke, Other: Visit a win bar10 individuals will be exposed to secondhand hookah tobacco smoke for 2 hours |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Competent adult English speaking subjects
- Have used hookah in the past
Key exclusion criteria (7 listed)
- Age <21
- Pregnancy
- Current cigarette smokers
- Has pulmonary disease, such as asthma or Chronic Obstructive Pulmonary Disease (COPD)
- Subjects are unable to give voluntary informed consent because they are non English speaking, are unable to read or write, or any other impediments that prohibits giving written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active smoking of Tobacco Hookah for 2 hours | Other | Hookah Smoking Group |
| Exposure to tobacco hookah second hand smoke | Other | Hookah Secondhand Smoke Group |
| Visit a win barParticipants will visit a wine bar for food and/or drinks | Other | Hookah Secondhand Smoke Group, Hookah Smoking Group |
Primary outcome
Changes in exhaled carbon dioxide measured by pulmonary function measure using a portable spirometer
Time frame: subsequently after 2 hours of hookah smoking or smoke exposure and 24 hours after participants' visit hookah and wine bars.
Changes in Heart Rate measured by a portable monitor worn during encounters
Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in blood oxygenation levels measured by a pulse oximeter
Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of tobacco-related carcinogenic metabolite cotinine in saliva samples
Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker endothelin
Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker IL-10
Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker IL-8
Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker IL-6
Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker CRP
Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker IL-1a
Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker IFN-g
Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker TNF-a
Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker GM-CSF
Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker E-selectin
Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker thrombomodulin
Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
Changes in measure of blood inflammatory marker vWF
Time frame: subsequently after 2 hours of hookah smoking and 24 hours after participants' visit hookah and wine bars.
1 secondary outcome
Changes in Air Quality measured by an aethelometer
Time frame: 2 hours spent at hookah bar
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
- Individual participant dataSharing planned: No
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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.
Michael Weitzman, MD principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active smoking of Tobacco Hookah for 2 hours, Exposure to tobacco hookah second hand smoke and Visit a win bar in people with COPD, run by NYU Langone Health at 1 site in United States.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 23 Dec 2015. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in exhaled carbon dioxide measured by pulmonary function measure using a portable spirometer (time frame: subsequently after 2 hours of hookah smoking or smoke exposure and 24 hours after participants' visit hookah and wine bars.). The study lists 16 primary outcomes in all. 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 23 Dec 2015.