Clinical trial NCT02021708: Effect of Shisha Smoking on the Biology of the Airway Epithelium in Qatar
Official title: Effect of Shisha Smoking on the Biology of the Airway Epithelium in Qatar
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Weill Cornell Medical College in Qatar
name: Hamad Medical Corporation
First posted: 2013-12-27
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects will be recruited in the pulmonary and smoking cessation clinics of HMC.

Brief summary: The purpose of this study is to learn about the effects of smoking shisha on the lungs, when compared to the effects of smoking cigarettes or of not smoking. The investigators hope to learn more about how shisha smokers should be monitored and treated once diseased.

Detailed description: Traditional shisha smoking is practiced by \~10% of the Qatari adult population. Although based on tobacco leaves, shisha smoking exposes the airway epithelium to a chemical insult of intensity and duration different from that of cigarette smoking. This study, a collaboration between WCMC-Qatar and WCMC-New York and the Hamad Medical Corporation (HMC), is focused on defining the biology of the airway epithelium of shisha smokers compared to non-smokers. Using approved protocols, bronchoscopy will be used to sample the airway epithelium, the site of the earliest changes associated with smoking. The transcriptome of the recovered epithelium will be assessed in the genomic core WCMC-Qatar for gene expression using microarrays and complete RNA sequencing using massive parallel sequencing.Based on this information, the epithelial DNA will be assessed for relevant SNPs, copy number variations and methylation status. Parallel studies will be carried out in cigarette smokers, providing a comprehensive catalog of shisha smoking-induced changes compared to cigarette smokers and non-smokers in this population.

Eligibility criteria: Non-smoker

Inclusion Criteria:

* Population living in Qatar
* Must provide informed consent
* Individuals must also have smoked less than 100 cigarettes and/or less than 10 shisha pipes in their lifetime
* Has normal pulmonary function test
* Has normal chest xray
* No signs of acute lung infection

Exclusion Criteria:

* Medical history of significant illness or other significant medical issues
* Regular shisha smoker
* Regular cigarette smoker
* Simultaneous cigarette plus shisha smoking

Shisha smoker

Inclusion Criteria:

* Population living in Qatar
* Must provide informed consent
* Must have smoked 5 pipe-yr
* Must currently smoke 5 pipes/wk
* Has normal function tests
* Has normal chest xray
* No signs of acute lung infection

Exclusion Criteria:

* Medical history of significant illness or other significant medical issues
* Regular cigarette smoker
* Simultaneous cigarette plus shisha smoking

Cigarette smoker

Inclusion Criteria:

* Population living in Qatar
* Must provide informed consent
* Confirmation of smoking status by urine testing
* Confirmation of smoking status by assessment of carboxyhemoglobin
* Has normal function tests
* Has normal chest xray
* No signs of acute lung infection

Exclusion Criteria:

* Medical history of significant illness or other significant medical issues
* Regular shisha smoker
* Simultaneous cigarette plus shisha smoking

Primary outcomes:
measure: Gene expression changes in the small airway epithelium (SAE)
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Corporation
Study officials:
affiliation: Weill Medical College of Cornell University
name: Matthew Walters, PhD
role: PRINCIPAL_INVESTIGATOR
References: