Effect of Shisha Smoking on the Biology of the Airway Epithelium in Qatar

Completed

• Conditions: Smoking

• Registration Number: NCT02021708
• Lead Sponsor: Weill Medical College of Cornell University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2013-12-19
• Study First Posted: 2013-12-27
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-27
• Last Update Posted: 2016-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gene expression changes in the small airway epithelium (SAE)	3 days	We will measure the effect that shisha smoking has on the small airway epithelium (SAE) by measuring parameters such as the SAE gene expression in shisha smokers (i.e., non-cigarette smokers). We will compare these parameters to the same parameters measured in non-smokers and cigarette smokers.

Trial Locations

Locations (1)

Hamad Medical Corporation; 🇶🇦 Doha, Qatar