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

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.

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Key information

Conditions

Smoking Behavior

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hamad Medical Corporation

Doha, Qatar

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Gene expression changes in the small airway epithelium (SAE)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

Hamad Medical Corporation
Weill Cornell Medical College in Qatar

Registry information

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Dec 27, 2013
Registry last updated: Apr 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed