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

NCT ID: NCT02021708

Last Updated: 2016-04-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 64 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2016-01-31

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.

Conditions

Smoking

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Non-smoker

This group will include individuals without any history of lung disease, including asthma, and without recurrent or acute pulmonary disease. Individuals must also have smoked less than 100 cigarettes and/or less than 10 shisha pipes in their lifetime.

No interventions assigned to this group

Shisha smoker

This group will include individuals who have a shisha smoking history of more than 5 pipe-years and must currently smoke more than 5 pipes per week. Individuals must not show any signs of acute lung infection or have medical history of significant illness or other significant medical issues.

No interventions assigned to this group

Cigarette smoker

This group will include individuals who have a cigarette smoking history that will be confirmed by urine testing. Individuals must not show any signs of acute lung infection or have medical history of significant illness or other significant medical issues.

No interventions assigned to this group

Eligibility Criteria

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

• 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

• 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
• Regular cigarette smoker
• Simultaneous cigarette plus shisha smoking

Shisha smoker

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

Cigarette smoker

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Weill Cornell Medical College in Qatar

OTHER

Sponsor Role: collaborator

Hamad Medical Corporation

INDUSTRY

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthew Walters, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Hamad Medical Corporation

Doha, , Qatar

Countries

Qatar

Other Identifiers

NPRP 09-742-3-194

Identifier Type: OTHER

Identifier Source: secondary_id

13-00055 [JIRB]

Identifier Type: -

Identifier Source: org_study_id