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

• ClinicalTrials.gov Identifier: NCT02021708
• Recruitment Status: Completed
• First Posted: December 27, 2013
• Last Update Posted: April 29, 2016
• Sponsor: Weill Medical College of Cornell University
• Collaborators: Weill Cornell Medical College in Qatar; Hamad Medical Corporation
• Information provided by (Responsible Party): Weill Medical College of Cornell University

Study Description

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.

Condition or disease
Smoking

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 64 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Effect of Shisha Smoking on the Biology of the Airway Epithelium in Qatar
• Study Start Date: January 2013
• Actual Primary Completion Date: January 2016
• Actual Study Completion Date: January 2016

Groups and Cohorts

Group/Cohort
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.
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.
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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Biospecimen Retention:   Samples With DNA

Blood

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

Subjects will be recruited in the pulmonary and smoking cessation clinics of HMC.

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

Contacts and Locations

Locations

Qatar

Hamad Medical Corporation

Doha, Qatar

Sponsors and Collaborators

Weill Medical College of Cornell University

Weill Cornell Medical College in Qatar

Hamad Medical Corporation

Investigators

• Principal Investigator: Matthew Walters, PhD; Weill Medical College of Cornell University

More Information

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT02021708
• Other Study ID Numbers: 13-00055 [JIRB]; NPRP 09-742-3-194 ( Other Identifier: Qatar National Research Fund )
• First Posted: December 27, 2013
• Last Update Posted: April 29, 2016
• Last Verified: April 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided