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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02021708
• Other study ID #: 13-00055 [JIRB]
• Secondary ID: NPRP 09-742-3-19
• Status: Completed
• Phase: N/A
• First received: November 22, 2013
• Last updated: April 27, 2016
• Start date: January 2013
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardQatar: Hamad Medical Corporation
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Smoking

Locations

Country	Name	City	State
Qatar	Hamad Medical Corporation	Doha

Sponsors (3)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Hamad Medical Corporation, Weill Cornell Medical College in Qatar

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression changes in the small airway epithelium (SAE)	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.	3 days	No