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NCT03015090 Clinical Trial

Association Study Between CYP1A2 Gene Polymorphisms and Metabolism of Theophylline

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:
Association Study Between CYP1A2 Gene Polymorphisms and Metabolism of Theophylline in Han and Uygur Patients With COPD

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03015090
Other study ID # 2016D01C013
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2017
Est. completion date June 1, 2017

Study information
Verified date March 2022
Source Kashgar 1st People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to determine whether common CYP1A2 gene polymorphisms effect metabolism of theophylline in Han and Uygur Patients with chronic obstructive pulmonary disease patients.

Recruitment information / eligibility
Status Completed
Enrollment 110
Est. completion date June 1, 2017
Est. primary completion date June 1, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Aged 18-75 years,Weight 40-80kg COPD patients, male or female; regularly visiting our hospital; taking a sustained-release preparation of theophylline continuously for at least 2 weeks Exclusion Criteria: - Patients with renal or hepatic dysfunction; Patients with congestive heart failure; Patients with hypothyroidism or hyperthyroidism; Patients currently taking drugs likely to effect theophylline metabolism or who had taken such drugs in the preceding week; Patients with extreme obesity Patients with very severe Chronic Obstructive Pulmonary Disease(COPD)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Theophylline
After oral theophylline 200mg per day for one week, blood sample will be collected for determining plasma concentrations of theophylline and it's metabolites and the genotypes of CYP1A2

Locations
Country Name City State
China Kashgar 1st People's Hospital Kashgar Xinjiang

Sponsors (2)
Lead Sponsor Collaborator
XiaoGuang Zou Southern Medical University, China

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma concentrations of theophylline Blood samples will be taken after receiving oral theophylline one week
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