Association Study Between CYP1A2 Gene Polymorphisms and Metabolism of Theophylline

Sponsor

XiaoGuang Zou (Other)

Overall Status

Completed

CT.gov ID

NCT03015090

Collaborator

Southern Medical University, China (Other)

110

Enrollment

Location

Arm

Actual Duration (Months)

22.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Theophylline	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: theophylline	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

Arm

Intervention/Treatment

Experimental: theophylline

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

Outcome Measures

Primary Outcome Measures

Plasma concentrations of theophylline [one week]
Blood samples will be taken after receiving oral theophylline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)