Association Between CytochromeP4501A2 and CytochromeP4502E1 Gene Polymorphisms and Metabolism of Theophylline

Sponsor

Zhujiang Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02001935

Collaborator

(none)

102

Enrollment

Location

Arm

Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to determine whether common CYP1A2 and CYP2E1 gene polymorphisms effect metabolism of theophylline in 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 :

102 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

Association Between CytochromeP4501A2(CYP1A2) and CytochromeP4502E1(CYP2E1) Gene Polymorphisms and Metabolism of Theophylline in a Chinese Population

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Other: theophylline	Drug: theophylline After oral theophylline 200mg per day for two weeks,bood sample will be collected for determining plasma concentrations of theophylline and it's metabolites and the genotypes of CYP1A2 and CYP2E1

Arm

Intervention/Treatment

Other: theophylline

Drug: theophylline

After oral theophylline 200mg per day for two weeks,bood sample will be collected for determining plasma concentrations of theophylline and it's metabolites and the genotypes of CYP1A2 and CYP2E1

Outcome Measures

Primary Outcome Measures

Theophylline clearance [Blood samples will be taken after receiving oral thoephylline for 14 days]
Theophylline and it's metabolite(1,3-dimethyluric) blood concentration

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,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 affect 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)