Association Between CytochromeP4501A2 and CytochromeP4502E1 Gene Polymorphisms and Metabolism of Theophylline

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001935
• Other study ID #: 81302846
• Status: Completed
• Phase: N/A
• First received: November 12, 2013
• Last updated: August 19, 2014
• Start date: September 2013
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: Zhujiang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
China	Zhujiang Hospital,Southern Medical Universtiy	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Theophylline clearance	Theophylline and it's metabolite(1,3-dimethyluric) blood concentration	Blood samples will be taken after receiving oral thoephylline for 14 days	No