Association Study Between CYP1A2 Gene Polymorphisms and Metabolism of Theophylline

Overview

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.

Full Title of Study: “Association Study Between CYP1A2 Gene Polymorphisms and Metabolism of Theophylline in Han and Uygur Patients With COPD”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 1, 2017

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: theophylline

Clinical Trial Outcome Measures

Primary Measures

  • Plasma concentrations of theophylline
    • Time Frame: one week
    • Blood samples will be taken after receiving oral theophylline

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • XiaoGuang Zou
  • Collaborator
    • Southern Medical University, China
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: XiaoGuang Zou, Professor of Pharmacy – Kashgar 1st People’s Hospital

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