Back to resultsAssociation Study Between CYP1A2 Gene Polymorphisms and Metabolism of Theophylline
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Theophylline
Sponsored by
About this trial
This is an interventional other trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, CYP1A2, Theophylline
Eligibility Criteria
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)
Sites / Locations
- Kashgar 1st People's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
theophylline
Arm Description
Outcomes
Primary Outcome Measures
Plasma concentrations of theophylline
Blood samples will be taken after receiving oral theophylline
Secondary Outcome Measures
Full Information
NCT ID
NCT03015090
First Posted
January 3, 2017
Last Updated
March 2, 2022
Sponsor
XiaoGuang Zou
Collaborators
Southern Medical University, China
1. Study Identification
Unique Protocol Identification Number
NCT03015090
Brief Title
Association Study Between CYP1A2 Gene Polymorphisms and Metabolism of Theophylline
Official Title
Association Study Between CYP1A2 Gene Polymorphisms and Metabolism of Theophylline in Han and Uygur Patients With COPD
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
June 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
XiaoGuang Zou
Collaborators
Southern Medical University, China
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, CYP1A2, Theophylline
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
theophylline
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Theophylline
Intervention Description
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
Primary Outcome Measure Information:
Title
Plasma concentrations of theophylline
Description
Blood samples will be taken after receiving oral theophylline
Time Frame
one week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Kashgar 1st People's Hospital
City
Kashgar
State/Province
Xinjiang
ZIP/Postal Code
844000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Association Study Between CYP1A2 Gene Polymorphisms and Metabolism of Theophylline
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