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Association Study Between CYP1A2 Gene Polymorphisms and Metabolism of Theophylline

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03015090
Recruitment Status : Unknown
Verified January 2017 by XiaoGuang Zou, Kashgar 1st People's Hospital.
Recruitment status was:  Recruiting
First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Collaborator:
Southern Medical University, China
Information provided by (Responsible Party):
XiaoGuang Zou, Kashgar 1st People's Hospital

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Association Study Between CYP1A2 Gene Polymorphisms and Metabolism of Theophylline in Han and Uygur Patients With COPD
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Plasma concentrations of theophylline [ Time Frame: one week ]
    Blood samples will be taken after receiving oral theophylline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015090


Contacts
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Contact: Xiaoguang Zou +86-09982962533 zxgksrmyy@163.com
Contact: Hanzohra Upur +86-18699822959 hanzuola@163.com

Locations
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China, Xinjiang
Kashgar 1st People's Hospital Recruiting
Kashgar, Xinjiang, China, 844000
Contact: Hanzohra Upur, Master    +86-18699822959    hanzuola@163.com   
Sponsors and Collaborators
XiaoGuang Zou
Southern Medical University, China
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Responsible Party: XiaoGuang Zou, Professor of Pharmacy, Kashgar 1st People's Hospital
ClinicalTrials.gov Identifier: NCT03015090    
Other Study ID Numbers: 2016D01C013
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by XiaoGuang Zou, Kashgar 1st People's Hospital:
COPD
CYP1A2
Theophylline
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Theophylline
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents