CClinicalTrials.gg
CompletedNCT02001935Updated Aug 20, 2014

Association Between CytochromeP4501A2 and CytochromeP4502E1 Gene Polymorphisms and Metabolism of Theophylline

An interventional study of theophylline in Chronic Obstructive Pulmonary Disease, sponsored by Zhujiang Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-08-20.

Sponsored by Zhujiang Hospital · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • COPD
  • theophylline
  • CYP1A2
  • CYP2E1
03

In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's enrollment of 102 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Zhujiang Hospital is the lead sponsor of 199 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Other
    theophylline

    Drug: theophylline

Interventions

  • Drugtheophylline

    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

06

What researchers measure

Primary outcomes

  1. Theophylline clearance

    Theophylline and it's metabolite(1,3-dimethyluric) blood concentration

    Time frame: Blood samples will be taken after receiving oral thoephylline for 14 days

07

Study locations

1 site
  • Zhujiang Hospital,Southern Medical Universtiy
    Guangzhou, Guangdong 510282, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02001935
Lead sponsor
Zhujiang Hospital
Responsible party
Sponsor
First posted
Dec 5, 2013
Start date
Sep 2013
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Aug 20, 2014

Study contacts

Wang Liqing, Doctor
principal investigator · Zhujiang Hospital,Southern Medical Unversity

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion