NCT02001935

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Sep 2013

Shorter than P25 for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2013

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 5, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

August 20, 2014

Status Verified

July 1, 2014

Enrollment Period

10 months

First QC Date

November 12, 2013

Last Update Submit

August 19, 2014

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDtheophyllineCYP1A2CYP2E1

Outcome Measures

Primary Outcomes (1)

  • Theophylline clearance

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

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

Study Arms (1)

theophylline

OTHER
Drug: theophylline

Interventions

theophyllineDRUG

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

theophylline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital,Southern Medical Universtiy

Guangzhou, Guangdong, 510282, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Theophylline

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Wang Liqing, Doctor

    Zhujiang Hospital,Southern Medical Unversity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2013

First Posted

December 5, 2013

Study Start

September 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

August 20, 2014

Record last verified: 2014-07

Locations

CN(1)