NCT03015090

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

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

Timeline
Completed

Started Jan 2017

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

January 1, 2017

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

5 months

First QC Date

January 3, 2017

Last Update Submit

March 2, 2022

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPDCYP1A2Theophylline

Outcome Measures

Primary Outcomes (1)

  • Plasma concentrations of theophylline

    Blood samples will be taken after receiving oral theophylline

    one week

Study Arms (1)

theophylline

EXPERIMENTAL
Drug: Theophylline

Interventions

TheophyllineDRUG

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

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,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

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 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kashgar 1st People's Hospital

Kashgar, Xinjiang, 844000, 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 Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Pharmacy

Study Record Dates

First Submitted

January 3, 2017

First Posted

January 9, 2017

Study Start

January 1, 2017

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

March 17, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

Locations

CN(1)