Drug Interaction Study of Azithromycin and Theophylline

N/ACompletedNCT02023554

Zhujiang Hospital40 enrolled

Overview

Macrolides are potent inhibitors of cytochrome P450 isoenzyme 3A4（CYP3A4）and thus interfere with the pharmacokinetics of many other drugs that are metabolised by this enzyme like theophylline.The aim of this study is to determine whether azithromycin can effect theophylline metabolism in patients.

In this non-blinded,auto-control study,patients with Chronic Obstructive Pulmonary Disease（COPD）or asthma will serve as their own controls during the 2-week treatment phase.The subjects will be co-administered oral doses of sustained release theophylline (100mg tablets,twice daily) and azithromycin (2x250mg capsules,once daily )in the first week.Then patients will received theophylline therapy alone with the same dose in the second week.Blood samples for the measurement of theophylline plasma concentrations will be collected on Days 8 and 15 prior to dosing.All adverse events whether elicited by query, spontaneously reported or observed by clinic staff will be evaluated by the investigator and reported in the subject's case report form.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease Asthma

Interventions

Theophylline with azithromycinDRUG

Drug: Theophylline(100mg,sustained release tablets). Multi-dose of theophylline(100mg,twice daily) will administered at 8 am and 8 pm from day 1 to day 7. Drug:Azithromycin(250mg, capsules). Multi-dose of azithromycin(500mg,once daily) will administered at 8 pm from day 1 to day 7.

Theophylline aloneDRUG

Drug: Theophylline(100mg,sustained release tablet). Multi-dose of theophylline(100mg,twice daily) will administered at 8 am and 8 pm from day 8 to day 14.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients with COPD or asthma，aged 18-75 years; * regularly visiting our hospital; * meeting the indications for azithromycin and theophylline simultaneously; Exclusion Criteria: * patients with renal or hepatic dysfunction; * patients with congestive heart failure; * patients with hypothyroidism or hyperthyroidism; * patients taking drugs likely to affect the theophylline metabolism in the preceding week; * patients with severe chronic obstructive pulmonary disease,asthma or respiratory infection;

Locations (1)

Zhujiang Hospital,Southern Medical Universtiy

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

steady-state plasma concentration of theophylline

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

Time frame: blood samples for theophylline will be collected on Days 8 and 15 before dosing

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.