Drug Interaction Study of Azithromycin and Theophylline

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Asthma
• Interventions: Drug: Theophylline with azithromycin; Drug: Theophylline alone

• Registration Number: NCT02023554
• Lead Sponsor: Zhujiang Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-23
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-30
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-18
• Last Update Posted: 2014-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Theophylline with azithromycin	Theophylline with azithromycin	steady-state plasma concentration of theophylline in the presence of azithromycin
Theophylline alone	Theophylline alone	steady-state plasma concentration of theophylline alone

Primary Outcome Measures

Name	Time	Method
steady-state plasma concentration of theophylline	blood samples for theophylline will be collected on Days 8 and 15 before dosing	Theophylline and it's metabolite(1,3-dimethyluric) blood concentration

Trial Locations

Locations (1)

Zhujiang Hospital,Southern Medical Universtiy; 🇨🇳 Guangzhou, Guangdong, China