Drug Interaction Study of Azithromycin and Theophylline

Asthma Clinical Trial

Official title:

A Pharmacokinetic Drug Interaction Study to Evaluate the Effect of Azithromycin on the Steady-State Plasma Levels of Theophylline in a Chinese Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023554
• Other study ID #: 81302846-1
• Status: Completed
• Phase: N/A
• First received: December 23, 2013
• Last updated: August 18, 2014
• Start date: December 2013
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Zhujiang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Theophylline with azithromycin
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 alone
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.

Locations

Country	Name	City	State
China	Zhujiang Hospital,Southern Medical Universtiy	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	steady-state plasma concentration of theophylline	Theophylline and it's metabolite(1,3-dimethyluric) blood concentration	blood samples for theophylline will be collected on Days 8 and 15 before dosing	No