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Completed

NCT Number: NCT02023554

Drug Interaction Study of Azithromycin and Theophylline

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Theophylline with azithromycin

Drug

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

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.

Primary outcomes

  1. steady-state plasma concentration of theophylline

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

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

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 30, 2013
Registry last updated
Aug 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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