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Drug Interaction Study of Azithromycin and Theophylline

Z

Zhujiang Hospital

Status

Completed

Conditions

Asthma
Chronic Obstructive Pulmonary Disease

Treatments

Drug: Theophylline alone
Drug: Theophylline with azithromycin

Study type

Interventional

Funder types

Other

Identifiers

NCT02023554
81302846-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Theophylline with azithromycin
Experimental group
Description:
steady-state plasma concentration of theophylline in the presence of azithromycin
Treatment:
Drug: Theophylline with azithromycin
Theophylline alone
Active Comparator group
Description:
steady-state plasma concentration of theophylline alone
Treatment:
Drug: Theophylline alone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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