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Chronic Obstructive Pulmonary Disease | Drug Interaction Study of Azithromycin and Theophylline

Chronic Obstructive Pulmonary Disease research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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;

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Chronic Obstructive Pulmonary Disease

Asthma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Theophylline with azithromycinDrug: 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.

Drug:Theophylline aloneDrug: 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Theophylline with azithromycinsteady-state plasma concentration of theophylline in the presence of azithromycin

Theophylline alonesteady-state plasma concentration of theophylline alone

Study Status

Completed

Start Date: December 2013

Completed Date: July 2014

Phase: N/A

Type: Interventional

Design:

Primary Outcome: steady-state plasma concentration of theophylline

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Liqing Wang, Doctor

Lead Sponsor: Zhujiang Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02023554

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