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Drug Interaction Study of Azithromycin and Theophylline

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ClinicalTrials.gov Identifier: NCT02023554
Recruitment Status : Completed
First Posted : December 30, 2013
Last Update Posted : August 19, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Asthma Drug: Theophylline with azithromycin Drug: Theophylline alone Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Study Start Date : December 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014


Arm Intervention/treatment
Experimental: Theophylline with azithromycin
steady-state plasma concentration of theophylline in the presence of azithromycin
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.


Active Comparator: Theophylline alone
steady-state plasma concentration of theophylline alone
Drug: 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.




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02023554


Locations
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China, Guangdong
Zhujiang Hospital,Southern Medical Universtiy
Guangzhou, Guangdong, China, 510282
Sponsors and Collaborators
Zhujiang Hospital
Investigators
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Principal Investigator: Liqing Wang, Doctor Zhujiang Hospital,Southern Medical Unversity
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Responsible Party: Zhujiang Hospital
ClinicalTrials.gov Identifier: NCT02023554    
Other Study ID Numbers: 81302846-1
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: August 19, 2014
Last Verified: August 2014
Keywords provided by Zhujiang Hospital:
azithromycin
theophylline
CYP3A4
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases
Azithromycin
Theophylline
Anti-Bacterial Agents
Anti-Infective Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents