Drug Interaction Study of Azithromycin and Theophylline
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| ClinicalTrials.gov Identifier: NCT02023554 |
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Recruitment Status :
Completed
First Posted : December 30, 2013
Last Update Posted : August 19, 2014
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Sponsor:
Zhujiang Hospital
Information provided by (Responsible Party):
Zhujiang Hospital
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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 |
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.
| 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 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Theophylline with azithromycin
steady-state plasma concentration of theophylline in the presence of azithromycin
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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. |
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Active Comparator: Theophylline alone
steady-state plasma concentration of theophylline alone
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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 :
- 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
| China, Guangdong | |
| Zhujiang Hospital,Southern Medical Universtiy | |
| Guangzhou, Guangdong, China, 510282 | |
Sponsors and Collaborators
Zhujiang Hospital
Investigators
| Principal Investigator: | Liqing Wang, Doctor | Zhujiang Hospital,Southern Medical Unversity |
| 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:
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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 |