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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Theophylline with azithromycin | Experimental | steady-state plasma concentration of theophylline in the presence of azithromycin |
|
| Theophylline alone | Active Comparator | steady-state plasma concentration of theophylline alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| steady-state plasma concentration of theophylline | Theophylline and it's metabolite(1,3-dimethyluric) blood concentration | blood samples for theophylline will be collected on Days 8 and 15 before dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liqing Wang, Doctor | Zhujiang Hospital,Southern Medical Unversity | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhujiang Hospital,Southern Medical Universtiy | Guangzhou | Guangdong | 510282 | China |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D013806 | Theophylline |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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|
| 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. |
|
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |