Back to resultsDrug Interaction Study of Azithromycin and Theophylline
Primary Purpose
Chronic Obstructive Pulmonary Disease, Asthma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Theophylline with azithromycin
Theophylline alone
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease focused on measuring azithromycin, theophylline, CYP3A4
Eligibility 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;
Sites / Locations
- Zhujiang Hospital,Southern Medical Universtiy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Theophylline with azithromycin
Theophylline alone
Arm Description
steady-state plasma concentration of theophylline in the presence of azithromycin
steady-state plasma concentration of theophylline alone
Outcomes
Primary Outcome Measures
steady-state plasma concentration of theophylline
Theophylline and it's metabolite(1,3-dimethyluric) blood concentration
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02023554
Brief Title
Drug Interaction Study of Azithromycin and Theophylline
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 Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Asthma
Keywords
azithromycin, theophylline, CYP3A4
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Theophylline with azithromycin
Arm Type
Experimental
Arm Description
steady-state plasma concentration of theophylline in the presence of azithromycin
Arm Title
Theophylline alone
Arm Type
Active Comparator
Arm Description
steady-state plasma concentration of theophylline alone
Intervention Type
Drug
Intervention Name(s)
Theophylline with azithromycin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Theophylline alone
Intervention Description
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 Measure Information:
Title
steady-state plasma concentration of theophylline
Description
Theophylline and it's metabolite(1,3-dimethyluric) blood concentration
Time Frame
blood samples for theophylline will be collected on Days 8 and 15 before dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liqing Wang, Doctor
Organizational Affiliation
Zhujiang Hospital,Southern Medical Unversity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhujiang Hospital,Southern Medical Universtiy
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510282
Country
China
12. IPD Sharing Statement
Learn more about this trial
Drug Interaction Study of Azithromycin and Theophylline
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