Status:
COMPLETED
A Study to Assess the Concentration of Budesonide in Breast Milk From Asthmatic Women
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
FEMALE
Phase:
PHASE4
Brief Summary
The purpose to measure the concentration of budesonide in breast milk of asthmatic mothers on their normal maintenance treatment with budesonide (Pulmicort Turbuhaler), and to estimate the exposure of...
Eligibility Criteria
Inclusion
- Be willing and able to comply with study procedures and provide informed consent.
- Be breast-feeding women, aged 18 to 45 years inclusive, and having infants aged 1 to 6 months.
- Be asthmatics that have been on maintenance treatment with Pulmicort Turbuhaler 200 or 400 µg bid for at least 3 months prior to visit
Exclusion
- Clinically relevant abnormalities in physical examination, laboratory assessments, blood pressure or pulse as judged by the investigator.
- Clinically relevant disease and/or abnormalities, which in the opinion of the investigator, may either put the patient or infant at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study.
- A suspected/manifested infection of HIV, hepatitis B or C or other infection according to WHO Risk classification 2-4
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00228475
Start Date
September 1 2004
End Date
October 1 2005
Last Update
January 24 2011
Active Locations (1)
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1
Uppsala, Sweden