A Study to Assess the Concentration of Budesonide in Breast Milk From Asthmatic Women
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 budesonide to infants...
Brief Summary
Official Title: “An Open Single Centre Study to Assess the Concentration of Budesonide in Breast Milk From Asthmatic Women on Maintenance Treatment w/Pulmicort ® Turbuhaler ® at the Dose Levels 200/400 µg Bid”
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 budesonide to infants.
- Study Type: Interventional
- Study Design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Pulmicort (budesonide) Turbuhaler
Outcome Measures for this Clinical Trial
Primary Measures
- The concentration of budesonide in breast milk from asthmatic women
- on maintenance treatment with Pulmicort Turbuhaler
Secondary Measures
- Level of budesonide to the infant from breast milk concentrations
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- 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 Criteria:
- 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
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
AstraZeneca RITA Clinical Department Study Director AstraZeneca AB
Additional Information
Information obtained from ClinicalTrials.gov on February 08, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00228475
Study ID Number: D5254C00763
ClinicalTrials.gov Identifier: NCT00228475
Health Authority: Sweden: Medical Products Agency
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00228475
