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...

Date First Received: September 27, 2005

Last Updated: March 24, 2009

Verified by: AstraZeneca, March 2009

Clinical Trial Phase: Phase 1 | Start Date: September 2004

Overall Status: Completed

Estimated Enrollment: 8

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”

Condition Keyword(s):

Additional Keyword(s) Provided by Sponsor:

    Condition MeSH Term(s), Assigned with an Experimental Algorithm:

    Intervention MeSH Term(s), Assigned with an Experimental Algorithm:

    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, Control: Uncontrolled, 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 Sponsor Information

    Lead Sponsor: AstraZeneca

    Overall Clinical Trial Officials and Contacts

    AstraZeneca RITA Clinical Department Study Director AstraZeneca AB  

    Additional Information

    Information obtained from ClinicalTrials.gov on September 07, 2010

    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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