A Study to Assess the Concentration of Budesonide in Breast Milk From Asthmatic Women

Condition(s) targeted: Asthma

Intervention: Pulmicort (budesonide) Turbuhaler (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca RITA Clinical Department, Study Director, Affiliation: AstraZeneca AB

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.

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

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Primary outcome:

The concentration of budesonide in breast milk from asthmatic women

on maintenance treatment with Pulmicort Turbuhaler

Secondary outcome: Level of budesonide to the infant from breast milk concentrations

Minimum age: N/A. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Uppsala, Sweden

Starting date: September 2004
Last updated: November 21, 2006