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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2005-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pulmicort (budesonide) Turbuhaler

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No