Asthma
Conditions
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 budesonide to infants.
Interventions
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The concentration of budesonide in breast milk from asthmatic women | — |
| on maintenance treatment with Pulmicort Turbuhaler | — |
Secondary
| Measure | Time frame |
|---|---|
| Level of budesonide to the infant from breast milk concentrations | — |
Countries
Sweden
Outcome results
None listed