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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00228475
• Other study ID #: D5254C00763
• Status: Completed
• Phase: Phase 4
• First received: September 27, 2005
• Last updated: January 21, 2011
• Start date: September 2004
• Est. completion date: October 2005

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Pulmicort (budesonide) Turbuhaler

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The concentration of budesonide in breast milk from asthmatic women
Primary	on maintenance treatment with Pulmicort Turbuhaler
Secondary	Level of budesonide to the infant from breast milk concentrations