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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: September 27, 2005
Last updated: January 21, 2011
Last verified: January 2011
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.

Condition Intervention Phase
Drug: Pulmicort (budesonide) Turbuhaler
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The concentration of budesonide in breast milk from asthmatic women
  • on maintenance treatment with Pulmicort Turbuhaler

Secondary Outcome Measures:
  • Level of budesonide to the infant from breast milk concentrations

Estimated Enrollment: 8
Study Start Date: September 2004
Study Completion Date: October 2005

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts 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
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Please refer to this study by its identifier: NCT00228475

Uppsala, Sweden
Sponsors and Collaborators
Study Director: AstraZeneca RITA Clinical Department AstraZeneca
  More Information Identifier: NCT00228475     History of Changes
Other Study ID Numbers: D5254C00763
Study First Received: September 27, 2005
Last Updated: January 21, 2011

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on April 26, 2017