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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00228475
First Posted: September 29, 2005
Last Update Posted: January 24, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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
Asthma Drug: Pulmicort (budesonide) Turbuhaler Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228475


Locations
Sweden
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca RITA Clinical Department AstraZeneca
  More Information

ClinicalTrials.gov Identifier: NCT00228475     History of Changes
Other Study ID Numbers: D5254C00763
First Submitted: September 27, 2005
First Posted: September 29, 2005
Last Update Posted: January 24, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists