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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00228475
First received: September 27, 2005
Last updated: January 21, 2011
Last verified: January 2011
History of Changes
  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
Endpoint Classification: Pharmacokinetics Study
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:

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide
U.S. FDA Resources

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

Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00228475

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

No publications provided

ClinicalTrials.gov Identifier: NCT00228475     History of Changes
Other Study ID Numbers: D5254C00763
Study First Received: September 27, 2005
Last Updated: January 21, 2011
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 21, 2013