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

This study has been completed.

First Received: September 27, 2005 Last Updated: March 24, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00228475

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 I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
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

Study ID Numbers:	D5254C00763
Study First Received:	September 27, 2005
Last Updated:	March 24, 2009
ClinicalTrials.gov Identifier:	NCT00228475 History of Changes
Health Authority:	Sweden: Medical Products Agency

Study placed in the following topic categories:

Anti-Inflammatory Agents
Hormone Antagonists
Budesonide
Hormones, Hormone Substitutes, and Hormone Antagonists
Asthma
Anti-Asthmatic Agents
Glucocorticoids

Hormones
Naphazoline
Guaifenesin
Phenylpropanolamine
Peripheral Nervous System Agents
Bronchodilator Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Physiological Effects of Drugs
Budesonide
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Glucocorticoids

Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on September 03, 2009