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

Tracking Information

First Received Date ^ICMJE

September 27, 2005

Last Updated Date

March 24, 2009

Start Date ^ICMJE

September 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The concentration of budesonide in breast milk from asthmatic women
on maintenance treatment with Pulmicort Turbuhaler

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00228475 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Level of budesonide to the infant from breast milk concentrations

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: Pulmicort (budesonide) Turbuhaler

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT ID ^ICMJE

NCT00228475

Responsible Party

Study ID Numbers ^ICMJE

D5254C00763

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

AstraZeneca RITA Clinical Department

AstraZeneca AB

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP