NCT00228475

CompletedPhase 4

A Study to Assess the Concentration of Budesonide in Breast ...

AstraZeneca Source

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Other study identifiers

Sponsor study identifier

D5254C00763

Study Type

interventional

Reported enrollment (type unavailable)

8

Locations

1 country

Sites

1

Timeline

Study Start

September 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

October 2005

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 8 participants
Study completion date: October 2005
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 2004
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 27, 2005
Actual (reported)
First Posted
September 29, 2005
Actual (reported)
Study Completion
October 2005
Actual (reported)

Last Updated: January 24, 2011
Status Verified: January 2011
Last Update Submitted: January 21, 2011

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (1)

Level of budesonide to the infant from breast milk concentrations

Interventions

Pulmicort (budesonide) TurbuhalerDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

AstraZeneca
Industrylead

Study Sites (1)

Uppsala, Sweden

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanes

Study Officials

AstraZeneca RITA Clinical Department
AstraZeneca
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 29, 2005

Study Start

September 2004

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

October 2005

Actual (reported)

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Phase 4Completed

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Phase 4Completed

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SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)

Phase 4Completed

NCT00641446

Varicella Vaccination With Pulmicort

Phase 4Completed

NCT00522782

Effect of Budesonide on Exhaled Nitric Oxide in Asthmatic Children

Phase 4Completed

NCT00234390

PreAsthmaControl (PAC)

Phase 4Completed

Be asthmatics that have been on maintenance treatment with Pulmicort Turbuhaler 200 or 400 µg bid for at least 3 months prior to visit

You may not qualify if:

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

Contact the study team to confirm eligibility.

Steroids

Fused-Ring Compounds

Polycyclic Compounds

Last Updated

January 24, 2011

Record last verified: 2011-01

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00228475
Data provider: ClinicalTrials.gov
Source updated: 2011-01-24
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:17:30 UTC

Locations

SE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations