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

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Sweden

Study Type

Interventional

Intervention

Pulmicort (budesonide) Turbuhaler

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

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

Full Information

NCT ID

NCT00228475

First Posted

September 27, 2005

Last Updated

January 21, 2011

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00228475

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

September 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

8 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Pulmicort (budesonide) Turbuhaler

Primary Outcome Measure Information:

Title

The concentration of budesonide in breast milk from asthmatic women

Title

on maintenance treatment with Pulmicort Turbuhaler

Secondary Outcome Measure Information:

Title

Level of budesonide to the infant from breast milk concentrations

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

AstraZeneca RITA Clinical Department

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

Facility Information:

City

Uppsala

Country

Sweden

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial