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Completed

NCT Number: NCT00228475

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulmicort (budesonide) Turbuhaler

Drug

Primary outcomes

  1. The concentration of budesonide in breast milk from asthmatic women

  2. on maintenance treatment with Pulmicort Turbuhaler

Secondary outcomes

  1. Level of budesonide to the infant from breast milk concentrations

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2005
First posted
Sep 29, 2005
Registry last updated
Jan 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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