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Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: October 31, 2010
Last updated: January 23, 2013
Last verified: January 2013
The purpose of this study is to investigate the safety and efficacy for long term treatment of the drug in children aged 6 months and < 5 years on bronchial asthma in daily clinical usage.

Bronchial Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation for Long-term Use in Pediatrics

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Incidence of Adverse Events [ Time Frame: Range of 3 years ]
  • Effects on growth rate [ Time Frame: Range of 3 years ]
    Variation of the height/weight from the baseline.

  • Effects on the adrenal cortical function. [ Time Frame: Range of 3 years ]
    Symptoms of adrenal cortical function suppression before and after the treatment with Pulmicort.

  • Effects on development of infections. [ Time Frame: Range of 3 years ]
    Existence and type of infections.

Secondary Outcome Measures:
  • Clinical course under Pulmicort long-term use
    Validation of the frequency of asthmatic attack, level of the asthmatic attack, daily life, night sleep from baseline

Enrollment: 633
Study Start Date: October 2006
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Pulmicort Respules
Those with an exposure


Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated with Pulmicort respules for the first time due to bronchial asthma and children of >=6months and <5 years old age at the start of study treatment

Inclusion Criteria:

  • Patients treated with Pulmicort Respules for the first time due to bronchial asthma
  • Children of >= 6 months and < 5 years old age at the start of study treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01232322

Sponsors and Collaborators
Study Director: Yoshida Shigeru, MD AstraZeneca K.K.
  More Information

Responsible Party: AstraZeneca Identifier: NCT01232322     History of Changes
Other Study ID Numbers: D5257L00014
Study First Received: October 31, 2010
Last Updated: January 23, 2013

Keywords provided by AstraZeneca:
bronchial asthma
Pulmicort Respules
long term use

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on May 23, 2017