Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation

This study has been completed.
Information provided by (Responsible Party):
ClinicalTrials.gov 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 ] [ Designated as safety issue: Yes ]
  • Effects on growth rate [ Time Frame: Range of 3 years ] [ Designated as safety issue: Yes ]
    Variation of the height/weight from the baseline.

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

  • Effects on development of infections. [ Time Frame: Range of 3 years ] [ Designated as safety issue: Yes ]
    Existence and type of infections.

Secondary Outcome Measures:
  • Clinical course under Pulmicort long-term use [ Designated as safety issue: No ]
    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
Genders Eligible for Study:   Both
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 ClinicalTrials.gov identifier: NCT01232322

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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01232322     History of Changes
Other Study ID Numbers: D5257L00014 
Study First Received: October 31, 2010
Last Updated: January 23, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

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

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 02, 2016