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Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01232322
First received: October 31, 2010
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
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:

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide
U.S. FDA Resources

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)
Groups/Cohorts
Pulmicort Respules
Those with an exposure

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232322

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

No publications provided

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
pediatrics

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

ClinicalTrials.gov processed this record on June 13, 2013