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Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01232322
First Posted: November 2, 2010
Last Update Posted: January 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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:


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)
Groups/Cohorts
Pulmicort Respules
Those with an exposure

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01232322


Sponsors and Collaborators
AstraZeneca
Investigators
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
First Submitted: October 31, 2010
First Posted: November 2, 2010
Last Update Posted: January 24, 2013
Last Verified: January 2013

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
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists