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Long Term Safety & Efficacy of Budesonide Inhalation Suspension in Japanese Children With Bronchial Asthma

This study has been completed.

Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00232648
  Purpose

This study is as an extension study of SD-004-0765, to assess the safety profile of long-term use of budesonide inhalation suspension in Japanese young children with bronchial asthma. Children completing study SD-004-0765 continued administration of budesonide inhalation suspension as judged by the investigator; the dose is adjusted as appropriate within the range of 0.25 to 1.0 mg per day administered once or twice daily, according to the symptoms.


Condition Intervention Phase
Asthma
Drug: Pulmicort (budesonide) Respules
Phase III

MedlinePlus related topics:   Asthma   

ChemIDplus related topics:   Budesonide   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Investigation of Safety and Efficacy of Budesonide Inhalation Suspension in the Long-Term Use in Japanese Children With Bronchial Asthma (Open Long-Term Extension Study Following Study SD-004-0765

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The safety profile of long-term use of budesonide inhalation suspension assessed by evaluation of frequency and intensity of adverse events, plasma cortisol, physical examination, height, weight and clinical laboratory values.

Secondary Outcome Measures:
  • The efficacy of budesonide inhalation suspension assessed by overall evaluation on asthma control by investigator

Estimated Enrollment:   54
Study Start Date:   January 2004
Study Completion Date:   February 2007
Primary Completion Date:   November 2006 (Final data collection date for primary outcome measure)

  Eligibility
Ages Eligible for Study:   13 Months to 65 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

- 1. Clinical benefit from continued treatment with budesonide inhalation suspension was expected in patients with bronchial asthma participating in study SD-004-0765, as judged by the investigator(s) at the completion of that study (Visit 11, Week 24), and the patient's caregiver wished the continued treatment with budesonide inhalation suspension A written consent to participate in this study had been obtained from the patient's legal representative (a person who exercises parental authority for the patient, or if no one was applicable, a guardian: in principle, the patient's parent).

3. The patient was younger than 5 years old. Patients aged 5 years could be included in this study if no other effective treatment for the patient's bronchial asthma was available as judged by the investigator(s).

Exclusion Criteria:

-1. Concurrent severe diseases of liver, kidney, heart or other complications. 2. Contra-indications (eg, known or suspected allergy) to budesonide or excipients contained in the investigational product.

3. Other conditions, in which the investigator(s) judges patient's participation in this study inappropriate.

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232648

Locations
Japan
      Kanagawa, Japan
      Obhu-city, Japan
      Hioshima, Japan
      Matsuyama City, Japan
      Tokyo, Japan
Japan, Fukuoka
      Fukuoka-City, Fukuoka, Japan
Japan, Kanagawa
      Isehara-City, Kanagawa, Japan
Japan, Mie
      Tsu-City, Mie, Japan
Japan, Okayama
      Kurashiki City, Okayama, Japan

Sponsors and Collaborators
AstraZeneca

Investigators
Study Director:     AstraZeneca KK RITA Medical Director     AstraZeneca KK - Pharmaceuticals    
  More Information


Study ID Numbers:   SD-004-0768
First Received:   September 30, 2005
Last Updated:   January 11, 2008
ClinicalTrials.gov Identifier:   NCT00232648
Health Authority:   Japan: Pharmaceuticals and Medical Devices Agency

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Budesonide
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

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

ClinicalTrials.gov processed this record on October 03, 2008




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