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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00232648
First received: September 30, 2005
Last updated: March 24, 2009
Last verified: March 2009
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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: November 2006
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
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: NCT00232648

Locations
Japan
Fukuoka-City, Fukuoka, Japan
Isehara-City, Kanagawa, Japan
Tsu-City, Mie, Japan
Kurashiki City, Okayama, Japan
Hioshima, Japan
Kanagawa, Japan
Matsuyama City, Japan
Obhu-city, Japan
Tokyo, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca KK RITA Medical Director AstraZeneca KK - Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00232648     History of Changes
Other Study ID Numbers: SD-004-0768
Study First Received: September 30, 2005
Last Updated: March 24, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on August 20, 2014