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

NCT00232648 | Completed Phase 3

• 1 other identifier: SD-004-0768
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The efficacy of budesonide inhalation suspension assessed by overall evaluation on asthma control by investigator

Interventions

Pulmicort (budesonide) Respules DRUG

Eligibility Criteria

• Age: 13 Months - 65 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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).
• \. 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).

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (9)

Unknown Facility

Fukuoka, Fukuoka, Japan

Location

Unknown Facility

Isehara, Kanagawa, Japan

Location

Unknown Facility

Tsu, Mie-ken, Japan

Location

Unknown Facility

Kurashiki, Okayama-ken, Japan

Location

Unknown Facility

Hioshima, Japan

Location

Unknown Facility

Kanagawa, Japan

Location

Unknown Facility

Matsuyama, Japan

Location

Unknown Facility

Obhu-city, Japan

Location

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• AstraZeneca KK RITA Medical Director

  AstraZeneca KK - Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 30, 2005
• First Posted: October 5, 2005
• Study Start: January 1, 2004
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: March 25, 2009

Record last verified: 2009-03

Locations

JP (9)