Clinical trial NCT00232648: Long Term Safety & Efficacy of Budesonide Inhalation Suspension in Japanese Children With Bronchial Asthma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-05
Enrollment: 54
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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:
measure: The efficacy of budesonide inhalation suspension assessed by overall evaluation on asthma control by investigator
Other outcomes:
Locations:
city: Fukuoka-City
country: Japan
state: Fukuoka
city: Isehara-City
country: Japan
state: Kanagawa
city: Tsu-City
country: Japan
state: Mie
city: Kurashiki City
country: Japan
state: Okayama
city: Hioshima
country: Japan
city: Kanagawa
country: Japan
city: Matsuyama City
country: Japan
city: Obhu-city
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: AstraZeneca KK - Pharmaceuticals
name: AstraZeneca KK RITA Medical Director
role: STUDY_DIRECTOR
References: