Asthma
Conditions
Interventions
investigational material(s)
Generic name etc : Pulmicort (budesonide) Respules
INN of investigational material :
Therapeutic category code : 229 Other agents affecting respiratory organs
Dosage and A
Sponsors
AstraZeneca
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Ages Eligible for Study: 13 Months - 65 Months Genders Eligible for Study: Both 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 2. 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. 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety/Efficacy 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. | — |
Outcome results
None listed