Phase 3
Completed N=241
Safety and Efficacy Study of Budesonide (Pulmicort®) Turbuhaler® in Japanese Children With Bronchial Asthma
Source: ClinicalTrials.gov NCT00509028 ↗Enrolled (actual)
241
Serious AEs
8.7%
Results posted
Aug 2012
Primary outcomePrimary: Number of Patients With Adverse Events (AEs). — 118; 116 Participants
Summary
This study will include the patients who are Japanese children with bronchial asthma aged 5 years to 15 years old and have completed the Phase III study (Study code: D5254C00769) at about 29 centres. To investigate the safety of budesonide Turbuhaler® with a daily dose of 100 µg to 800 µg for 54 weeks treatment including the prior 6 weeks Phase III study (Study D5254C00769, NCT00504062) as compared with conventional therapy in Japanese children with bronchial asthma in need of inhaled glucocorticosteroid treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Adverse Events (AEs). |
118; 116 | — |
| SECONDARY Number of Patients With Abnormal Clinical Laboratory Test Values. |
0; 0 | — |
| SECONDARY Number of Patients With Abnormal Vital Sign Values for the Following Variables: Blood Pressure (Sitting) and Pulse Rate (Sitting), as Judged by the Investigator |
0; 0 | — |
| SECONDARY Number of Patients With Abnormal Plasma Cortisol Values. |
20; 12 | — |
| SECONDARY Height |
5.34; 6.35 | — |
| SECONDARY Weight |
3.78; 4.39 | — |
| SECONDARY Morning Peak Expiratory Flow (PEF) Percentage of Predicted Normal |
9.54; 5.84 | — |
| SECONDARY Change From Baseline of Respiratory Condition at Asthma Attacks (Daytime) |
-0.139; -0.156 | — |
| SECONDARY Change From Baseline of Respiratory Condition at Asthma Attacks (Nighttime) |
-0.12; -0.147 | — |
| SECONDARY Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Daytime) |
-0.21; -0.242 | — |
| SECONDARY Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Night-time) |
-0.07; -0.097 | — |
| SECONDARY Change From Baseline in Disturbance of Daily Activities |
-0.037; -0.017 | — |
| SECONDARY Change From Baseline in Disturbance of Night-time Sleep |
-0.029; -0.042 | — |
| SECONDARY Forced Expiratory Volume in One Second (FEV1) Percentage of Predicted Normal Change From Baseline |
1.5; 2.31 | — |
Eligibility Criteria
Inclusion Criteria
- Patient who complete preceding the Phase III study and provide a signed written informed consent by patient's legal representative at Visit 1 or 4 weeks prior to Visit 1 of the study. A signed written informed assent should also be obtained from the patients themselves as much as possible
- When the investigator will obtain the signed written informed consent of Phase III study (D5254C00769) from patient's legal representative, the investigator will also provide the information of this study
Exclusion Criteria
- Respiratory infections that, in the opinion of the investigator(s), may affect the efficacy evaluation e.g., lower airways infection such as pneumonia, infection with no available effective antimicrobial drugs or with deep seated mycosis
- Concurrent serious diseases of liver, kidney, heart or other complications which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patient's ability to participate in the study. Any clinically relevant abnormal findings in vital sign or physical examination at Visit 1 in this study, which in the opinion of the investigator may put the patient at risk because of his/her participation in the study.
- Pregnant or possible pregnancy or planning to become pregnant during the study period
- Other subjects who are considered inappropriate to participate in this study judged by the investigator
Data sourced from ClinicalTrials.gov (NCT00509028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.