Trial Outcomes & Findings for Safety and Efficacy Study of Budesonide (Pulmicort®) Turbuhaler® in Japanese Children With Bronchial Asthma (NCT NCT00509028)
NCT ID: NCT00509028
Last Updated: 2012-08-27
Results Overview
AEs were defined as undesirable medical conditions or deteriorations of a pre-existing medical condition following/during exposure. All Serious AEs, AEs leading to withdrawal, Other relevant AE were recorded.
COMPLETED
PHASE3
241 participants
54 weeks
2012-08-27
Participant Flow
241 Japanese paediatric patients were enrolled into the study
This was an open-label, multi-centre, long-term study in Japanese children with bronchial asthma aged 5 to 15 years, and conducted as an extension of the Phase III study D5254C00769.
Participant milestones
| Measure |
Budesonide
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
|
Conventional Therapy
According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
|
|---|---|---|
|
Overall Study
STARTED
|
121
|
120
|
|
Overall Study
COMPLETED
|
109
|
113
|
|
Overall Study
NOT COMPLETED
|
12
|
7
|
Reasons for withdrawal
| Measure |
Budesonide
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
|
Conventional Therapy
According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Protocol Violation
|
4
|
2
|
|
Overall Study
Non-compliance
|
2
|
1
|
Baseline Characteristics
Safety and Efficacy Study of Budesonide (Pulmicort®) Turbuhaler® in Japanese Children With Bronchial Asthma
Baseline characteristics by cohort
| Measure |
Budesonide
n=121 Participants
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
|
Conventional Therapy
n=120 Participants
According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
|
Total
n=241 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
8.9 Years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
8.6 Years
STANDARD_DEVIATION 2.3 • n=7 Participants
|
8.8 Years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 54 weeksAEs were defined as undesirable medical conditions or deteriorations of a pre-existing medical condition following/during exposure. All Serious AEs, AEs leading to withdrawal, Other relevant AE were recorded.
Outcome measures
| Measure |
Budesonide
n=121 Participants
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
|
Conventional Therapy
n=120 Participants
According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
|
|---|---|---|
|
Number of Patients With Adverse Events (AEs).
|
118 Participants
|
116 Participants
|
SECONDARY outcome
Timeframe: 54 weeksAnalysis of haematological, clinical chemistry and urynalysis variables were performed. Haematology variables: erythrocytes, haemoglobin, haematocrit, leucocyte count, leucocyte different count (neutrophils, eosinophils, basophils, lymphocytes, monocytes), platelet count. Clinical chemistry measurements: aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), total bilirubin, albumin, creatinine,sodium, potassium, total protein, blood urea nitrogen. Urinalysis variables: protein, glucose, urobilinogen, occult.
Outcome measures
| Measure |
Budesonide
n=121 Participants
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
|
Conventional Therapy
n=120 Participants
According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
|
|---|---|---|
|
Number of Patients With Abnormal Clinical Laboratory Test Values.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 54 weeksOutcome measures
| Measure |
Budesonide
n=121 Participants
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
|
Conventional Therapy
n=120 Participants
According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
|
|---|---|---|
|
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 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 54 weeksCut-off value of cortisol is defined as 4 mcg/dL.
Outcome measures
| Measure |
Budesonide
n=121 Participants
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
|
Conventional Therapy
n=120 Participants
According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
|
|---|---|---|
|
Number of Patients With Abnormal Plasma Cortisol Values.
|
20 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline and 54 weeksHeight, change from baseline calculated as (height at last visit - height at randomization)
Outcome measures
| Measure |
Budesonide
n=109 Participants
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
|
Conventional Therapy
n=113 Participants
According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
|
|---|---|---|
|
Height
|
5.34 Centimeters
Standard Deviation 1.99
|
6.35 Centimeters
Standard Deviation 1.89
|
SECONDARY outcome
Timeframe: Baseline and 54 weeksWeight, change from baseline calculated as (weight at last visit - weight at randomization)
Outcome measures
| Measure |
Budesonide
n=109 Participants
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
|
Conventional Therapy
n=113 Participants
According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
|
|---|---|---|
|
Weight
|
3.78 kilograms
Standard Deviation 2.77
|
4.39 kilograms
Standard Deviation 3.22
|
SECONDARY outcome
Timeframe: 54 weeksChange in PEF percent of predicted normal calculated as (PEF percent predicted normal at last visit - PEF percent predicted normal at randomization).
Outcome measures
| Measure |
Budesonide
n=121 Participants
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
|
Conventional Therapy
n=120 Participants
According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
|
|---|---|---|
|
Morning Peak Expiratory Flow (PEF) Percentage of Predicted Normal
|
9.54 Percentage
Standard Deviation 19.87
|
5.84 Percentage
Standard Deviation 17.81
|
SECONDARY outcome
Timeframe: Baseline and 54 weeksChange in respiratory condition at asthma attacks (daytime) from baseline to last visit. Scale: 0 - 4. 0 = None. 1 = Mild. 2 = Moderate. 3= Severe. 4 = Respiratory insufficiency
Outcome measures
| Measure |
Budesonide
n=121 Participants
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
|
Conventional Therapy
n=119 Participants
According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
|
|---|---|---|
|
Change From Baseline of Respiratory Condition at Asthma Attacks (Daytime)
|
-0.139 Points on a scale
Standard Deviation 0.334
|
-0.156 Points on a scale
Standard Deviation 0.302
|
SECONDARY outcome
Timeframe: Baseline and 54 weeksChange in respiratory condition at asthma attacks (nighttime) from baseline calculated as (respiratory condition at asthma attacks (nighttime) at last visit - respiratory condition at asthma attacks (night-time) at randomization). Scale: 0 - 4. 0 = None. 1 = Mild. 2 = Moderate. 3= Severe. 4 = Respiratory insufficiency.
Outcome measures
| Measure |
Budesonide
n=121 Participants
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
|
Conventional Therapy
n=119 Participants
According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
|
|---|---|---|
|
Change From Baseline of Respiratory Condition at Asthma Attacks (Nighttime)
|
-0.12 Points on a scale
Standard Deviation 0.29
|
-0.147 Points on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Baseline and 54 weeksChange in use of inhaled short-acting B-2 agonist (daytime) from baseline calculated as (use of inhaled short-acting B-2 agonist (daytime) at last visit - use of inhaled short-acting B-2 agonist (daytime) at randomization)
Outcome measures
| Measure |
Budesonide
n=121 Participants
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
|
Conventional Therapy
n=119 Participants
According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
|
|---|---|---|
|
Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Daytime)
|
-0.21 Puffs per day
Standard Deviation 0.647
|
-0.242 Puffs per day
Standard Deviation 0.485
|
SECONDARY outcome
Timeframe: Baseline and 54 weeksChange in use of inhaled short-acting B-2 agonist (night-time) from baseline calculated as (use of inhaled short-acting B-2 agonist (night-time) at last visit - use of inhaled short-acting B-2 agonist (night-time) at randomization)
Outcome measures
| Measure |
Budesonide
n=121 Participants
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
|
Conventional Therapy
n=119 Participants
According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
|
|---|---|---|
|
Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Night-time)
|
-0.07 Puffs per day
Standard Deviation 0.415
|
-0.097 Puffs per day
Standard Deviation 0.368
|
SECONDARY outcome
Timeframe: Baseline and 54 weeksChange in disturbance of daily activities from baseline calculated as (disturbance of daily activities at last visit - disturbance of daily activities at randomization). Frequency of disturbance of daily activity was assessed using 3- grade scale (normal, almost able, unable).
Outcome measures
| Measure |
Budesonide
n=121 Participants
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
|
Conventional Therapy
n=119 Participants
According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
|
|---|---|---|
|
Change From Baseline in Disturbance of Daily Activities
|
-0.037 Disturbances per day
Standard Deviation 0.141
|
-0.017 Disturbances per day
Standard Deviation 0.141
|
SECONDARY outcome
Timeframe: Baseline and 54 weeksChange in disturbance of night-time sleep from baseline calculated as (disturbances of night-time sleep at last visit - disturbances of night-time sleep at randomization). Frequency of disturbance of night- time sleep was assessed using 3- grade scale (normal, almost able, unable).
Outcome measures
| Measure |
Budesonide
n=121 Participants
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
|
Conventional Therapy
n=119 Participants
According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
|
|---|---|---|
|
Change From Baseline in Disturbance of Night-time Sleep
|
-0.029 Disturbances per night
Standard Deviation 0.134
|
-0.042 Disturbances per night
Standard Deviation 0.132
|
SECONDARY outcome
Timeframe: 54 weeksForced Expiratory Volume in one second (FEV1) percentage of predicted normal change from baseline calculated as: 100 \* (FEV1 at last visit - FEV1 at randomization)/predicted normal FEV1).
Outcome measures
| Measure |
Budesonide
n=121 Participants
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
|
Conventional Therapy
n=120 Participants
According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
|
|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1) Percentage of Predicted Normal Change From Baseline
|
1.5 Percentage
Standard Deviation 15.59
|
2.31 Percentage
Standard Deviation 16.63
|
Adverse Events
Budesonide
Conventional Therapy
Serious adverse events
| Measure |
Budesonide
n=121 participants at risk
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
|
Conventional Therapy
n=120 participants at risk
According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.1%
5/121
|
5.0%
6/120
|
|
Infections and infestations
Adenoviral conjunctivitis
|
0.83%
1/121
|
0.00%
0/120
|
|
Infections and infestations
Appendicitis
|
0.83%
1/121
|
0.00%
0/120
|
|
Infections and infestations
Gastroenteritis
|
0.83%
1/121
|
0.00%
0/120
|
|
Infections and infestations
Influenza
|
0.83%
1/121
|
0.00%
0/120
|
|
Infections and infestations
Pneumonia
|
0.83%
1/121
|
1.7%
2/120
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.83%
1/121
|
0.00%
0/120
|
|
Infections and infestations
Enterocolitis bacterial
|
0.83%
1/121
|
0.00%
0/120
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/121
|
0.83%
1/120
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/121
|
2.5%
3/120
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/121
|
0.83%
1/120
|
|
Vascular disorders
Hypotension
|
0.00%
0/121
|
0.83%
1/120
|
Other adverse events
| Measure |
Budesonide
n=121 participants at risk
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
|
Conventional Therapy
n=120 participants at risk
According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
|
|---|---|---|
|
Eye disorders
Conjunctivitis Allergic
|
12.4%
15/121
|
16.7%
20/120
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
56.2%
68/121
|
50.0%
60/120
|
|
Infections and infestations
Bronchitis
|
33.1%
40/121
|
38.3%
46/120
|
|
Infections and infestations
Pharyngitis
|
29.8%
36/121
|
33.3%
40/120
|
|
Infections and infestations
Gastroenteritis
|
23.1%
28/121
|
25.0%
30/120
|
|
Infections and infestations
Influenza
|
24.8%
30/121
|
22.5%
27/120
|
|
Infections and infestations
Nasopharyngitis
|
19.0%
23/121
|
17.5%
21/120
|
|
Infections and infestations
Otitis Media
|
12.4%
15/121
|
12.5%
15/120
|
|
Infections and infestations
Chronic Sinusitis
|
11.6%
14/121
|
8.3%
10/120
|
|
Infections and infestations
Acute Tonsillitis
|
8.3%
10/121
|
7.5%
9/120
|
|
Infections and infestations
Impetigo
|
6.6%
8/121
|
7.5%
9/120
|
|
Infections and infestations
Hordeolum
|
0.00%
0/121
|
5.0%
6/120
|
|
Injury, poisoning and procedural complications
Contusion
|
6.6%
8/121
|
7.5%
9/120
|
|
Nervous system disorders
Headache
|
8.3%
10/121
|
9.2%
11/120
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
21.5%
26/121
|
18.3%
22/120
|
|
Skin and subcutaneous tissue disorders
Eczema
|
9.1%
11/121
|
13.3%
16/120
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
8.3%
10/121
|
10.0%
12/120
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
5.0%
6/121
|
5.0%
6/120
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
1.7%
2/121
|
5.0%
6/120
|
|
Skin and subcutaneous tissue disorders
Heat Rash
|
2.5%
3/121
|
5.0%
6/120
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60