AsthmaPhase 3NCT00509028
Safety and Efficacy Study of Budesonide (Pulmicort®) Turbuhaler® in Japanese Children With Bronchial Asthma
A Phase 3 study testing Budesonide and Conventional Asthma Therapy in people with Asthma, run by AstraZeneca at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide and Conventional Asthma Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2006to Oct 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Multi-center, Long Term Study to Investigate the Safety and Efficacy of Budesonide Turbuhaler® Treatment for 48 Weeks (Following 6 Weeks Phase III Study) in Japanese Children With Bronchial Asthma Aged 5 Years to 15 Years Old
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.
- Conditions
- Asthma
- Being tested
- Budesonide, Conventional Asthma Therapy
- Keywords
- Asthma, Bronchial
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
Also called Pulmicort® Turbuhaler®
Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily
Conventional Asthma TherapyDrug
According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
| Study group | Role | What they receive |
|---|---|---|
| BUD - Budesonide | Experimental | Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily Receives: Drug: Budesonide |
| CONV - Conventional Asthma Therapy | Active comparator | Conventional Asthma Therapy - according to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator. Receives: Drug: Conventional Asthma Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Adverse Events (AEs).
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.
Measured: 54 weeks
Secondary outcomes (13)
Number of Patients With Abnormal Clinical Laboratory Test Values.
Analysis 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.
Measured: 54 weeks
Number of Patients With Abnormal Vital Sign Values for the Following Variables: Blood Pressure (Sitting) and Pulse Rate (Sitting), as Judged by the Investigator
Measured: 54 weeks
Number of Patients With Abnormal Plasma Cortisol Values.
Cut-off value of cortisol is defined as 4 mcg/dL.
Measured: 54 weeks
Height
Height, change from baseline calculated as (height at last visit - height at randomization)
Measured: Baseline and 54 weeks
Weight
Weight, change from baseline calculated as (weight at last visit - weight at randomization)
Measured: Baseline and 54 weeks
Morning Peak Expiratory Flow (PEF) Percentage of Predicted Normal
Change in PEF percent of predicted normal calculated as (PEF percent predicted normal at last visit - PEF percent predicted normal at randomization).
Measured: 54 weeks
Change From Baseline of Respiratory Condition at Asthma Attacks (Daytime)
Change 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
Measured: Baseline and 54 weeks
Change From Baseline of Respiratory Condition at Asthma Attacks (Nighttime)
Change 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.
Measured: Baseline and 54 weeks
Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Daytime)
Change 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)
Measured: Baseline and 54 weeks
Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Night-time)
Change 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)
Measured: Baseline and 54 weeks
Change From Baseline in Disturbance of Daily Activities
Change 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).
Measured: Baseline and 54 weeks
Change From Baseline in Disturbance of Night-time Sleep
Change 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).
Measured: Baseline and 54 weeks
Forced Expiratory Volume in One Second (FEV1) Percentage of Predicted Normal Change From Baseline
Forced 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).
Measured: 54 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2007 (estimated)
- Study startDec 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lars-Goran Carlsson, MD, Study director, AstraZeneca R&D Lund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509028
- Sponsor's protocol ID
- D5254C00006
- Status last verified
- Jul 2012
- First submitted
- 17 Jul 2007
- Last updated
- 27 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Long Term Study to Investigate the Safety and Efficacy of Budesonide Turbuhaler® Treatment for 48 Weeks (Following 6 Weeks Phase III Study) in Japanese Children With Bronchial Asthma Aged 5 Years to 15 Years Old
- ClinicalTrials.gov ID
- NCT00509028
- Acronym / sponsor ID
- D5254C00006
- Conditions
- Asthma
- Keywords
- Asthma, Bronchial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 31 Jul 2007 (estimated)
- Results
- Posted 27 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BUD - Budesonide | Experimental | Drug: BudesonideBudesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily |
| CONV - Conventional Asthma Therapy | Active comparator | Drug: Conventional Asthma TherapyConventional Asthma Therapy - according to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BudesonideAlso: Pulmicort® Turbuhaler®Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily | Drug | BUD - Budesonide |
| Conventional Asthma TherapyAccording to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator. | Drug | CONV - Conventional Asthma Therapy |
Primary outcome
Number of Patients With Adverse Events (AEs).
Time frame: 54 weeks
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.
13 secondary outcomes
Number of Patients With Abnormal Clinical Laboratory Test Values.
Time frame: 54 weeks
Number of Patients With Abnormal Vital Sign Values for the Following Variables: Blood Pressure (Sitting) and Pulse Rate (Sitting), as Judged by the Investigator
Time frame: 54 weeks
Number of Patients With Abnormal Plasma Cortisol Values.
Time frame: 54 weeks
Height
Time frame: Baseline and 54 weeks
Weight
Time frame: Baseline and 54 weeks
Morning Peak Expiratory Flow (PEF) Percentage of Predicted Normal
Time frame: 54 weeks
Change From Baseline of Respiratory Condition at Asthma Attacks (Daytime)
Time frame: Baseline and 54 weeks
Change From Baseline of Respiratory Condition at Asthma Attacks (Nighttime)
Time frame: Baseline and 54 weeks
Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Daytime)
Time frame: Baseline and 54 weeks
Change From Baseline of Use of Inhaled Short-acting B-2 Agonist (Night-time)
Time frame: Baseline and 54 weeks
Change From Baseline in Disturbance of Daily Activities
Time frame: Baseline and 54 weeks
Change From Baseline in Disturbance of Night-time Sleep
Time frame: Baseline and 54 weeks
Forced Expiratory Volume in One Second (FEV1) Percentage of Predicted Normal Change From Baseline
Time frame: 54 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars-Goran Carlsson, MD study director
AstraZeneca R&D Lund
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide and Conventional Asthma Therapy in people with Asthma, run by AstraZeneca at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Adverse Events (AEs). (time frame: 54 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2012.