AsthmaPhase 3NCT00504062
Open-label, Safety and Efficacy Study of Pulmicort® Turbuhaler® in Japanese Children With Bronchial Asthma
A Phase 3 study testing budesonide and fluticasone in people with Asthma, run by AstraZeneca at 1 site in Japan.
Trial summary
To investigate the effect and safety of budesonide Turbuhaler® 100 μg/dose and 200 μg/dose twice daily for 6 weeks in Japanese children with bronchial asthma aged 5 years to 15 years old in need for inhaled glucocorticosteroid treatment. 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 fluticasone
- How many people
- 240 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2006to Oct 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Provision of signed written informed consent by patient's legal representative; when possible a signed written informed consent should be obtained from the patient themselves
- Patients diagnosed as having bronchial asthma regardless of type of asthma i.e. perennial or seasonal, atopic or non-atopic
- Males/females 5-15 yrs old who are able to experience to inhale with turbuhaler and diskus. the investigator will check whether the patient can inhale appropriately using training devises and "Turbuhaler trainer"
- Patients with bronchial asthma who require treatment with inhaled steroids (patients with drug therapy, in whom asthma is poorly controlled)
- Patients who are already treated with inhaled GCS should have at least 3 months prehistory of asthma before obtaining the written informed consent
Who cannot join
- Use of regular(more than 3 days) systemic (oral, intravenous or intramuscular) steroids within 30 days before the observation period
- The daily dose of inhaled GCS within 30 days before the observation period for the patients who are already treated with inhaled GCS is beyond fluticasone propionate (FP) 200 µg/day or beclomethasone dipropionate (BDP) 200 μg/day.
- 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 within 30 days before the observation period.
- Concurrent serious diseases of liver, kidney, heart or other complications which, in the opinion of the investigator(s), 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
- Contra-indications (e.g., known or suspected allergy) to budesonide, fluticasone or lactose contained in the investigational product
- Participation in another clinical study within 12 weeks prior to the observation period or during the study
Show all 11Show fewer
- Previous enrolment in the present study
- Current use of budesonide turbuhaler
- Pregnancy or possible pregnancy, or planning to be pregnant during the study period
- Patients whose legal representative/caregiver is involved in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
- Other subjects who are considered inappropriate to participate in this study as judged by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Parallel-group, 6 Week Treatment, Multi-center, Phase III Study to Investigate the Efficacy and Safety of 100ug and 200ug Twice Daily of Budesonide Turbuhaler® and 50ug and 100umg Twice Daily of Fluticasone Diskus® in Japanese Children With Bronchial Asthma Aged 5-15
To investigate the effect and safety of budesonide Turbuhaler® 100 μg/dose and 200 μg/dose twice daily for 6 weeks in Japanese children with bronchial asthma aged 5 years to 15 years old in need for inhaled glucocorticosteroid treatment. To compare the efficacy of budesonide Turbuhaler® 100 μg/dose and 200 μg/dose twice daily for 6 weeks to that of fluticasone Diskus® 50 μg/dose and 100 μg/dose twice daily for 6 week.
- Conditions
- Asthma
- Being tested
- budesonide, fluticasone
- 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®
fluticasoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the effect of budesonide Turbuhaler® 100 μg/dose twice daily and 200 μg/dose twice daily for 6 weeks in Japanese children with bronchial asthma aged 5 years to 15 years old in need for inhaled glucocorticosteroid treatment
Measured: 6 weeks
Secondary outcomes (2)
To investigate the safety of budesonide Turbuhaler 100 μg/dose twice daily and 200 μg/dose twice daily for 6 weeks in Japanese children with bronchial asthma aged 5 years to 15 years old in need for inhaled glucocorticosteroid treatment
Measured: 6 weeks
To compare the efficacy of budesonide Turbuhaler 100 μg/dose twice daily and 200 μg/dose twice daily for 6 weeks to that of fluticasone Diskus® 50 μg/dose twice daily and 100 μg/dose twice daily for 6 weeks
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2007 (estimated)
- Study startOct 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 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
- NCT00504062
- Sponsor's protocol ID
- D5254C00769
- Status last verified
- Aug 2011
- First submitted
- 17 Jul 2007
- Last updated
- 24 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Parallel-group, 6 Week Treatment, Multi-center, Phase III Study to Investigate the Efficacy and Safety of 100ug and 200ug Twice Daily of Budesonide Turbuhaler® and 50ug and 100umg Twice Daily of Fluticasone Diskus® in Japanese Children With Bronchial Asthma Aged 5-15
- ClinicalTrials.gov ID
- NCT00504062
- Acronym / sponsor ID
- D5254C00769
- Conditions
- Asthma
- Keywords
- asthma, bronchial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Study completion
- Oct 2007 (actual)
- First posted
- 19 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effect and safety of budesonide Turbuhaler® 100 μg/dose and 200 μg/dose twice daily for 6 weeks in Japanese children with bronchial asthma aged 5 years to 15 years old in need for inhaled glucocorticosteroid treatment. To compare the efficacy of budesonide Turbuhaler® 100 μg/dose and 200 μg/dose twice daily for 6 weeks to that of fluticasone Diskus® 50 μg/dose and 100 μg/dose twice daily for 6 week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Provision of signed written informed consent by patient's legal representative; when possible a signed written informed consent should be obtained from the patient themselves
- Patients diagnosed as having bronchial asthma regardless of type of asthma i.e. perennial or seasonal, atopic or non-atopic
- Males/females 5-15 yrs old who are able to experience to inhale with turbuhaler and diskus. the investigator will check whether the patient can inhale appropriately using training devises and "Turbuhaler trainer"
- Patients with bronchial asthma who require treatment with inhaled steroids (patients with drug therapy, in whom asthma is poorly controlled)
- Patients who are already treated with inhaled GCS should have at least 3 months prehistory of asthma before obtaining the written informed consent
Key exclusion criteria (11 listed)
- Use of regular(more than 3 days) systemic (oral, intravenous or intramuscular) steroids within 30 days before the observation period
- The daily dose of inhaled GCS within 30 days before the observation period for the patients who are already treated with inhaled GCS is beyond fluticasone propionate (FP) 200 µg/day or beclomethasone dipropionate (BDP) 200 μg/day.
- 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 within 30 days before the observation period.
- Concurrent serious diseases of liver, kidney, heart or other complications which, in the opinion of the investigator(s), 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
- Contra-indications (e.g., known or suspected allergy) to budesonide, fluticasone or lactose contained in the investigational product
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® | Drug | – |
| fluticasone | Drug | – |
Primary outcome
To investigate the effect of budesonide Turbuhaler® 100 μg/dose twice daily and 200 μg/dose twice daily for 6 weeks in Japanese children with bronchial asthma aged 5 years to 15 years old in need for inhaled glucocorticosteroid treatment
Time frame: 6 weeks
2 secondary outcomes
To investigate the safety of budesonide Turbuhaler 100 μg/dose twice daily and 200 μg/dose twice daily for 6 weeks in Japanese children with bronchial asthma aged 5 years to 15 years old in need for inhaled glucocorticosteroid treatment
Time frame: 6 weeks
To compare the efficacy of budesonide Turbuhaler 100 μg/dose twice daily and 200 μg/dose twice daily for 6 weeks to that of fluticasone Diskus® 50 μg/dose twice daily and 100 μg/dose twice daily for 6 weeks
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2011.
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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 fluticasone 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 5 inclusion and 11 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 24 Aug 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To investigate the effect of budesonide Turbuhaler® 100 μg/dose twice daily and 200 μg/dose twice daily for 6 weeks in Japanese children with bronchial asthma aged 5 years to 15 years old in need for inhaled glucocorticosteroid treatment (time frame: 6 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 24 Aug 2011.