Bronchial AsthmaPEACE-PedsNCT01203904
Pulmicort Turbuhaler 100/200 Specific Clinical Experience Investigation
An observational study of Bronchial Asthma, run by AstraZeneca at 37 sites in Japan.
Trial summary
The purpose of this study is to confirm the safety profile for long term treatment in children aged 5 years and <15 years on bronchial asthma in daily clinical usage/Effect on growth rate. Effect on adrenal function. Development of infection diseases by diseases type. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bronchial Asthma
- How many people
- 301 participants
- Where
- 37 sitesJapan
- Study dates
- Sep 2010to Sep 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients treated with Pulmicort Turbuhaler for the firtst time due to bronchial asthma and children of >= 5 years and < 15 years old age at the start of study treatment
Who may be able to join
- Patients treated with Pulmicort Turbuhaler for the first time due to bronchial asthma and children of >= 5 years and < 15 years old age at the start of study treatment
Who cannot join
None listed.
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
Japan37 sites
Research Site
Aichi
Research Site
Chiba
Research Site
Ehime
Research Site
Fukui
Research Site
Fukuoka
Research Site
Fukushima
Research Site
Gifu
Research Site
Gunma
Research Site
Hiroshima
Research Site
Hokkaido
Research Site
Hyōgo
Research Site
Ibaraki
Research Site
Kagawa
Research Site
Kagoshima
Research Site
Kanagawa
Research Site
Kochi
Research Site
Kyoto
Research Site
Mie
Research Site
Miyagi
Research Site
Nagano
Research Site
Niigata
Research Site
Numakunai
Research Site
Ōita
Research Site
Okayama
Research Site
Osaka
Research Site
Saga
Research Site
Saitama
Research Site
Shiga
Research Site
Shimane
Research Site
Shizuoka
Research Site
Tochigi
Research Site
Tokushima
Research Site
Tokyo
Research Site
Tottori
Research Site
Toyama
Research Site
Yamagata
Research Site
Yamaguchi
About this study
Official title: Pulmicort Turbuhaler 100/200 Specific Clinical Experience Investigation for Long Term Use in Pediatrics
The purpose of this study is to confirm the safety profile for long term treatment in children aged 5 years and <15 years on bronchial asthma in daily clinical usage/Effect on growth rate. Effect on adrenal function. Development of infection diseases by diseases type.
- Conditions
- Bronchial Asthma
- Keywords
- bronchial asthma, Pulmicort, long term use, pediatrics
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pulmicort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event incidence. We will investigate, intensively, development of Adverse Drug Reactions, especially infections. Detection of Adverse Drug Reactions unexpected from the Precautions for use.
Measured: Two years
Effects on growth rate and the adrenal cortical function, development of infections
Measured: Two years
Secondary outcomes (2)
Variation of the asthma control status (total of JPAC：Japanese Pediatric Asthma Control Program score) from the baseline score.
Measured: Two years
Variation of the parental questionnaire (score by factor) from the baseline score.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shigeru Yoshida, Study director, AstraZenecaKK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203904
- Sponsor's protocol ID
- D525AL00001
- Acronym
- PEACE-Peds
- Status last verified
- Jun 2016
- First submitted
- 6 Sep 2010
- Last updated
- 7 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmicort Turbuhaler 100/200 Specific Clinical Experience Investigation for Long Term Use in Pediatrics
- ClinicalTrials.gov ID
- NCT01203904
- Acronym / sponsor ID
- PEACE-Peds / D525AL00001
- Conditions
- Bronchial Asthma
- Keywords
- bronchial asthma, Pulmicort, long term use, pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 17 Sep 2010 (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.
The purpose of this study is to confirm the safety profile for long term treatment in children aged 5 years and <15 years on bronchial asthma in daily clinical usage/Effect on growth rate. Effect on adrenal function. Development of infection diseases by diseases type.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmicort | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients treated with Pulmicort Turbuhaler for the firtst time due to bronchial asthma and children of >= 5 years and < 15 years old age at the start of study treatment
Key inclusion criteria (1 listed)
- Patients treated with Pulmicort Turbuhaler for the first time due to bronchial asthma and children of >= 5 years and < 15 years old age at the start of study treatment
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adverse event incidence. We will investigate, intensively, development of Adverse Drug Reactions, especially infections. Detection of Adverse Drug Reactions unexpected from the Precautions for use.
Time frame: Two years
Effects on growth rate and the adrenal cortical function, development of infections
Time frame: Two years
2 secondary outcomes
Variation of the asthma control status (total of JPAC：Japanese Pediatric Asthma Control Program score) from the baseline score.
Time frame: Two years
Variation of the parental questionnaire (score by factor) from the baseline score.
Time frame: Two years
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 7 Jun 2016.
- CSR SynopsisLink provided by the sponsor.
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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.
Shigeru Yoshida study director
AstraZenecaKK
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Asthma, run by AstraZeneca at 37 sites 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 1 inclusion and 0 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 7 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites 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.
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?
Adverse event incidence. We will investigate, intensively, development of Adverse Drug Reactions, especially infections. Detection of Adverse Drug Reactions unexpected from the Precautions for use. (time frame: Two years). The study lists 2 primary outcomes in all. 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 7 Jun 2016.