Bronchial AsthmaNCT01232322
Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation
An observational study of Bronchial Asthma, run by AstraZeneca.
Trial summary
The purpose of this study is to investigate the safety and efficacy for long term treatment of the drug in children aged 6 months and < 5 years on bronchial asthma in daily clinical usage. Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Bronchial Asthma
- How many people
- 633 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Jul 2011
- 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 6 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients treated with Pulmicort respules for the first time due to bronchial asthma and children of >=6months and <5 years old age at the start of study treatment
Who may be able to join
- Patients treated with Pulmicort Respules for the first time due to bronchial asthma
- Children of >= 6 months and < 5 years old age at the start of study treatment
Who cannot join
None listed.
About this study
Official title: Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation for Long-term Use in Pediatrics
The purpose of this study is to investigate the safety and efficacy for long term treatment of the drug in children aged 6 months and < 5 years on bronchial asthma in daily clinical usage.
- Conditions
- Bronchial Asthma
- Keywords
- bronchial asthma, Pulmicort Respules, 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 Respules | Those with an exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Measured: Range of 3 years
Effects on growth rate
Variation of the height/weight from the baseline.
Measured: Range of 3 years
Effects on the adrenal cortical function.
Symptoms of adrenal cortical function suppression before and after the treatment with Pulmicort.
Measured: Range of 3 years
Effects on development of infections.
Existence and type of infections.
Measured: Range of 3 years
Secondary outcomes (1)
Clinical course under Pulmicort long-term use
Validation of the frequency of asthmatic attack, level of the asthmatic attack, daily life, night sleep from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startOct 2006
- Primary completionJul 2011
- Study completionJul 2011
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
- 633 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoshida Shigeru, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232322
- Sponsor's protocol ID
- D5257L00014
- Status last verified
- Jan 2013
- First submitted
- 31 Oct 2010
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmicort Respules 0.25/0.5 Specific Clinical Experience Investigation for Long-term Use in Pediatrics
- ClinicalTrials.gov ID
- NCT01232322
- Acronym / sponsor ID
- D5257L00014
- Conditions
- Bronchial Asthma
- Keywords
- bronchial asthma, Pulmicort Respules, long term use, pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 633 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 2 Nov 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 investigate the safety and efficacy for long term treatment of the drug in children aged 6 months and < 5 years on bronchial asthma in daily clinical usage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmicort Respules | – | –Those with an exposure |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients treated with Pulmicort respules for the first time due to bronchial asthma and children of >=6months and <5 years old age at the start of study treatment
Key inclusion criteria (2 listed)
- Patients treated with Pulmicort Respules for the first time due to bronchial asthma
- Children of >= 6 months and < 5 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
Incidence of Adverse Events
Time frame: Range of 3 years
Effects on growth rate
Time frame: Range of 3 years
Variation of the height/weight from the baseline.
Effects on the adrenal cortical function.
Time frame: Range of 3 years
Symptoms of adrenal cortical function suppression before and after the treatment with Pulmicort.
Effects on development of infections.
Time frame: Range of 3 years
Existence and type of infections.
1 secondary outcome
Clinical course under Pulmicort long-term use
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 Jan 2013.
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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.
Yoshida Shigeru, MD study director
AstraZeneca
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Asthma, run by AstraZeneca.
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 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 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of Adverse Events (time frame: Range of 3 years). The study lists 4 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 24 Jan 2013.