AsthmaNCT00233584
Pulmicort Asthma Prevention (Post-PAC)
A study testing Pulmicort (budesonide) pMDI in people with Asthma, run by AstraZeneca at 1 site in Denmark.
Trial summary
This prospective study will evaluate the feasibility of the defined decision tree for the treatment of asthmatic young children. Children who develop episode (=3 consecutive days) of any troublesome lower respiratory symptoms are treated according to a strictly pre-defined multi-steps treatment algorithm until the age… Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Asthma
- What is being tested?
- Pulmicort (budesonide) pMDI
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2001to Jun 2006
- Phase
- Interventional
- 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 Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children form the COPSAC/PAC study with episodes of troublesome respiratory symptoms. Episodes are defined as 3 consecutive days of any troublesome lower respiratory symptoms.
Who cannot join
- Differential diagnoses including at least a chest x-ray and sweat test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Feasibility of a Treatment Algorithm in Newly Diagnosed Asthmatic Children. An Open Follow-up to Asthma Prevention in Infants/Young Children (PAC)
This prospective study will evaluate the feasibility of the defined decision tree for the treatment of asthmatic young children. Children who develop episode (=3 consecutive days) of any troublesome lower respiratory symptoms are treated according to a strictly pre-defined multi-steps treatment algorithm until the age of 6 years.
- Conditions
- Asthma
- Being tested
- Pulmicort (budesonide) pMDI
- Keywords
- Children of asthmatic mothers
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmicort (budesonide) pMDIProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of the treatment algorithm: Frequency of protocol deviations, asthma exacerbations, different treatment steps.
Efficacy - development of lung function.
Secondary outcomes (3)
Acceptability of the treatment algorithm by the parents.
Growth rate and BMD.
Exhaled nitrogen Oxide, bronchohyperresponsiveness.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2005 (estimated)
- Study startJul 2001
- Primary completionMay 2006
- Study completionJun 2006
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Denmark Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00233584
- Sponsor's protocol ID
- D5254C00004
- Status last verified
- Jan 2008
- First submitted
- 4 Oct 2005
- Last updated
- 14 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Feasibility of a Treatment Algorithm in Newly Diagnosed Asthmatic Children. An Open Follow-up to Asthma Prevention in Infants/Young Children (PAC)
- ClinicalTrials.gov ID
- NCT00233584
- Acronym / sponsor ID
- D5254C00004
- Conditions
- Asthma
- Keywords
- Children of asthmatic mothers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jul 2001
- Primary completion
- May 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 6 Oct 2005 (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.
This prospective study will evaluate the feasibility of the defined decision tree for the treatment of asthmatic young children. Children who develop episode (=3 consecutive days) of any troublesome lower respiratory symptoms are treated according to a strictly pre-defined multi-steps treatment algorithm until the age of 6 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children form the COPSAC/PAC study with episodes of troublesome respiratory symptoms. Episodes are defined as 3 consecutive days of any troublesome lower respiratory symptoms.
Key exclusion criteria (1 listed)
- Differential diagnoses including at least a chest x-ray and sweat test.
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 |
|---|---|---|
| Pulmicort (budesonide) pMDI | Procedure or surgery | – |
Primary outcome
Success rate of the treatment algorithm: Frequency of protocol deviations, asthma exacerbations, different treatment steps.
Efficacy - development of lung function.
3 secondary outcomes
Acceptability of the treatment algorithm by the parents.
Growth rate and BMD.
Exhaled nitrogen Oxide, bronchohyperresponsiveness.
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 14 Jan 2008.
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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.
AstraZeneca Denmark Medical Director, MD study director
AstraZeneca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmicort (budesonide) pMDI in people with Asthma, run by AstraZeneca at 1 site in Denmark.
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 1 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 14 Jan 2008. 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 Denmark. 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?
Success rate of the treatment algorithm: Frequency of protocol deviations, asthma exacerbations, different treatment steps.. 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 14 Jan 2008.