AsthmaPhase 3NCT00642161
New Version Pulmicort Turbuhaler USA Children
A Phase 3 study testing budesonide in people with Asthma, run by AstraZeneca.
Trial summary
A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in children and adolescents who have asthma. In addition the study evaluated the functionality of the new inhaler at the end of its intended life. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- budesonide
- How many people
- 430 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Sep 2004
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or females aged 6 to 17 with a diagnosis of asthma for at least 3 months. Have used inhaled corticosteroids for no more than one month before entering the study or none at all.
- A forced expiratory volume (FEV1) in 1 second of 75% to 90% of predicted normal for those aged 6 to 11 and 60% to 90% for those aged 12 to 17 years.
- Airway reversibility of at least 12% , use of orally inhaled corticosteroids for no more than one month immediately before entering the study or none at all.
Who cannot join
- Life threatening asthma, Two or more overnight hospitalisations for asthma within 1 year or any emergency room visit for asthma within 6 months of starting study.
- Use of steroid tablets or injections during the month prior to Visit 1 and use of other asthma medicines (except rescue medication) within 2 weeks prior to the study.
- Any acute exacerbation of asthma or a respiratory tract infection within 30 days prior to Visit 1. Must not smoke or have smoked.
About this study
Official title: A Placebo-controlled Comparison of the Efficacy, Safety and Pharmacokinetics of the Current US Version of Pulmicort (Budesonide) Turbuhaler and the New Version of Pulmicort Turbuhaler in Asthmatic Children and Adolescents.
A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in children and adolescents who have asthma. In addition the study evaluated the functionality of the new inhaler at the end of its intended life.
- Conditions
- Asthma
- Being tested
- budesonide
- Keywords
- Asthma, Pulmicort, Children, Paediatrics, budesonide, Flexhaler
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in % predicted Forced Expiratory Volume in 1 second
Measured: Week 2, 4 and 8, then at week 12
Secondary outcomes (3)
Change from baseline in Forced Vital Capacity, Morning Peak Expiratory Flow, Daytime and nighttime asthma symptom scores, beta-agonist use and discontinuation rate
Measured: Week 2, 4 and 8, then at week 12
Incidence of Adverse Events
Measured: Week 2, 4 and 8, then at week 12
Pharmacokinetics of budesonide (AUC, maximum concentration and time to maximum concentration
Measured: 6 or 12 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startNov 2002
- Primary completionSep 2004
- Study completionSep 2004
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
- Double blind
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bertil Andersson, Study director, AstraZeneca employeeLars-Göran Carlsson, Study director, AstraZeneca employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00642161
- Sponsor's protocol ID
- SD-004-0726
- Other IDs
- D5254C00726
- Status last verified
- Jan 2011
- First submitted
- 18 Mar 2008
- Last updated
- 24 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo-controlled Comparison of the Efficacy, Safety and Pharmacokinetics of the Current US Version of Pulmicort (Budesonide) Turbuhaler and the New Version of Pulmicort Turbuhaler in Asthmatic Children and Adolescents.
- ClinicalTrials.gov ID
- NCT00642161
- Acronym / sponsor ID
- SD-004-0726
- Conditions
- Asthma
- Keywords
- Asthma, Pulmicort, Children, Paediatrics, budesonide, Flexhaler
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 24 Mar 2008 (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.
A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in children and adolescents who have asthma. In addition the study evaluated the functionality of the new inhaler at the end of its intended life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male or females aged 6 to 17 with a diagnosis of asthma for at least 3 months. Have used inhaled corticosteroids for no more than one month before entering the study or none at all.
- A forced expiratory volume (FEV1) in 1 second of 75% to 90% of predicted normal for those aged 6 to 11 and 60% to 90% for those aged 12 to 17 years.
- Airway reversibility of at least 12% , use of orally inhaled corticosteroids for no more than one month immediately before entering the study or none at all.
Key exclusion criteria (3 listed)
- Life threatening asthma, Two or more overnight hospitalisations for asthma within 1 year or any emergency room visit for asthma within 6 months of starting study.
- Use of steroid tablets or injections during the month prior to Visit 1 and use of other asthma medicines (except rescue medication) within 2 weeks prior to the study.
- Any acute exacerbation of asthma or a respiratory tract infection within 30 days prior to Visit 1. Must not smoke or have smoked.
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 | Drug | – |
Primary outcome
Change from Baseline in % predicted Forced Expiratory Volume in 1 second
Time frame: Week 2, 4 and 8, then at week 12
3 secondary outcomes
Change from baseline in Forced Vital Capacity, Morning Peak Expiratory Flow, Daytime and nighttime asthma symptom scores, beta-agonist use and discontinuation rate
Time frame: Week 2, 4 and 8, then at week 12
Incidence of Adverse Events
Time frame: Week 2, 4 and 8, then at week 12
Pharmacokinetics of budesonide (AUC, maximum concentration and time to maximum concentration
Time frame: 6 or 12 hours post dose
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 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.
Bertil Andersson study director
AstraZeneca employee
Lars-Göran Carlsson study director
AstraZeneca employee
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing budesonide in people with 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 3 inclusion and 3 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 2011. 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.
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?
Change from Baseline in % predicted Forced Expiratory Volume in 1 second (time frame: Week 2, 4 and 8, then at week 12). 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 2011.