AsthmaPhase 4NCT00641472
Pulmicort Respules(Budesonide Inhalation Suspension) vs Singulair, Children
A Phase 4 study testing Budesonide inhalation suspension and Montelukast Sodium in people with Asthma, run by AstraZeneca.
Trial summary
A one year study comparing the safety and effectiveness of Pulmicort (0.5mg strength given once a day in the evening) with either 4 or 5mg strength SINGULAR (given once a day in the evening) in children with asthma aged 2 to 8. Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide inhalation suspension and Montelukast Sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- No sites listed yet
- Study dates
- Oct 2002to Feb 2005
- Phase
- Phase 4
- 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 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 2 to 8 at study entry
- At least 3 episodes of wheezing in the previous year that lasted more than 24 hours and affected sleep or symptoms of mild persistent asthma
- use of b-2 agonist treatment on at least 3 of 7 consecutive days or run in
Who cannot join
- Severe or unstable asthma
- any significant finding at a physical exam
- an exacerbation of asthma in the 30 days before entering the study that might affect study results in judgement of the study doctor
About this study
Official title: An Evaluation of the Effectiveness of Pulmicort Respules (Budesonide Inhalation Suspension) Versus SINGULAIR (Montelukast Sodium) in Children 2-8 Years Old With Asthma Requiring Controller Therapy.
A one year study comparing the safety and effectiveness of Pulmicort (0.5mg strength given once a day in the evening) with either 4 or 5mg strength SINGULAR (given once a day in the evening) in children with asthma aged 2 to 8. If allocated to SINGULAR treatment, children aged between 2 and 5 will receive 4mg strength SINGULAR and those aged between 6 and 8 will receive 5mg strength SINGULAR.
- Conditions
- Asthma
- Being tested
- Budesonide inhalation suspension, Montelukast Sodium
- Keywords
- Asthma, Pulmicort, Children, paediatrics, budesonide
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide inhalation suspensionDrug
Also called Pulmicort Respules
0.5mg
Montelukast SodiumDrug
Also called SINGULAR
4mg or 5mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Budesonide inhalation suspension Receives: Drug: Budesonide inhalation suspension |
| 2 | Active comparator | Montelukast sodium Receives: Drug: Montelukast Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first asthma medication as either step-up PULMICORT RESPULES or oral steroids
Measured: Each clinic visit
Secondary outcomes (3)
Incidence and Severity of Adverse Events
Measured: Each clinic visit
Time to 1st additional asthma medication measured at 12 weeks and 26 weeks
Measured: Each clinic visit
Time to 1st acute severe exacerbation (as measured by the need for oral steroids), measured at 12 weeks, 26 weeks, and 52 weeks
Measured: Each clinic visit
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 startOct 2002
- Primary completionFeb 2005
- Study completionFeb 2005
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bertil Andersson, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641472
- Sponsor's protocol ID
- DX-RES-2103
- Other IDs
- D5257L00750
- Status last verified
- Mar 2009
- First submitted
- 18 Mar 2008
- Last updated
- 25 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Effectiveness of Pulmicort Respules (Budesonide Inhalation Suspension) Versus SINGULAIR (Montelukast Sodium) in Children 2-8 Years Old With Asthma Requiring Controller Therapy.
- ClinicalTrials.gov ID
- NCT00641472
- Acronym / sponsor ID
- DX-RES-2103
- Conditions
- Asthma
- Keywords
- Asthma, Pulmicort, Children, paediatrics, budesonide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2002
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (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 one year study comparing the safety and effectiveness of Pulmicort (0.5mg strength given once a day in the evening) with either 4 or 5mg strength SINGULAR (given once a day in the evening) in children with asthma aged 2 to 8. If allocated to SINGULAR treatment, children aged between 2 and 5 will receive 4mg strength SINGULAR and those aged between 6 and 8 will receive 5mg strength SINGULAR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Budesonide inhalation suspensionBudesonide inhalation suspension |
| 2 | Active comparator | Drug: Montelukast SodiumMontelukast sodium |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged 2 to 8 at study entry
- At least 3 episodes of wheezing in the previous year that lasted more than 24 hours and affected sleep or symptoms of mild persistent asthma
- use of b-2 agonist treatment on at least 3 of 7 consecutive days or run in
Key exclusion criteria (3 listed)
- Severe or unstable asthma
- any significant finding at a physical exam
- an exacerbation of asthma in the 30 days before entering the study that might affect study results in judgement of the study doctor
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 |
|---|---|---|
| Budesonide inhalation suspensionAlso: Pulmicort Respules0.5mg | Drug | 1 |
| Montelukast SodiumAlso: SINGULAR4mg or 5mg | Drug | 2 |
Primary outcome
Time to first asthma medication as either step-up PULMICORT RESPULES or oral steroids
Time frame: Each clinic visit
3 secondary outcomes
Incidence and Severity of Adverse Events
Time frame: Each clinic visit
Time to 1st additional asthma medication measured at 12 weeks and 26 weeks
Time frame: Each clinic visit
Time to 1st acute severe exacerbation (as measured by the need for oral steroids), measured at 12 weeks, 26 weeks, and 52 weeks
Time frame: Each clinic visit
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 25 Mar 2009.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
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.
Bertil Andersson study director
AstraZeneca
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Budesonide inhalation suspension and Montelukast Sodium 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 25 Mar 2009. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Time to first asthma medication as either step-up PULMICORT RESPULES or oral steroids (time frame: Each clinic visit). 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 25 Mar 2009.