AsthmaPhase 3NCT00697697
A Study of 2 Doses of MAP0010 in Asthmatic Children
A Phase 3 study testing 0.135mg MAP0010 and 0.25mg MAP0010 in people with Asthma, run by Allergan.
Trial summary
The purpose of this study is to examine the safety of two doses of MAP0010 in asthmatic children, 12 months to 8 years of age, over a 40-week period. Read more about this study
- Who is it for?
- Ages 12 months to 8 years
- Conditions the study is for
- Asthma
- What is being tested?
- 0.135mg MAP0010 and 0.25mg MAP0010
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- Apr 2008to Dec 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 months to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Completed 12 weeks of treatment in the MAP0010-CL-P301 study.
- Patient, parent, and guardian (as appropriate) are willing for child to undergo all study procedures and willing to sign the informed consent and assent, as appropriate.
Who cannot join
- Less than 80% compliance with either study treatment and/or other study procedures (e.g., completion of symptom e-diary) in the MAP0010-CL-P301 Study.
About this study
Official title: A Randomized, Double-blind, Active-controlled, Phase 3 Extension Study Investigating the Safety and Efficacy Over 40 Weeks of 2 Doses of MAP0010 in Asthmatic Children (12 Months to 8 Years Old at the Time of Enrollment Into the MAP0010-CL-P301 Study)
The purpose of this study is to examine the safety of two doses of MAP0010 in asthmatic children, 12 months to 8 years of age, over a 40-week period.
- Conditions
- Asthma
- Being tested
- 0.135mg MAP0010, 0.25mg MAP0010
- Keywords
- asthmatic children
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.135mg MAP0010Drug
0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
0.25mg MAP0010Drug
0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
| Study group | Role | What they receive |
|---|---|---|
| 0.135mg MAP0010 | Experimental | 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks Receives: Drug: 0.135mg MAP0010 |
| 0.25mg MAP0010 | Experimental | 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks Receives: Drug: 0.25mg MAP0010 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Treatment Emergent Adverse Events Related to Study Drug
A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.
Measured: 40 weeks
Number of Patients Reporting at Least One Treatment Emergent Adverse Event Leading to Study Termination
A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.
Measured: 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2009
- Study completionDec 2009
Why it stopped: Corporate decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, MAP Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697697
- Sponsor's protocol ID
- MAP0010-CL-P301X
- Status last verified
- Dec 2013
- First submitted
- 12 Jun 2008
- Last updated
- 9 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active-controlled, Phase 3 Extension Study Investigating the Safety and Efficacy Over 40 Weeks of 2 Doses of MAP0010 in Asthmatic Children (12 Months to 8 Years Old at the Time of Enrollment Into the MAP0010-CL-P301 Study)
- ClinicalTrials.gov ID
- NCT00697697
- Acronym / sponsor ID
- MAP0010-CL-P301X
- Conditions
- Asthma
- Keywords
- asthmatic children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Corporate decision
- Enrolment
- 192 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Collaborators
- MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
- Study start
- Apr 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 Jun 2008 (estimated)
- Results
- Posted 23 Oct 2013
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 examine the safety of two doses of MAP0010 in asthmatic children, 12 months to 8 years of age, over a 40-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.135mg MAP0010 | Experimental | Drug: 0.135mg MAP00100.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks |
| 0.25mg MAP0010 | Experimental | Drug: 0.25mg MAP00100.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks |
Who may qualify
- Ages
- 12 months to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Completed 12 weeks of treatment in the MAP0010-CL-P301 study.
- Patient, parent, and guardian (as appropriate) are willing for child to undergo all study procedures and willing to sign the informed consent and assent, as appropriate.
Key exclusion criteria (1 listed)
- Less than 80% compliance with either study treatment and/or other study procedures (e.g., completion of symptom e-diary) in the MAP0010-CL-P301 Study.
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 |
|---|---|---|
| 0.135mg MAP00100.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks | Drug | 0.135mg MAP0010 |
| 0.25mg MAP00100.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks | Drug | 0.25mg MAP0010 |
Primary outcome
Number of Patients With Treatment Emergent Adverse Events Related to Study Drug
Time frame: 40 weeks
A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.
Number of Patients Reporting at Least One Treatment Emergent Adverse Event Leading to Study Termination
Time frame: 40 weeks
A treatment emergent adverse event is one with a start date on or after the date of first administration of the study drug during the study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director study director
MAP Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.135mg MAP0010 and 0.25mg MAP0010 in people with Asthma, run by Allergan.
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 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: stopped early, as of the sponsor's last update on 9 Jan 2014. 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?
Yes. Results are posted in the registry (first posted 23 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Treatment Emergent Adverse Events Related to Study Drug (time frame: 40 weeks). 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 9 Jan 2014.