Asthma, BronchialPhase 3NCT00489346
A Study to Evaluate MK0476 and Fluticasone to Control Asthma in Patients With Mild Persistent Asthma (0476-910)
A Phase 3 study testing MK0476, montelukast sodium / Duration of Treatment: 1 Year and Comparator : fluticasone propionate / Duration of Treatment: 1 Year in people with Asthma, Bronchial, run by Organon and Co.
Trial summary
A study to evaluate MK0476 and Fluticasone to control asthma in patients with mild persistent asthma. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Asthma, Bronchial
- What is being tested?
- MK0476, montelukast sodium / Duration of Treatment: 1 Year and Comparator : fluticasone propionate / Duration of Treatment: 1 Year
- How many people
- 994 participants
- Where
- No sites listed yet
- Study dates
- Oct 2001to Jun 2002
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient is male or female, 6-14 years of age with mild persistent asthma
- Patient has a history of the following symptoms: wheezing, chest tightness, cough, etc.
- Patient has asthma diagnosed by a doctor
Who cannot join
- Patient is hospitalized
- Patient has had major surgery or participated in another clinical trial in the last 4 weeks
- Patient has been on a breathing tube for asthma
About this study
Official title: A Double-Blind, Randomized, Double-Dummy, Multicenter Study to Evaluate and Compare Oral Montelukast and Inhaled Fluticasone in the Control of Asthma for 6- to 14-Year-Olds With Mild Persistent Asthma
A study to evaluate MK0476 and Fluticasone to control asthma in patients with mild persistent asthma.
- Conditions
- Asthma, Bronchial
- Being tested
- MK0476, montelukast sodium / Duration of Treatment: 1 Year, Comparator : fluticasone propionate / Duration of Treatment: 1 Year
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0476, montelukast sodium / Duration of Treatment: 1 YearDrug
Comparator : fluticasone propionate / Duration of Treatment: 1 YearDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of asthma with MK0476 and Fluticasone as measured by number of asthma rescue-free days
Measured: Duration of Trial
Secondary outcomes (1)
Improved effect of MK0476 and fluticasone on FEV1 values
Measured: Duration of Trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startOct 2001
- Primary completionJun 2002
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma, BronchialStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 994 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489346
- Sponsor's protocol ID
- 0476-910
- Other IDs
- 2007_574
- Status last verified
- Feb 2022
- First submitted
- 20 Jun 2007
- Last updated
- 15 Aug 2024
- Results posted
- No
Publications
Garcia Garcia ML, Wahn U, Gilles L, Swern A, Tozzi CA, Polos P. Montelukast, compared with fluticasone, for control of asthma among 6- to 14-year-old patients with mild asthma: the MOSAIC study. Pediatrics. 2005 Aug;116(2):360-9. doi: 10.1542/peds.2004-1172.
PubMed 16061590
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Double-Dummy, Multicenter Study to Evaluate and Compare Oral Montelukast and Inhaled Fluticasone in the Control of Asthma for 6- to 14-Year-Olds With Mild Persistent Asthma
- ClinicalTrials.gov ID
- NCT00489346
- Acronym / sponsor ID
- 0476-910
- Conditions
- Asthma, Bronchial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 994 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Oct 2001
- Primary completion
- Jun 2002 (actual)
- Study completion
- Jun 2002 (actual)
- First posted
- 21 Jun 2007 (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 study to evaluate MK0476 and Fluticasone to control asthma in patients with mild persistent asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patient is male or female, 6-14 years of age with mild persistent asthma
- Patient has a history of the following symptoms: wheezing, chest tightness, cough, etc.
- Patient has asthma diagnosed by a doctor
Key exclusion criteria (3 listed)
- Patient is hospitalized
- Patient has had major surgery or participated in another clinical trial in the last 4 weeks
- Patient has been on a breathing tube for asthma
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 |
|---|---|---|
| MK0476, montelukast sodium / Duration of Treatment: 1 Year | Drug | – |
| Comparator : fluticasone propionate / Duration of Treatment: 1 Year | Drug | – |
Primary outcome
Improvement of asthma with MK0476 and Fluticasone as measured by number of asthma rescue-free days
Time frame: Duration of Trial
1 secondary outcome
Improved effect of MK0476 and fluticasone on FEV1 values
Time frame: Duration of Trial
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 15 Aug 2024.
- Background: PubMed 16061590Garcia Garcia ML, Wahn U, Gilles L, Swern A, Tozzi CA, Polos P. Montelukast, compared with fluticasone, for control of asthma among 6- to 14-year-old patients with mild asthma: the MOSAIC study. Pediatrics. 2005 Aug;116(2):360-9. doi: 10.1542/peds.2004-1172.
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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 Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MK0476, montelukast sodium / Duration of Treatment: 1 Year and Comparator : fluticasone propionate / Duration of Treatment: 1 Year in people with Asthma, Bronchial, run by Organon and Co.
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 15 Aug 2024. 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?
Improvement of asthma with MK0476 and Fluticasone as measured by number of asthma rescue-free days (time frame: Duration of Trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00489346, which also lists 1 linked publication.
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 15 Aug 2024.