AsthmaPhase 4FIRSTNCT00545324
First Step With Singulair® Therapy (0476-323)
A Phase 4 study testing MK0476 (singulair), montelukast sodium / Duration of Treatment: 6 Weeks and Comparator: Fluticasone / Duration of Treatment: 6 Weeks in people with Asthma, run by Organon and Co.
Trial summary
In adult patients with mild persistent asthma, singulair® 10 mg will be at least as effective as low dose Inhaled Corticosteroids (ICS) in improving asthma symptom control or satisfaction over a 6 week comparison period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- MK0476 (singulair), montelukast sodium / Duration of Treatment: 6 Weeks and Comparator: Fluticasone / Duration of Treatment: 6 Weeks
- How many people
- 399 participants
- Where
- No sites listed yet
- Study dates
- Sep 2002to Dec 2003
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First time diagnosis of mild asthma symptoms which requires an antiinflammatory controller medication
- Patients not controlled with short acting beta2 agonist (sab) therapy (requiring more than one treatment per week but less than 7 per week)
- Patients dissatisfied with low dose ics therapy, or patients reluctant to take ics therapy, or patients insufficiently controlled due to non-compliance with low dose ics therapy through out the preceding 6 weeks
- Patient's forced expiratory volume in one second (fev1) is < 80% of predicted value
Who cannot join
- Patient on combination therapy
- Patient on long acting beta2 agonists
- Patient on using moderate to high doses of ICS. (ICS >250 \µ g/day flovent\® or equivalent per day)
About this study
Official title: A 12 Week Multicenter, Open-Label, Randomized, Observational Study Comparing Singulair® 10 Mg As Controller Monotherapy In Adults With Mild Asthma "To Low Dose" Inhaled Corticosteroid Treatment
In adult patients with mild persistent asthma, singulair® 10 mg will be at least as effective as low dose Inhaled Corticosteroids (ICS) in improving asthma symptom control or satisfaction over a 6 week comparison period.
- Conditions
- Asthma
- Being tested
- MK0476 (singulair), montelukast sodium / Duration of Treatment: 6 Weeks, Comparator: Fluticasone / Duration of Treatment: 6 Weeks
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0476 (singulair), montelukast sodium / Duration of Treatment: 6 WeeksDrug
Comparator: Fluticasone / Duration of Treatment: 6 WeeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian asthma guidelines criteria
Secondary outcomes (1)
Asthma control questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startSep 2002
- Primary completionDec 2003
- Study completionDec 2003
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.
- 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
- 399 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
- NCT00545324
- Sponsor's protocol ID
- 0476-323
- Other IDs
- 2007_025
- Acronym
- FIRST
- Status last verified
- Jan 2022
- First submitted
- 16 Oct 2007
- Last updated
- 15 Aug 2024
- Results posted
- No
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 12 Week Multicenter, Open-Label, Randomized, Observational Study Comparing Singulair® 10 Mg As Controller Monotherapy In Adults With Mild Asthma "To Low Dose" Inhaled Corticosteroid Treatment
- ClinicalTrials.gov ID
- NCT00545324
- Acronym / sponsor ID
- FIRST / 0476-323
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Sep 2002
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 17 Oct 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.
In adult patients with mild persistent asthma, singulair® 10 mg will be at least as effective as low dose Inhaled Corticosteroids (ICS) in improving asthma symptom control or satisfaction over a 6 week comparison period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First time diagnosis of mild asthma symptoms which requires an antiinflammatory controller medication
- Patients not controlled with short acting beta2 agonist (sab) therapy (requiring more than one treatment per week but less than 7 per week)
- Patients dissatisfied with low dose ics therapy, or patients reluctant to take ics therapy, or patients insufficiently controlled due to non-compliance with low dose ics therapy through out the preceding 6 weeks
- Patient's forced expiratory volume in one second (fev1) is < 80% of predicted value
Key exclusion criteria (3 listed)
- Patient on combination therapy
- Patient on long acting beta2 agonists
- Patient on using moderate to high doses of ICS. (ICS >250 \µ g/day flovent\® or equivalent per day)
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 (singulair), montelukast sodium / Duration of Treatment: 6 Weeks | Drug | – |
| Comparator: Fluticasone / Duration of Treatment: 6 Weeks | Drug | – |
Primary outcome
Canadian asthma guidelines criteria
1 secondary outcome
Asthma control questionnaire
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.
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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 4 study testing MK0476 (singulair), montelukast sodium / Duration of Treatment: 6 Weeks and Comparator: Fluticasone / Duration of Treatment: 6 Weeks in people with Asthma, 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 4 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 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?
Canadian asthma guidelines criteria. 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 15 Aug 2024; AzTrials last refreshed its copy on 30 Oct 2026.