AsthmaPhase 4NCT00380705
Quality of Life in Asthma and Rhinitis Allergic With Singulair (0476-365)
A Phase 4 study testing MK0476, Singulair, montelukast sodium / Duration of Treatment: 8 Weeks in people with Asthma and Rhinitis Allergic, run by Organon and Co.
Trial summary
Allow physicians not familiar with anti-leukotriene based therapy to test it Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Asthma, Rhinitis Allergic
- What is being tested?
- MK0476, Singulair, montelukast sodium / Duration of Treatment: 8 Weeks
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- 18 Mar 2005to 29 Jul 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Establish diagnosis of mild to moderate chronic asthma and/or allergic rhinitis currently on treatment
- Voluntary acceptance to participate in the study
Who cannot join
- Patients with cystic fibrosis
- Patients with known hypersensitivity to singulair or any of its components
- Patients with severe chronic asthma
About this study
Official title: Quality of Life in Asthma and Rhinitis Allergic With Singulair
Allow physicians not familiar with anti-leukotriene based therapy to test it
- Conditions
- Asthma, Rhinitis Allergic
- Being tested
- MK0476, Singulair, montelukast sodium / Duration of Treatment: 8 Weeks
- Medical subject headings
- Asthma, Rhinitis, Allergic, Perennial
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: 8 WeeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life measures
Secondary outcomes (1)
Nocturnal wake up, work or school absences, physical activity and recurrence of asthma and/or rhinitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2006 (estimated)
- Study start18 Mar 2005
- Primary completion29 Jul 2005
- Study completion29 Jul 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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (estimated)
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
- NCT00380705
- Sponsor's protocol ID
- 0476-365
- Other IDs
- 2006_033
- Status last verified
- Jan 2022
- First submitted
- 22 Sep 2006
- 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
- Quality of Life in Asthma and Rhinitis Allergic With Singulair
- ClinicalTrials.gov ID
- NCT00380705
- Acronym / sponsor ID
- 0476-365
- Conditions
- Asthma, Rhinitis Allergic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2005 (actual)
- Primary completion
- 29 Jul 2005 (actual)
- Study completion
- 29 Jul 2005 (actual)
- First posted
- 26 Sep 2006 (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.
Allow physicians not familiar with anti-leukotriene based therapy to test it
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Establish diagnosis of mild to moderate chronic asthma and/or allergic rhinitis currently on treatment
- Voluntary acceptance to participate in the study
Key exclusion criteria (3 listed)
- Patients with cystic fibrosis
- Patients with known hypersensitivity to singulair or any of its components
- Patients with severe chronic 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, Singulair, montelukast sodium / Duration of Treatment: 8 Weeks | Drug | – |
Primary outcome
Quality of life measures
1 secondary outcome
Nocturnal wake up, work or school absences, physical activity and recurrence of asthma and/or rhinitis
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: 8 Weeks in people with Asthma and Rhinitis Allergic, 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 2 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?
Quality of life measures. 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.