AsthmaPhase 3NCT00398151
To Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy (0476-366)
A Phase 3 study testing MK0476, montelukast sodium / Duration of Treatment: 12 Weeks in people with Asthma, run by Organon and Co.
Trial summary
To evaluate the changes in proinflammatory markers (ltd4 in urine) and eosinophil from peripheral blood after newly initiated montelukast therapy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- MK0476, montelukast sodium / Duration of Treatment: 12 Weeks
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2005to 18 Jan 2006
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Allergic rhinitis symptoms: sneezing, rhinorrhea, obstruction of the nasal passages, itchy nose and throat, and conjunctival
- Male or female outpatient 20 years of age and older
- Patients with the following signs and symptoms of asthma and allergic rhinitis: history of cough, wheezing, shortness of breath, positive methacholine bronchoprovocation test
Who cannot join
- Active, acute or chronic, pulmonary disorder (besides asthma) documented by history, physical examination, or chest x-ray. history of anaphylactic or hypersensitive to study drug
- Requires oral, intravenous, or intramuscular corticosteroids on daily routine basis
- Started on immunotherapy within six months before the pre-study visit and/or the dose of immunotherapy is expected to change over the course of the study
- Treated with montelukast within 3 months before enrollment
- Unable to perform acceptable, reproducible spirometry and peak flow measurement
- Unresolved symptoms and signs of an upper respiratory tract infection (uri) within 2 weeks prior to visit 1
About this study
Official title: An Open-Label Study to Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy
To evaluate the changes in proinflammatory markers (ltd4 in urine) and eosinophil from peripheral blood after newly initiated montelukast therapy.
- Conditions
- Asthma
- Being tested
- MK0476, montelukast sodium / Duration of Treatment: 12 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, montelukast sodium / Duration of Treatment: 12 WeeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Ltd4 in urine and eosinophil from peripheral blood over 3 months of therapy
Secondary outcomes (1)
Asthma symptoms score throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2006 (estimated)
- Study start1 Aug 2005
- Primary completion18 Jan 2006
- Study completion18 Jan 2006
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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 58 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
- NCT00398151
- Sponsor's protocol ID
- 0476-366
- Other IDs
- 2006_043
- Status last verified
- Jan 2022
- First submitted
- 9 Nov 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
- An Open-Label Study to Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy
- ClinicalTrials.gov ID
- NCT00398151
- Acronym / sponsor ID
- 0476-366
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2005 (actual)
- Primary completion
- 18 Jan 2006 (actual)
- Study completion
- 18 Jan 2006 (actual)
- First posted
- 10 Nov 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.
To evaluate the changes in proinflammatory markers (ltd4 in urine) and eosinophil from peripheral blood after newly initiated montelukast therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Allergic rhinitis symptoms: sneezing, rhinorrhea, obstruction of the nasal passages, itchy nose and throat, and conjunctival
- Male or female outpatient 20 years of age and older
- Patients with the following signs and symptoms of asthma and allergic rhinitis: history of cough, wheezing, shortness of breath, positive methacholine bronchoprovocation test
Key exclusion criteria (6 listed)
- Active, acute or chronic, pulmonary disorder (besides asthma) documented by history, physical examination, or chest x-ray. history of anaphylactic or hypersensitive to study drug
- Requires oral, intravenous, or intramuscular corticosteroids on daily routine basis
- Started on immunotherapy within six months before the pre-study visit and/or the dose of immunotherapy is expected to change over the course of the study
- Treated with montelukast within 3 months before enrollment
- Unable to perform acceptable, reproducible spirometry and peak flow measurement
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: 12 Weeks | Drug | – |
Primary outcome
Ltd4 in urine and eosinophil from peripheral blood over 3 months of therapy
1 secondary outcome
Asthma symptoms score throughout the study
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 3 study testing MK0476, montelukast sodium / Duration of Treatment: 12 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 3 inclusion and 6 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?
Ltd4 in urine and eosinophil from peripheral blood over 3 months of therapy. 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.