AsthmaPhase 4NCT00157937
A Study to Compare Effectiveness of Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics (0476-329)
A Phase 4 study testing MK0476; montelukast sodium/Duration of Treatment: 16 weeks and Comparator: theophylline ER/Duration of Treatment: 16 weeks in people with Asthma and Allergic Rhinitis, run by Organon and Co.
Trial summary
Subjects have 8-week with montelukast sodium or comparator drug administration period, 2-week wash-out period and 8-week comparator drug or the drug administration period (with cross-over design) for assessment of the drug efficacy, safety and tolerability. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma, Allergic Rhinitis
- What is being tested?
- MK0476; montelukast sodium/Duration of Treatment: 16 weeks and Comparator: theophylline ER/Duration of Treatment: 16 weeks
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Feb 2003to Jun 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males or females between the ages of 18 and 60 with mild to moderate asthma
Who cannot join
None listed.
About this study
Official title: A Randomized, Open Label, Cross-Over Study Comparing Effectiveness for the Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics
Subjects have 8-week with montelukast sodium or comparator drug administration period, 2-week wash-out period and 8-week comparator drug or the drug administration period (with cross-over design) for assessment of the drug efficacy, safety and tolerability.
- Conditions
- Asthma, Allergic Rhinitis
- Being tested
- MK0476; montelukast sodium/Duration of Treatment: 16 weeks, Comparator: theophylline ER/Duration of Treatment: 16 weeks
- Medical subject headings
- Asthma, Rhinitis, Allergic
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: 16 weeksDrug
Comparator: theophylline ER/Duration of Treatment: 16 weeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
Secondary outcomes (1)
AM-PEFR; daytime symptom score; treatment frequency of beta agonist; global assessment investigator's symptom assessment; Quality of Life Questionnaire for Adult Korean Asthmatics; QLQAKA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startFeb 2003
- Primary completionJun 2005
- Study completionJun 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 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
- NCT00157937
- Sponsor's protocol ID
- 0476-329
- Other IDs
- 2005_069
- Status last verified
- Jan 2022
- First submitted
- 7 Sep 2005
- 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 Randomized, Open Label, Cross-Over Study Comparing Effectiveness for the Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics
- ClinicalTrials.gov ID
- NCT00157937
- Acronym / sponsor ID
- 0476-329
- Conditions
- Asthma, Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 12 Sep 2005 (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.
Subjects have 8-week with montelukast sodium or comparator drug administration period, 2-week wash-out period and 8-week comparator drug or the drug administration period (with cross-over design) for assessment of the drug efficacy, safety and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Males or females between the ages of 18 and 60 with mild to moderate asthma
Key exclusion criteria (0 listed)
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: 16 weeks | Drug | – |
| Comparator: theophylline ER/Duration of Treatment: 16 weeks | Drug | – |
Primary outcome
FEV1
1 secondary outcome
AM-PEFR; daytime symptom score; treatment frequency of beta agonist; global assessment investigator's symptom assessment; Quality of Life Questionnaire for Adult Korean Asthmatics; QLQAKA
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; montelukast sodium/Duration of Treatment: 16 weeks and Comparator: theophylline ER/Duration of Treatment: 16 weeks in people with Asthma and Allergic Rhinitis, 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 1 inclusion and 0 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?
FEV1. 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.