AsthmaPhase 3NCT00092144
Study of an Approved Drug in Patients With Asthma (0476-289)(COMPLETED)
A Phase 3 study testing MK0476, montelukast sodium / Duration of Treatment: 4 weeks in people with Asthma, run by Organon and Co.
Trial summary
The purpose of this study is to assess the efficacy and safety of an approved drug on asthma symptoms in patients with chronic asthma which is also active during the allergy season. 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, montelukast sodium / Duration of Treatment: 4 weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 26 Feb 2004to 15 Jun 2004
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Asthma symptoms brought on by allergies
Who cannot join
- Patient has any lung disease
- Currently have a sinus infection or cold symptoms
About this study
Official title: A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral MK0476 Vs Placebo During the Allergy Season in Patients With Seasonal Aeroallergen Sensitivity and Chronic Asthma Which is Also Active During Allergy Season
The purpose of this study is to assess the efficacy and safety of an approved drug on asthma symptoms in patients with chronic asthma which is also active during the allergy season.
- Conditions
- Asthma
- Being tested
- MK0476, montelukast sodium / Duration of Treatment: 4 weeks, Comparator: placebo / Duration of Treatment: 4 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: 4 weeksDrug
Comparator: placebo / Duration of Treatment: 4 weeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess daytime asthma symptoms as measured by daily diaries over a 3-week treatment period
Secondary outcomes (7)
To assess the following over a 3-week treatment period:
nighttime symptoms
AM PEFR
PM PEFR
B-agonist use
asthma attacks
discontinuations due to asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2004 (estimated)
- Study start26 Feb 2004
- Primary completion15 Jun 2004
- Study completion15 Jun 2004
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 500 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
- NCT00092144
- Sponsor's protocol ID
- 0476-289
- Other IDs
- 2004_028
- Status last verified
- Jan 2022
- First submitted
- 21 Sep 2004
- Last updated
- 15 Aug 2024
- Results posted
- No
Publications
Busse WW, Casale TB, Dykewicz MS, Meltzer EO, Bird SR, Hustad CM, Grant E, Zeldin RK, Edelman JM. Efficacy of montelukast during the allergy season in patients with chronic asthma and seasonal aeroallergen sensitivity. Ann Allergy Asthma Immunol. 2006 Jan;96(1):60-8. doi: 10.1016/S1081-1206(10)61041-1.
PubMed 16440534
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 Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Clinical Effect of Oral MK0476 Vs Placebo During the Allergy Season in Patients With Seasonal Aeroallergen Sensitivity and Chronic Asthma Which is Also Active During Allergy Season
- ClinicalTrials.gov ID
- NCT00092144
- Acronym / sponsor ID
- 0476-289
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 26 Feb 2004 (actual)
- Primary completion
- 15 Jun 2004 (actual)
- Study completion
- 15 Jun 2004 (actual)
- First posted
- 24 Sep 2004 (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.
The purpose of this study is to assess the efficacy and safety of an approved drug on asthma symptoms in patients with chronic asthma which is also active during the allergy season.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Asthma symptoms brought on by allergies
Key exclusion criteria (2 listed)
- Patient has any lung disease
- Currently have a sinus infection or cold symptoms
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: 4 weeks | Drug | – |
| Comparator: placebo / Duration of Treatment: 4 weeks | Drug | – |
Primary outcome
To assess daytime asthma symptoms as measured by daily diaries over a 3-week treatment period
7 secondary outcomes
To assess the following over a 3-week treatment period:
nighttime symptoms
AM PEFR
PM PEFR
B-agonist use
asthma attacks
discontinuations due to asthma
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 16440534Busse WW, Casale TB, Dykewicz MS, Meltzer EO, Bird SR, Hustad CM, Grant E, Zeldin RK, Edelman JM. Efficacy of montelukast during the allergy season in patients with chronic asthma and seasonal aeroallergen sensitivity. Ann Allergy Asthma Immunol. 2006 Jan;96(1):60-8. doi: 10.1016/S1081-1206(10)61041-1.
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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: 4 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 1 inclusion and 2 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?
To assess daytime asthma symptoms as measured by daily diaries over a 3-week treatment period. 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 NCT00092144, 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.