AsthmaPhase 2NCT00783601
MK0524 Asthma POC Study (0524-008)(COMPLETED)
A Phase 2 study testing Comparator: MK0524 + montelukast in people with Asthma, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of the study is to demonstrate the benefit of MK0524 compared to placebo in patients with chronic asthma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Asthma
- What is being tested?
- Comparator: MK0524 + montelukast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- Oct 2004to May 2005
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has symptoms of chronic asthma (shortness of breath, wheezing, chest tightness, etc.) for at least 1 year
- Nonsmoker for at least 1 year with a smoking history of no more than 7 pack-years (i.e., 1 pack per day for 7 years)
Who cannot join
- Any clinically significant disease of heart, intestinal, kidney, liver, lung or uncontrolled blood pressure
- Any surgery within 4 weeks prior to Visit 1
- Patient is intending to move or vacation for more than 5 days during the study
- Patient is pregnant or breast-feeding
About this study
Official title: A Multicenter, Randomized, Double Blind, Crossover Study Comparing the Effect of MK0524 With Placebo and Concomitant Administration of MK0524 Plus Montelukast in Adult Patients With Chronic Asthma
The purpose of the study is to demonstrate the benefit of MK0524 compared to placebo in patients with chronic asthma.
- Conditions
- Asthma
- Being tested
- Comparator: MK0524 + placebo, Comparator: MK0524 + montelukast, Comparator: placebo + montelukast, Comparator: Placebo
- Keywords
- Chronic Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: MK0524 + placeboDrug
Two 150 mg MK0524 tablets + one placebo tablet in the matching image of montelukast 10 mg once daily for 3 weeks
Comparator: MK0524 + montelukastDrug
Two 150 mg MK0524 tablets and one 10 mg montelukast tablet once daily for 2 weeks
Comparator: placebo + montelukastDrug
Two placebo tablets in the matching image of MK0524 150 mg and one 10 mg tablet montelukast once daily for 2 weeks
Comparator: PlaceboDrug
During the double-blind treatment periods, patients receive either two placebo tablets in the matching image of MK0524 150 mg or one placebo tablet in the matching image of montelukast 10 mg in a crossover manner. During the washout period before the crossover to the opposite treatment sequence, patients receive two placebo tablets in the matching image of MK0524 150 mg and one placebo tablet in the matching image of montelukast 10 mg once daily for two weeks.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment Sequence 1: MK0524 + placebo, MK0524 + montelukast, placebo, placebo, placebo + montelukast Receives: Drug: Comparator: MK0524 + placebo; Drug: Comparator: MK0524 + montelukast; Drug: Comparator: placebo + montelukast; Drug: Comparator: Placebo |
| 2 | Experimental | Treatment sequence 2: Placebo, montelukast, placebo, MK0524, MK0524 + montelukast Receives: Drug: Comparator: MK0524 + placebo; Drug: Comparator: MK0524 + montelukast; Drug: Comparator: placebo + montelukast; Drug: Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate benefits of MK0524 compared with placebo on Forced Expiratory Volume in 1 second (FEV1)
Measured: Last 2 weeks of each treatment period
Secondary outcomes (1)
To determine the benefits of MK0524 as compared with placebo on the key secondary endpoints (Daytime & Nighttime Asthma Symptoms scores
Measured: Last 2 weeks of each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startOct 2004
- Primary completionMay 2005
- Study completionMay 2005
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.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- 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
- NCT00783601
- Sponsor's protocol ID
- 0524-008
- Other IDs
- MK0524-008, 2007_614
- Status last verified
- Oct 2015
- First submitted
- 30 Oct 2008
- Last updated
- 16 Oct 2015
- Results posted
- No
Publications
Philip G, van Adelsberg J, Loeys T, Liu N, Wong P, Lai E, Dass SB, Reiss TF. Clinical studies of the DP1 antagonist laropiprant in asthma and allergic rhinitis. J Allergy Clin Immunol. 2009 Nov;124(5):942-8.e1-9. doi: 10.1016/j.jaci.2009.07.006. Epub 2009 Sep 12.
PubMed 19748656
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blind, Crossover Study Comparing the Effect of MK0524 With Placebo and Concomitant Administration of MK0524 Plus Montelukast in Adult Patients With Chronic Asthma
- ClinicalTrials.gov ID
- NCT00783601
- Acronym / sponsor ID
- 0524-008
- Conditions
- Asthma
- Keywords
- Chronic Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2004
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 31 Oct 2008 (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 the study is to demonstrate the benefit of MK0524 compared to placebo in patients with chronic asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Comparator: MK0524 + placebo, Drug: Comparator: MK0524 + montelukast, Drug: Comparator: placebo + montelukast, Drug: Comparator: PlaceboTreatment Sequence 1: MK0524 + placebo, MK0524 + montelukast, placebo, placebo, placebo + montelukast |
| 2 | Experimental | Drug: Comparator: MK0524 + placebo, Drug: Comparator: MK0524 + montelukast, Drug: Comparator: placebo + montelukast, Drug: Comparator: PlaceboTreatment sequence 2: Placebo, montelukast, placebo, MK0524, MK0524 + montelukast |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has symptoms of chronic asthma (shortness of breath, wheezing, chest tightness, etc.) for at least 1 year
- Nonsmoker for at least 1 year with a smoking history of no more than 7 pack-years (i.e., 1 pack per day for 7 years)
Key exclusion criteria (4 listed)
- Any clinically significant disease of heart, intestinal, kidney, liver, lung or uncontrolled blood pressure
- Any surgery within 4 weeks prior to Visit 1
- Patient is intending to move or vacation for more than 5 days during the study
- Patient is pregnant or breast-feeding
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 |
|---|---|---|
| Comparator: MK0524 + placeboTwo 150 mg MK0524 tablets + one placebo tablet in the matching image of montelukast 10 mg once daily for 3 weeks | Drug | 1, 2 |
| Comparator: MK0524 + montelukastTwo 150 mg MK0524 tablets and one 10 mg montelukast tablet once daily for 2 weeks | Drug | 1, 2 |
| Comparator: placebo + montelukastTwo placebo tablets in the matching image of MK0524 150 mg and one 10 mg tablet montelukast once daily for 2 weeks | Drug | 1, 2 |
| Comparator: PlaceboDuring the double-blind treatment periods, patients receive either two placebo tablets in the matching image of MK0524 150 mg or one placebo tablet in the matching image of montelukast 10 mg in a crossover manner. During the washout period before the crossover to the opposite treatment sequence, patients receive two placebo tablets in the matching image of MK0524 150 mg and one placebo tablet in the matching image of montelukast 10 mg once daily for two weeks. | Drug | 1, 2 |
Primary outcome
To demonstrate benefits of MK0524 compared with placebo on Forced Expiratory Volume in 1 second (FEV1)
Time frame: Last 2 weeks of each treatment period
1 secondary outcome
To determine the benefits of MK0524 as compared with placebo on the key secondary endpoints (Daytime & Nighttime Asthma Symptoms scores
Time frame: Last 2 weeks of each treatment period
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 16 Oct 2015.
- Derived from this study: PubMed 19748656Philip G, van Adelsberg J, Loeys T, Liu N, Wong P, Lai E, Dass SB, Reiss TF. Clinical studies of the DP1 antagonist laropiprant in asthma and allergic rhinitis. J Allergy Clin Immunol. 2009 Nov;124(5):942-8.e1-9. doi: 10.1016/j.jaci.2009.07.006. Epub 2009 Sep 12.
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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 2 study testing Comparator: MK0524 + montelukast in people with Asthma, run by Merck Sharp & Dohme LLC.
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 4 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 16 Oct 2015. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 demonstrate benefits of MK0524 compared with placebo on Forced Expiratory Volume in 1 second (FEV1) (time frame: Last 2 weeks of each 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 NCT00783601, 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 16 Oct 2015; AzTrials last refreshed its copy on 29 Oct 2026.