Pulmonary Disease, Chronic ObstructivePhase 2NCT00482235
A Study of MK0359 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0359-016)
A Phase 2 study testing MK0359 in people with Pulmonary Disease, Chronic Obstructive, run by Merck Sharp & Dohme LLC.
Trial summary
A study to test the effect of MK0359 in lessening the symptoms of COPD as compared to salmeterol and placebo. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- MK0359
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Dec 2002to Apr 2003
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You are between the ages of 40 and 75
- You have had a history for at least a year of COPD symptoms
- You have a history of smoking one pack of cigarettes per day for 10 years
Who cannot join
- You have been in a research study with an investigational drug or vaccine in the last 4 weeks.
- You have donated blood in the last 4 weeks.
- You have been hospitalized or had major surgery in the last 4 weeks
- You have been treated in the emergency room within the last 2 months or hospitalized within the last 3 months for your COPD symptoms
- You have a history of heart problems in the last 6 months
- You have a history of stomach problems
- You are unwilling to avoid grapefruit juice throughout the study
About this study
A study to test the effect of MK0359 in lessening the symptoms of COPD as compared to salmeterol and placebo.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- MK0359
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0359Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2007 (estimated)
- Study startDec 2002
- Primary completionApr 2003
- Study completionApr 2003
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 Pulmonary Disease, Chronic ObstructiveStudies 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 45 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
- NCT00482235
- Sponsor's protocol ID
- 0359-016
- Other IDs
- 2007_569
- Status last verified
- Nov 2015
- First submitted
- 1 Jun 2007
- Last updated
- 2 Dec 2015
- Results posted
- No
Publications
Lu S, Liu N, Dass SB, Reiss TF, Knorr BA. Randomized, placebo-controlled study of a selective PDE4 inhibitor in the treatment of asthma. Respir Med. 2009 Mar;103(3):342-7. doi: 10.1016/j.rmed.2008.10.024. Epub 2009 Jan 8.
PubMed 19135348
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of MK0359 in Patients With Chronic Obstructive Pulmonary Disease (COPD)(0359-016)
- ClinicalTrials.gov ID
- NCT00482235
- Acronym / sponsor ID
- 0359-016
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Apr 2003 (actual)
- Study completion
- Apr 2003 (actual)
- First posted
- 5 Jun 2007 (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.
A study to test the effect of MK0359 in lessening the symptoms of COPD as compared to salmeterol and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- You are between the ages of 40 and 75
- You have had a history for at least a year of COPD symptoms
- You have a history of smoking one pack of cigarettes per day for 10 years
Key exclusion criteria (7 listed)
- You have been in a research study with an investigational drug or vaccine in the last 4 weeks.
- You have donated blood in the last 4 weeks.
- You have been hospitalized or had major surgery in the last 4 weeks
- You have been treated in the emergency room within the last 2 months or hospitalized within the last 3 months for your COPD symptoms
- You have a history of heart problems in the last 6 months
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 |
|---|---|---|
| MK0359 | Drug | – |
Primary outcome
Not reported in the source record.
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 2 Dec 2015.
- Results publication: PubMed 19135348Lu S, Liu N, Dass SB, Reiss TF, Knorr BA. Randomized, placebo-controlled study of a selective PDE4 inhibitor in the treatment of asthma. Respir Med. 2009 Mar;103(3):342-7. doi: 10.1016/j.rmed.2008.10.024. Epub 2009 Jan 8.
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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 MK0359 in people with Pulmonary Disease, Chronic Obstructive, 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 3 inclusion and 7 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 2 Dec 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00482235, 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 2 Dec 2015.