AsthmaNCT00802789
Montelukast in Chronic Asthma
An observational study of Asthma, run by Organon and Co.
Trial summary
Treatment of patients insufficiently treated with ICS or ICS + LABA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Oct 2008
- Phase
- Observational
- 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
Study population: Mild to moderate adult asthmatics (≥18 years of age) insufficiently treated with ICS or ICS + LABA
Who may be able to join
- Patients Insufficiently Treated With ICS Or ICS + LABA.
Who cannot join
None listed.
About this study
Official title: Montelukast in Chronic Asthma: Non-interventional Study With Montelukast 10 mg
Treatment of patients insufficiently treated with ICS or ICS + LABA.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Mild to moderate adult asthmatics (≥18years of age) insufficiently treated with ICS or ICS + LABA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation of asthma control via ACT (Asthma Control Test).
Measured: 6 months (12 months optional)
Secondary outcomes (1)
Mini Asthma Quality of Life Questionnaire (Mini AQLQ).
Measured: 6 months (12 months optional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startApr 2007
- Primary completionSep 2008
- Study completionOct 2008
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 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
- NCT00802789
- Sponsor's protocol ID
- 0476-421
- Other IDs
- 2008_031, MK-0476-421
- Status last verified
- Feb 2022
- First submitted
- 4 Dec 2008
- Last updated
- 18 Feb 2022
- Results posted
- No
Publications
Virchow JC, Mehta A, Ljungblad L, Mitfessel H; MONICA study group. Add-on montelukast in inadequately controlled asthma patients in a 6-month open-label study: the MONtelukast In Chronic Asthma (MONICA) study. Respir Med. 2010 May;104(5):644-51. doi: 10.1016/j.rmed.2009.11.022. Epub 2009 Dec 23.
PubMed 20031382
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Montelukast in Chronic Asthma: Non-interventional Study With Montelukast 10 mg
- ClinicalTrials.gov ID
- NCT00802789
- Acronym / sponsor ID
- 0476-421
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 5 Dec 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.
Treatment of patients insufficiently treated with ICS or ICS + LABA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Mild to moderate adult asthmatics (≥18years of age) insufficiently treated with ICS or ICS + LABA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mild to moderate adult asthmatics (≥18 years of age) insufficiently treated with ICS or ICS + LABA
Key inclusion criteria (1 listed)
- Patients Insufficiently Treated With ICS Or ICS + LABA.
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.
Primary outcome
Documentation of asthma control via ACT (Asthma Control Test).
Time frame: 6 months (12 months optional)
1 secondary outcome
Mini Asthma Quality of Life Questionnaire (Mini AQLQ).
Time frame: 6 months (12 months optional)
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 18 Feb 2022.
- Results publication: PubMed 20031382Virchow JC, Mehta A, Ljungblad L, Mitfessel H; MONICA study group. Add-on montelukast in inadequately controlled asthma patients in a 6-month open-label study: the MONtelukast In Chronic Asthma (MONICA) study. Respir Med. 2010 May;104(5):644-51. doi: 10.1016/j.rmed.2009.11.022. Epub 2009 Dec 23.
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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?
An observational study of 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 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 18 Feb 2022. 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.
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?
Documentation of asthma control via ACT (Asthma Control Test). (time frame: 6 months (12 months optional)). 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 NCT00802789, 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 18 Feb 2022.