AsthmaPhase 4NCT00140946
A Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients (0476-075)
A Phase 4 study testing MK0476; montelukast sodium/Duration of Treatment: 16 weeks in people with Asthma, run by Organon and Co.
Trial summary
A study to assess the clinical effect of montelukast sodium with concomitant administration of inhaled budesonide in asthmatic patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- MK0476; montelukast sodium/Duration of Treatment: 16 weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 546 participants
- Where
- No sites listed yet
- Study dates
- Mar 1998to Oct 2000
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females between the ages of 18 and 70 with asthma
Who cannot join
None listed.
About this study
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Two-Period, Parallel-group Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients.
A study to assess the clinical effect of montelukast sodium with concomitant administration of inhaled budesonide in asthmatic patients.
- Conditions
- Asthma
- Being tested
- MK0476; montelukast sodium/Duration of Treatment: 16 weeks, Comparator: placebo / Duration of Treatment: 16 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: 16 weeksDrug
Comparator: placebo / Duration of Treatment: 16 weeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of days of asthma exacerbations
Secondary outcomes (3)
Percentage of asthma free days
Percentage of nocturnal awakenings
Beta agonist use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startMar 1998
- Primary completionOct 2000
- Study completionOct 2000
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 546 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
- NCT00140946
- Sponsor's protocol ID
- 0476-075
- Other IDs
- MK0476-075, 2005_057
- Status last verified
- Feb 2022
- First submitted
- 30 Aug 2005
- Last updated
- 2 Feb 2022
- Results posted
- No
Publications
Vaquerizo MJ, Casan P, Castillo J, Perpina M, Sanchis J, Sobradillo V, Valencia A, Verea H, Viejo JL, Villasante C, Gonzalez-Esteban J, Picado C; CASIOPEA (Capacidad de Singulair Oral en la Prevencion de Exacerbaciones Asmaticas) Study Group. Effect of montelukast added to inhaled budesonide on control of mild to moderate asthma. Thorax. 2003 Mar;58(3):204-10. doi: 10.1136/thorax.58.3.204.
PubMed 12612294
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Two-Period, Parallel-group Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients.
- ClinicalTrials.gov ID
- NCT00140946
- Acronym / sponsor ID
- 0476-075
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 546 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Mar 1998
- Primary completion
- Oct 2000 (actual)
- Study completion
- Oct 2000 (actual)
- First posted
- 1 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.
A study to assess the clinical effect of montelukast sodium with concomitant administration of inhaled budesonide in asthmatic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males or females between the ages of 18 and 70 with 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: placebo / Duration of Treatment: 16 weeks | Drug | – |
Primary outcome
Percentage of days of asthma exacerbations
3 secondary outcomes
Percentage of asthma free days
Percentage of nocturnal awakenings
Beta agonist use
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 Feb 2022.
- Results publication: PubMed 12612294Vaquerizo MJ, Casan P, Castillo J, Perpina M, Sanchis J, Sobradillo V, Valencia A, Verea H, Viejo JL, Villasante C, Gonzalez-Esteban J, Picado C; CASIOPEA (Capacidad de Singulair Oral en la Prevencion de Exacerbaciones Asmaticas) Study Group. Effect of montelukast added to inhaled budesonide on control of mild to moderate asthma. Thorax. 2003 Mar;58(3):204-10. doi: 10.1136/thorax.58.3.204.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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 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 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 2 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.
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?
Percentage of days of asthma exacerbations. 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 NCT00140946, 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 Feb 2022.