AsthmaPhase 4NCT00442559

Montelukast in Mild Asthmatic Children With Allergic Rhinitis (0476-367)

A Phase 4 study testing montelukast sodium and inhaled corticosteroid in people with Asthma and Allergic Rhinitis, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess real-world effectiveness of montelukast in children (2 to 14 years) with asthma and allergic rhinitis. Read more about this study

Who is it for?: Ages 2 to 14 years
Conditions the study is for: Asthma, Allergic Rhinitis
What is being tested?: montelukast sodium and inhaled corticosteroid
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 191 participants
Where: No sites listed yet
Study dates: Jan 2005to Oct 2007
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 2 to 14 years
All sexes
No healthy volunteers
Child

Who may be able to join

Between 2 and 14 years old
Diagnosed with asthma, classified as mild persistent asthma according to Global Initiative Asthma Guidelines (GINA)
Diagnosed with comorbid allergic rhinitis

Who cannot join

Patients with suspected sinus infection
Prior treatment with high dose inhaled corticosteroid requiring a dose higher than beclomethasone dipropionate 400 ug per day, or equivalent, other medications used in severe cases

About this study

Official title: Korean Study of "Real-World" Montelukast Use in Mild Asthmatic Children With Concomitant Allergic Rhinitis

The purpose of this study is to assess real-world effectiveness of montelukast in children (2 to 14 years) with asthma and allergic rhinitis.

Conditions: Asthma, Allergic Rhinitis
Being tested: montelukast sodium, inhaled corticosteroid
Medical subject headings: Asthma, Rhinitis, Allergic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

montelukast sodiumDrug
Also called Singulair, MK0476
Montelukast 4/5 mg tablet (oral chewable), once daily, 12 weeks to up to 12 months
inhaled corticosteroidDrug
Inhaled corticosteroid solution, 1-4 puffs daily, 12 weeks to up to 12 months

Study groups in NCT00442559
Study group	Role	What they receive
Montelukast	Experimental	Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks. Receives: Drug: montelukast sodium
Inhaled Corticosteroids (ICS)	Active comparator	Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks. Receives: Drug: inhaled corticosteroid

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline for Daytime Asthma Symptom Score
The score is an ordinal scale from 0 (no symptoms) to 5 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome.
Measured: Baseline and Week 12

Secondary outcomes (1)

Change From Baseline for Daily Allergic Rhinitis Symptom Score
The score is an ordinal scale from 0 (no symptoms) to 3 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome.
Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2005Oct 2007

First posted2 Mar 2007 (estimated)
Study startJan 2005
Primary completionOct 2007
Study completionOct 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: None (open label)
Enrolment: 191 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00442559
Sponsor's protocol ID: 0476-367
Other IDs: 2007_003
Status last verified: Jan 2022
First submitted: 28 Feb 2007
Last updated: 13 May 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Korean Study of "Real-World" Montelukast Use in Mild Asthmatic Children With Concomitant Allergic Rhinitis
ClinicalTrials.gov ID: NCT00442559
Acronym / sponsor ID: 0476-367
Conditions: Asthma, Allergic Rhinitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 191 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Jan 2005
Primary completion: Oct 2007 (actual)
Study completion: Oct 2007 (actual)
First posted: 2 Mar 2007 (estimated)
Results: Posted 18 Nov 2008

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 real-world effectiveness of montelukast in children (2 to 14 years) with asthma and allergic rhinitis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Montelukast	Experimental	Drug: montelukast sodiumParticipants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
Inhaled Corticosteroids (ICS)	Active comparator	Drug: inhaled corticosteroidParticipants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.

Who may qualify

Ages: 2 to 14 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Between 2 and 14 years old
Diagnosed with asthma, classified as mild persistent asthma according to Global Initiative Asthma Guidelines (GINA)
Diagnosed with comorbid allergic rhinitis

Key exclusion criteria (2 listed)

Patients with suspected sinus infection
Prior treatment with high dose inhaled corticosteroid requiring a dose higher than beclomethasone dipropionate 400 ug per day, or equivalent, other medications used in severe cases

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
montelukast sodiumAlso: Singulair, MK0476Montelukast 4/5 mg tablet (oral chewable), once daily, 12 weeks to up to 12 months	Drug	Montelukast
inhaled corticosteroidInhaled corticosteroid solution, 1-4 puffs daily, 12 weeks to up to 12 months	Drug	Inhaled Corticosteroids (ICS)

Primary outcome

Change From Baseline for Daytime Asthma Symptom Score
Time frame: Baseline and Week 12
The score is an ordinal scale from 0 (no symptoms) to 5 (most symptoms). The change was calculated as the score at 12 weeks minus the score at baseline. Thus, a negative value for change from baseline indicates a favorable outcome.

1 secondary outcome

Change From Baseline for Daily Allergic Rhinitis Symptom Score
Time frame: Baseline and Week 12

Results and safety

Results posted to the registry on 18 Nov 2008, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Montelukast	100	66
Inhaled Corticosteroids (ICS)	91	56

Primary outcome: Change From Baseline for Daytime Asthma Symptom Score

Time frame: Baseline and Week 12. Mean (Standard Deviation). Unit: Units on scale

Measure	Daytime Asthma Symptom Score at Baseline - Montelukast n = 24	Daytime Asthma Symptom Score at 12 Weeks - Montelukast n = 24	Daytime Asthma Symptom Score at Baseline - ICS n = 29	Daytime Asthma Symptom Score at 12 Weeks - ICS n = 29
Value	0.32 (0.42)	0.16 (0.35)	0.29 (0.4)	0.13 (0.27)

Daytime Asthma Symptom Score at Baseline - Montelukast vs Daytime Asthma Symptom Score at 12 Weeks - Montelukast: Mean Difference (Final Values): -0.16 (95% CI -0.29 to -0.03), p = 0.015, t-test, 2 sided
Daytime Asthma Symptom Score at Baseline - ICS vs Daytime Asthma Symptom Score at 12 Weeks - ICS: Mean Difference (Final Values): -0.16 (95% CI -0.3 to -0.02), p = 0.027, t-test, 2 sided

Population analysed: The primary efficacy parameter was a mean change from baseline to treatment for daytime asthma symptom score. Therefore 138 participants who didn't have a daytime asthma symptom score from the participant diary were not included.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 12 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Montelukast	4 of 100 (4%)	83 of 100 (83%)	Not reported
Inhaled Corticosteroids (ICS)	3 of 91 (3.3%)	70 of 91 (76.9%)	Not reported

Limitations and caveats (from the sponsor): This was an open-label study. Only 53 patients had diary information with daytime asthma symptom score - thus, 138 cases were dropped from analysis due to lack of daytime asthma symptom score.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
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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
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RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
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Active, not recruitingPhase 2/3
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RecruitingPhase 2
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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 4 study testing montelukast sodium and inhaled corticosteroid in people with Asthma and Allergic Rhinitis, 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 3 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 13 May 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 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?

Yes. Results are posted in the registry (first posted 18 Nov 2008). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline for Daytime Asthma Symptom Score (time frame: Baseline and Week 12). 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 NCT00442559.

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 13 May 2024.