AsthmaPhase 3NCT00337675

Intermittent and Daily Dosing for Episodic (Periodic) Asthma (0476-302)(COMPLETED)

A Phase 3 study testing montelukast sodium in people with Asthma, run by Organon and Co.

Completed

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

Trial summary

This is a year-long study evaluating the efficacy of both daily and intermittent treatment of asthma in children who experience symptoms episodically (i.e., seasonally, usually in the context of upper respiratory tract infection). Read more about this study

Who is it for?: Ages 6 months to 5 years
Conditions the study is for: Asthma
What is being tested?: montelukast sodium
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,771 participants
Where: No sites listed yet
Study dates: Oct 2006to Aug 2009
Phase: Phase 3
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 6 months to 5 years
All sexes
No healthy volunteers
Child

Who may be able to join

Patients aged 6 months to 5 years with episodic (periodic) asthma

Who cannot join

Patients who are not in otherwise good health
Patients who have persistent asthma (continual asthma symptoms)

About this study

Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study Evaluating the Effects of 2 Different Regimens of Montelukast (Daily Dosing and Intermittent, Episode-Driven Dosing) Compared With Placebo in the Treatment of Episodic Asthma in Children Aged 6 Months to 5 Years

Conditions: Asthma
Being tested: montelukast sodium, Comparator: Placebo (unspecified)
Medical subject headings: Asthma

What participants receive

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

montelukast sodiumDrug
Also called MK0476, Singulair®
Montelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period.
Comparator: Placebo (unspecified)Drug
Placebo (Pbo) qd + episode driven supplemental Pbo for 12 days for a 52-wk treatment period.
montelukast sodiumDrug
Also called MK0476, Singulair®
Pbo qd + episode driven supplemental Montelukast 4 mg (or 5 mg, depending on age of patient) qd for 12 days for a 52-wk treatment period.

Study groups in NCT00337675
Study group	Role	What they receive
Arm 1: drug + episodic supplemental placebo	Active comparator	Montelukast once a day (qd) + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period Receives: Drug: montelukast sodium
Arm 2: placebo comparator + episodic supplemental drug	Active comparator	Placebo qd + episode driven supplemental Montelukast qd for 12 days for a 52-wk treatment period Receives: Drug: montelukast sodium
Arm 3: placebo comparator + episodic supplemental placebo	Placebo comparator	Placebo qd + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period Receives: Drug: Comparator: Placebo (unspecified)

What is being measured

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

Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period
The rate per year of asthma episodes culminating in an asthma attack for each of the 3 treatment groups. Asthma attacks were defined as respiratory symptoms requiring healthcare resource utilization (HRU), which comprised unscheduled visits to a physician or emergency department, treatment with corticosteroids (oral, rectal, or inhaled), or hospitalization. Each day during an episode, the patient's legal guardian recorded all the HRU that was required specifically for breathing problems.
Measured: 1-year treatment period

Secondary outcomes (2)

Daily Average of Wheeze and Difficulty Breathing in the 3 Days Prior to Start of an Asthma Attack Within an Asthma Episode
Each day during an asthma episode, the patient's legal guardian was asked to rate each of the symptoms of wheeze and difficulty breathing on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 3 days prior to an asthma attack was reported. If a patient had multiple episodes during 1 year, the symptom scores were averaged across all the episodes.
Measured: 1 Year
Daily Average of the Mean Symptom Scores (Wheeze, Difficulty Breathing, Interference With Activity, and Daytime Cough) Assessed Over the 12-day Treatment Period of Asthma Episodes
Each day during an asthma episode, the patient's legal guardian was asked to rate each of the symptoms of Wheeze, Difficulty Breathing, Interference with Activity, and Daytime Cough on a 6-point scale (Scale 0 (best) to 5 (worst)). The average of the individual symptom scores on each of the 12 days of intermittent treatment for an episode (before the first attack) was reported. If a patient had multiple episodes over 1 year, the symptom scores were averaged across all the episodes.
Measured: 1 Year

Timeline

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

Oct 2006Aug 2009

First posted16 Jun 2006 (estimated)
Study startOct 2006
Primary completionAug 2009
Study completionAug 2009

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.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,771 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00337675
Sponsor's protocol ID: 0476-302
Other IDs: MK0476-302, 2006_015
Status last verified: Jan 2022
First submitted: 14 Jun 2006
Last updated: 10 May 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Publications

Valovirta E, Boza ML, Robertson CF, Verbruggen N, Smugar SS, Nelsen LM, Knorr BA, Reiss TF, Philip G, Gurner DM. Intermittent or daily montelukast versus placebo for episodic asthma in children. Ann Allergy Asthma Immunol. 2011 Jun;106(6):518-26. doi: 10.1016/j.anai.2011.01.017. Epub 2011 Mar 4.
PubMed 21624752

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

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

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study Evaluating the Effects of 2 Different Regimens of Montelukast (Daily Dosing and Intermittent, Episode-Driven Dosing) Compared With Placebo in the Treatment of Episodic Asthma in Children Aged 6 Months to 5 Years
ClinicalTrials.gov ID: NCT00337675
Acronym / sponsor ID: 0476-302
Conditions: Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,771 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Oct 2006
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 16 Jun 2006 (estimated)
Results: Posted 15 Mar 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Arm 1: drug + episodic supplemental placebo	Active comparator	Drug: montelukast sodiumMontelukast once a day (qd) + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period
Arm 2: placebo comparator + episodic supplemental drug	Active comparator	Drug: montelukast sodiumPlacebo qd + episode driven supplemental Montelukast qd for 12 days for a 52-wk treatment period
Arm 3: placebo comparator + episodic supplemental placebo	Placebo comparator	Drug: Comparator: Placebo (unspecified)Placebo qd + episode driven supplemental placebo qd for 12 days for a 52-wk treatment period

Who may qualify

Ages: 6 months to 5 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

Patients aged 6 months to 5 years with episodic (periodic) asthma

Key exclusion criteria (2 listed)

Patients who are not in otherwise good health
Patients who have persistent asthma (continual asthma symptoms)

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: MK0476, Singulair®Montelukast 4 mg (or 5 mg, depending on age of patient) qd + episode driven supplemental Pbo qd for 12 days for a 52-wk treatment period.	Drug	Arm 1: drug + episodic supplemental placebo
Comparator: Placebo (unspecified)Placebo (Pbo) qd + episode driven supplemental Pbo for 12 days for a 52-wk treatment period.	Drug	Arm 3: placebo comparator + episodic supplemental placebo
montelukast sodiumAlso: MK0476, Singulair®Pbo qd + episode driven supplemental Montelukast 4 mg (or 5 mg, depending on age of patient) qd for 12 days for a 52-wk treatment period.	Drug	Arm 2: placebo comparator + episodic supplemental drug

Primary outcome

Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period
Time frame: 1-year treatment period
The rate per year of asthma episodes culminating in an asthma attack for each of the 3 treatment groups. Asthma attacks were defined as respiratory symptoms requiring healthcare resource utilization (HRU), which comprised unscheduled visits to a physician or emergency department, treatment with corticosteroids (oral, rectal, or inhaled), or hospitalization. Each day during an episode, the patient's legal guardian recorded all the HRU that was required specifically for breathing problems.

2 secondary outcomes

Daily Average of Wheeze and Difficulty Breathing in the 3 Days Prior to Start of an Asthma Attack Within an Asthma Episode
Time frame: 1 Year
Daily Average of the Mean Symptom Scores (Wheeze, Difficulty Breathing, Interference With Activity, and Daytime Cough) Assessed Over the 12-day Treatment Period of Asthma Episodes
Time frame: 1 Year

Results and safety

Results posted to the registry on 15 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Daily Montelukast	589	492
Intermittent Montelukast	591	488
Placebo	591	492

Primary outcome: Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period

Time frame: 1-year treatment period. Mean (95% Confidence Interval). Unit: Asthma attacks within episodes per year

Measure	Daily Montelukast n = 584	Intermittent Montelukast n = 588	Placebo n = 585
Value	0.99 (0.86 to 1.14)	1.06 (0.92 to 1.22)	1.05 (0.92 to 1.20)

Daily Montelukast vs Placebo: Rate reduction: 5.3 (95% CI -11.4 to 19.6), p = 0.510, Regression, Poisson
Intermittent Montelukast vs Placebo: Rate reduction: -1.2 (95% CI -19.2 to 14.0), p = 0.884, Regression, Poisson

Population analysed: Full Analysis Set (FAS): all randomized patients who took at least one dose of blinded study drug. Of 1771 patients randomized, 5 never took study drug and 9 were not included due to Good Clinical Practice compliance concerns. Therefore, 1757 patients were included in the FAS population.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: October 2006 through August 2009. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Daily Montelukast	28 of 584 (4.8%)	481 of 584 (82.4%)	Not reported
Intermittent Montelukast	41 of 588 (7%)	506 of 588 (86.1%)	Not reported
Placebo	33 of 585 (5.6%)	486 of 585 (83.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21624752Valovirta E, Boza ML, Robertson CF, Verbruggen N, Smugar SS, Nelsen LM, Knorr BA, Reiss TF, Philip G, Gurner DM. Intermittent or daily montelukast versus placebo for episodic asthma in children. Ann Allergy Asthma Immunol. 2011 Jun;106(6):518-26. doi: 10.1016/j.anai.2011.01.017. Epub 2011 Mar 4.
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
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 3 study testing montelukast sodium 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 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 10 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 15 Mar 2010). 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?

Number of Asthma Episodes Culminating in Asthma Attack Over the 1-year Treatment Period (time frame: 1-year 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 NCT00337675, 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 10 May 2024.