AsthmaPhase 3NCT00461032

Montelukast Back to School Asthma Study (0476-340)

A Phase 3 study testing montelukast 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 study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school. Read more about this study

Who is it for?: Ages 6 to 14 years
Conditions the study is for: Asthma
What is being tested?: montelukast
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,162 participants
Where: No sites listed yet
Study dates: Jun 2006to Nov 2006
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 to 14 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male and female non-smoking Participants, ages 6 to 14 years, with chronic asthma, history of at least one asthma exacerbation associated with a cold within the past year and a documented history of asthma that required treatment with any asthma medication within 6 months prior to Visit 1

Who cannot join

Participant cannot have any other acute or chronic pulmonary disorder, or hospitalization for asthma more than three times within one year prior to signing informed consent

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Parallel Group 8-week Study to Evaluate the Efficacy and Safety of Chewable Montelukast When Initiated at the Start of the School Year in Pediatric Patients With Chronic Asthma

This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.

Conditions: Asthma
Being tested: montelukast, Comparator: Placebo
Medical subject headings: Asthma

What participants receive

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

montelukastDrug
montelukast 5 mg tablet Once a day (QD) for 8 weeks
Comparator: PlaceboDrug
Placebo to montelukast QD for 8 weeks

Study groups in NCT00461032
Study group	Role	What they receive
1	Experimental	montelukast Receives: Drug: montelukast
2	Placebo comparator	Placebo Receives: Drug: Comparator: Placebo

What is being measured

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

Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
A day of worsening asthma is a day with: increase from baseline in β-agonist use (> 70% and a min increase of 2 puffs); > 50% increase from baseline in daytime symptoms score; awake "all night"; increase from baseline in inhaled corticosteroid use ≥ 100% or oral corticosteroid rescue for worsening asthma; or unanticipated healthcare utilization.
Measured: 8 Week treatment period initiated at the beginning of a school year

Secondary outcomes (3)

Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries)
Health care utilization is defined as unanticipated asthma care in an office or clinic, emergent or hospital setting.
Measured: 8 Week treatment period initiated at the beginning of a school year
Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
Measured: 8 Week treatment period initiated at the beginning of a school year
Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
Daytime asthma symptom score was calculated as the sum of the responses (0 (best) to 5 (worst)) to three daytime symptom questions.
Measured: 8 Week treatment period initiated at the beginning of a school year

Timeline

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

Jun 2006Nov 2006

First posted17 Apr 2007 (estimated)
Study startJun 2006
Primary completionNov 2006
Study completionNov 2006

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: 1,162 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00461032
Sponsor's protocol ID: 0476-340
Other IDs: MK0476-340, 2007_539
Status last verified: Jan 2022
First submitted: 13 Apr 2007
Last updated: 2 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Weiss KB, Gern JE, Johnston NW, Sears MR, Jones CA, Jia G, Watkins MW, Smugar SS, Edelman JM, Grant EN. The Back to School asthma study: the effect of montelukast on asthma burden when initiated prophylactically at the start of the school year. Ann Allergy Asthma Immunol. 2010 Aug;105(2):174-81. doi: 10.1016/j.anai.2010.04.018. Epub 2010 Jul 1.
PubMed 20674830

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 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Parallel Group 8-week Study to Evaluate the Efficacy and Safety of Chewable Montelukast When Initiated at the Start of the School Year in Pediatric Patients With Chronic Asthma
ClinicalTrials.gov ID: NCT00461032
Acronym / sponsor ID: 0476-340
Conditions: Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,162 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Jun 2006
Primary completion: Nov 2006 (actual)
Study completion: Nov 2006 (actual)
First posted: 17 Apr 2007 (estimated)
Results: Posted 4 Feb 2010

Clinical summary

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

This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: montelukastmontelukast
2	Placebo comparator	Drug: Comparator: PlaceboPlacebo

Who may qualify

Ages: 6 to 14 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

Male and female non-smoking Participants, ages 6 to 14 years, with chronic asthma, history of at least one asthma exacerbation associated with a cold within the past year and a documented history of asthma that required treatment with any asthma medication within 6 months prior to Visit 1

Key exclusion criteria (1 listed)

Participant cannot have any other acute or chronic pulmonary disorder, or hospitalization for asthma more than three times within one year prior to signing informed consent

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
montelukastmontelukast 5 mg tablet Once a day (QD) for 8 weeks	Drug	1
Comparator: PlaceboPlacebo to montelukast QD for 8 weeks	Drug	2

Primary outcome

Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
Time frame: 8 Week treatment period initiated at the beginning of a school year
A day of worsening asthma is a day with: increase from baseline in β-agonist use (> 70% and a min increase of 2 puffs); > 50% increase from baseline in daytime symptoms score; awake "all night"; increase from baseline in inhaled corticosteroid use ≥ 100% or oral corticosteroid rescue for worsening asthma; or unanticipated healthcare utilization.

3 secondary outcomes

Number of Participants With the Occurrence of One or More Health Care Utilizations (as Measured on Daily Diaries)
Time frame: 8 Week treatment period initiated at the beginning of a school year
Percentage of Days With Increased β-agonist Use by >70% and a Minimum Increase of 2 Puffs From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
Time frame: 8 Week treatment period initiated at the beginning of a school year
Percentage of Days With Increased Daytime Asthma Symptom Score by >50% From Baseline (as Measured on Daily Diaries) in Pediatric Asthmatic Participants
Time frame: 8 Week treatment period initiated at the beginning of a school year

Results and safety

Results posted to the registry on 4 Feb 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
Placebo	582	545
Montelukast 5 mg	580	536

Primary outcome: Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants

Time frame: 8 Week treatment period initiated at the beginning of a school year. Least squares mean (95% Confidence Interval). Unit: Percentage of Days

Measure	Placebo n = 499	Montelukast 5 mg n = 499
Value	27.23 (24.25 to 30.00)	24.26 (21.52 to 27.01)

Population analysed: The primary efficacy analysis was based on full-analysis-set (FAS) population. This included all randomized participants who received at least one dose of double-blinded therapy and had a valid efficacy measurement. The percent of worsening asthma days was calculated from at least 7 days of diary data. Missing diary data were not imputed.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected during the 8 week, double-blind treatment period, and up to and including 14 days after the last dose of study therapy. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 566 (0.2%)	189 of 566 (33.4%)	Not reported
Montelukast 5 mg	4 of 566 (0.7%)	191 of 566 (33.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20674830Weiss KB, Gern JE, Johnston NW, Sears MR, Jones CA, Jia G, Watkins MW, Smugar SS, Edelman JM, Grant EN. The Back to School asthma study: the effect of montelukast on asthma burden when initiated prophylactically at the start of the school year. Ann Allergy Asthma Immunol. 2010 Aug;105(2):174-81. doi: 10.1016/j.anai.2010.04.018. Epub 2010 Jul 1.

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
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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 3 study testing montelukast 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 1 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. 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 4 Feb 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?

Mean Percentage of Days With Worsening Asthma (as Measured on Daily Diaries) in Pediatric Asthmatic Participants (time frame: 8 Week treatment period initiated at the beginning of a school year). 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 NCT00461032, 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.