AsthmaPhase 4NCT00395408
Linear Growth Study (0476-097)(COMPLETED)
A Phase 4 study testing MK0476, montelukast sodium / Duration of Treatment : 56 Weeks and Comparator : beclomethasone dipropionate / Duration of Treatment : 56 Weeks in people with Asthma, run by Organon and Co.
Trial summary
The purpose of this study is to compare the effect of montelukast with placebo and beclomethasone on the average rate of linear growth over a period of 56 weeks in children with mild asthma. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Asthma
- What is being tested?
- MK0476, montelukast sodium / Duration of Treatment : 56 Weeks and Comparator : beclomethasone dipropionate / Duration of Treatment : 56 Weeks
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- Jun 2000to Dec 2003
- 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 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Boys (aged 6 to 8 years at Visit 1) at Tanner Stage I (prepuberty)
- Girls (aged 6 to 7 years at Visit 1) at Tanner Stage I (prepuberty
- With at least a 6-month history of asthma with typical symptoms (including, but not limited to cough, wheeze, and shortness of breath, with periodic episodes requiring treatment with inhaled beta-agonists)
Who cannot join
- Patients who used more than 2 courses of inhaled corticosteroids within the 12 months prior to Visit 1
About this study
Official title: A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing the Effect on Linear Growth of Montelukast With Placebo and Inhaled Beclomethasone in Pediatric Patients (Prepubertal, Tanner Stage I) With Mild Asthma
The purpose of this study is to compare the effect of montelukast with placebo and beclomethasone on the average rate of linear growth over a period of 56 weeks in children with mild asthma.
- Conditions
- Asthma
- Being tested
- MK0476, montelukast sodium / Duration of Treatment : 56 Weeks, Comparator : beclomethasone dipropionate / Duration of Treatment : 56 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 : 56 WeeksDrug
Comparator : beclomethasone dipropionate / Duration of Treatment : 56 WeeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the difference in the average rate of linear growth over the 56-week double-blind treatment period between the montelukast and placebo groups
Secondary outcomes (6)
To evaluate the effects of montelukast in comparison with placebo and beclomethasone on FEV1
Beta-agonist use
Oral corticosteroid rescues for asthma
Discontinuations due to asthma
Peripheral blood eosinophil count
Markers of bone turn-over
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2006 (estimated)
- Study startJun 2000
- Primary completionDec 2003
- Study completionDec 2003
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
- Enrolment
- 360 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
- NCT00395408
- Sponsor's protocol ID
- 0476-097
- Other IDs
- 2006_550
- Status last verified
- Feb 2022
- First submitted
- 1 Nov 2006
- Last updated
- 14 Aug 2024
- Results posted
- No
Publications
Becker AB, Kuznetsova O, Vermeulen J, Soto-Quiros ME, Young B, Reiss TF, Dass SB, Knorr BA; Pediatric Montelukast Linear Growth Study Group. Linear growth in prepubertal asthmatic children treated with montelukast, beclomethasone, or placebo: a 56-week randomized double-blind study. Ann Allergy Asthma Immunol. 2006 Jun;96(6):800-7. doi: 10.1016/s1081-1206(10)61342-7.
PubMed 16802767
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing the Effect on Linear Growth of Montelukast With Placebo and Inhaled Beclomethasone in Pediatric Patients (Prepubertal, Tanner Stage I) With Mild Asthma
- ClinicalTrials.gov ID
- NCT00395408
- Acronym / sponsor ID
- 0476-097
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Jun 2000
- Primary completion
- Dec 2003 (actual)
- Study completion
- Dec 2003 (actual)
- First posted
- 2 Nov 2006 (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.
The purpose of this study is to compare the effect of montelukast with placebo and beclomethasone on the average rate of linear growth over a period of 56 weeks in children with mild asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Boys (aged 6 to 8 years at Visit 1) at Tanner Stage I (prepuberty)
- Girls (aged 6 to 7 years at Visit 1) at Tanner Stage I (prepuberty
- With at least a 6-month history of asthma with typical symptoms (including, but not limited to cough, wheeze, and shortness of breath, with periodic episodes requiring treatment with inhaled beta-agonists)
Key exclusion criteria (1 listed)
- Patients who used more than 2 courses of inhaled corticosteroids within the 12 months prior to Visit 1
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 : 56 Weeks | Drug | – |
| Comparator : beclomethasone dipropionate / Duration of Treatment : 56 Weeks | Drug | – |
Primary outcome
To establish the difference in the average rate of linear growth over the 56-week double-blind treatment period between the montelukast and placebo groups
6 secondary outcomes
To evaluate the effects of montelukast in comparison with placebo and beclomethasone on FEV1
Beta-agonist use
Oral corticosteroid rescues for asthma
Discontinuations due to asthma
Peripheral blood eosinophil count
Markers of bone turn-over
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 14 Aug 2024.
- Background: PubMed 16802767Becker AB, Kuznetsova O, Vermeulen J, Soto-Quiros ME, Young B, Reiss TF, Dass SB, Knorr BA; Pediatric Montelukast Linear Growth Study Group. Linear growth in prepubertal asthmatic children treated with montelukast, beclomethasone, or placebo: a 56-week randomized double-blind study. Ann Allergy Asthma Immunol. 2006 Jun;96(6):800-7. doi: 10.1016/s1081-1206(10)61342-7.
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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 MK0476, montelukast sodium / Duration of Treatment : 56 Weeks and Comparator : beclomethasone dipropionate / Duration of Treatment : 56 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 3 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 14 Aug 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?
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?
To establish the difference in the average rate of linear growth over the 56-week double-blind treatment period between the montelukast and placebo groups. 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 NCT00395408, 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 14 Aug 2024; AzTrials last refreshed its copy on 27 Oct 2026.