Asthma, BronchialPhase 3NCT00540839
A Study of Montelukast (MK-0476) Compared With Fluticasone in Pediatric Participants With Chronic Asthma (MK-0476-303)
A Phase 3 study testing Montelukast sodium and Fluticasone propionate in people with Asthma, Bronchial, run by Organon and Co.
Trial summary
A study to determine the effects of montelukast (MK-0476) on pediatric participants with chronic asthma compared with fluticasone. The primary hypotheses are that, over 24 weeks of treatment, montelukast will provide at least the same level of asthma control as inhaled fluticasone as measured by the percentage of days… Read more about this study
- Who is it for?
- Ages 6 months to 5 years
- Conditions the study is for
- Asthma, Bronchial
- What is being tested?
- Montelukast sodium and Fluticasone propionate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Mar 2008
- Phase
- Phase 3
- 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 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between 6 months and 5 years, 4 months of age
- Diagnosed with asthma by a doctor
- At least 3 episodes of asthma symptoms within the last 6 months
Who cannot join
- Active or chronic breathing disease, other than asthma
- Required insertion of a breathing tube for asthma
- Major surgery within the last 4 weeks
- Currently in the hospital
- Allergic to certain drugs, and for children under 2 years of age, apples, applesauce and formula
About this study
Official title: A Phase III Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Prospectively Evaluate Efficacy of Montelukast in Patients Aged 6 Months to 5 Years With Chronic Asthma
A study to determine the effects of montelukast (MK-0476) on pediatric participants with chronic asthma compared with fluticasone. The primary hypotheses are that, over 24 weeks of treatment, montelukast will provide at least the same level of asthma control as inhaled fluticasone as measured by the percentage of days without asthma and that, over 24 weeks of treatment, daily administration of montelukast will be safe and well tolerated in children aged 6 months to 5 years with chronic asthma.
This trial was stopped at a time before any participants had actually entered the trial. Based on input from regulatory agencies, it is not necessary to conduct this study; a separate ongoing study was sufficient for regulatory purposes.
Read the detailed description
This study consists of a 4-week placebo run-in period followed by a 24-week double-blind treatment period.
- Conditions
- Asthma, Bronchial
- Being tested
- Montelukast sodium, Placebo to montelukast, Fluticasone propionate, Placebo to fluticasone
- 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 MK-0476, Singulair®
Montelukast 4 mg OG or montelukast 4 mg CT
Placebo to montelukastDrug
Placebo OG or CT
Fluticasone propionateDrug
Fluticasone 50 mcg inhalation aerosol metered dose inhaler
Placebo to fluticasoneDrug
Placebo inhalation aerosol metered dose inhaler
| Study group | Role | What they receive |
|---|---|---|
| Montelukast | Experimental | Participants receive montelukast 4 mg oral granules (OG) or 4 mg chewable tablets (CT) once daily (QD) for 24 weeks and placebo to fluticasone 50 mcg inhalation aerosol twice daily (BID) for 24 weeks. Participants aged >6 months to <2 years receive montelukast 4 mg packet of OG QD for 24 weeks. Participants aged >2 years to <64 months receive montelukast 4 mg CT QD for 24 weeks. Receives: Drug: Montelukast sodium; Drug: Placebo to fluticasone |
| Fluticasone | Active comparator | Participants receive fluticasone 50 mcg inhalation aerosol twice daily (BID) for 24 weeks and placebo to montelukast 4 mg QD for 24 weeks. Participants aged >6 months to <2 years receive placebo packet of OG QD for 24 weeks. Participants aged >2 years to <64 months receive placebo CT QD for 24 weeks. Receives: Drug: Placebo to montelukast; Drug: Fluticasone propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of days without asthma
A day without asthma is defined as a day with all of the following: no daytime symptoms, no nighttime cough, no β-agonist use, and no asthma attack (defined as a visit to a doctor, urgent care clinic, emergency room, or hospital for asthma [other than a scheduled visit to a doctor], or treatment with systemic corticosteroid during the previous 24 hours).
Measured: 24 weeks
Number of participants who experience at least one adverse event (AE)
Measured: Up to 26 weeks
Number of participants who discontinue study drug due to an AE
Measured: Up to 24 weeks
Secondary outcomes (3)
Percentage of days without daytime symptoms
Measured: 24 weeks
Percentage of days without nighttime cough
Measured: 24 weeks
Percentage of days without β-agonist use
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionMar 2008
Why it stopped: Based on input from regulatory agencies, it is not necessary to conduct this study. An ongoing study was sufficient for regulatory purposes.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma, BronchialStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00540839
- Sponsor's protocol ID
- 0476-303
- Other IDs
- 2007_583
- Status last verified
- Jan 2022
- First submitted
- 4 Oct 2007
- Last updated
- 14 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Prospectively Evaluate Efficacy of Montelukast in Patients Aged 6 Months to 5 Years With Chronic Asthma
- ClinicalTrials.gov ID
- NCT00540839
- Acronym / sponsor ID
- 0476-303
- Conditions
- Asthma, Bronchial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Based on input from regulatory agencies, it is not necessary to conduct this study. An ongoing study was sufficient for regulatory purposes.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Mar 2008 (actual)
- First posted
- 8 Oct 2007 (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 determine the effects of montelukast (MK-0476) on pediatric participants with chronic asthma compared with fluticasone. The primary hypotheses are that, over 24 weeks of treatment, montelukast will provide at least the same level of asthma control as inhaled fluticasone as measured by the percentage of days without asthma and that, over 24 weeks of treatment, daily administration of montelukast will be safe and well tolerated in children aged 6 months to 5 years with chronic asthma.
This trial was stopped at a time before any participants had actually entered the trial. Based on input from regulatory agencies, it is not necessary to conduct this study; a separate ongoing study was sufficient for regulatory purposes.
Detailed description
This study consists of a 4-week placebo run-in period followed by a 24-week double-blind treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Montelukast | Experimental | Drug: Montelukast sodium, Drug: Placebo to fluticasoneParticipants receive montelukast 4 mg oral granules (OG) or 4 mg chewable tablets (CT) once daily (QD) for 24 weeks and placebo to fluticasone 50 mcg inhalation aerosol twice daily (BID) for 24 weeks. Participants aged >6 months to <2 years receive montelukast 4 mg packet of OG QD for 24 weeks. Participants aged >2 years to <64 months receive montelukast 4 mg CT QD for 24 weeks. |
| Fluticasone | Active comparator | Drug: Placebo to montelukast, Drug: Fluticasone propionateParticipants receive fluticasone 50 mcg inhalation aerosol twice daily (BID) for 24 weeks and placebo to montelukast 4 mg QD for 24 weeks. Participants aged >6 months to <2 years receive placebo packet of OG QD for 24 weeks. Participants aged >2 years to <64 months receive placebo CT QD for 24 weeks. |
Who may qualify
- Ages
- 6 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Between 6 months and 5 years, 4 months of age
- Diagnosed with asthma by a doctor
- At least 3 episodes of asthma symptoms within the last 6 months
Key exclusion criteria (5 listed)
- Active or chronic breathing disease, other than asthma
- Required insertion of a breathing tube for asthma
- Major surgery within the last 4 weeks
- Currently in the hospital
- Allergic to certain drugs, and for children under 2 years of age, apples, applesauce and formula
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: MK-0476, Singulair®Montelukast 4 mg OG or montelukast 4 mg CT | Drug | Montelukast |
| Placebo to montelukastPlacebo OG or CT | Drug | Fluticasone |
| Fluticasone propionateFluticasone 50 mcg inhalation aerosol metered dose inhaler | Drug | Fluticasone |
| Placebo to fluticasonePlacebo inhalation aerosol metered dose inhaler | Drug | Montelukast |
Primary outcome
Percentage of days without asthma
Time frame: 24 weeks
A day without asthma is defined as a day with all of the following: no daytime symptoms, no nighttime cough, no β-agonist use, and no asthma attack (defined as a visit to a doctor, urgent care clinic, emergency room, or hospital for asthma [other than a scheduled visit to a doctor], or treatment with systemic corticosteroid during the previous 24 hours).
Number of participants who experience at least one adverse event (AE)
Time frame: Up to 26 weeks
Number of participants who discontinue study drug due to an AE
Time frame: Up to 24 weeks
3 secondary outcomes
Percentage of days without daytime symptoms
Time frame: 24 weeks
Percentage of days without nighttime cough
Time frame: 24 weeks
Percentage of days without β-agonist use
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
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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 Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Montelukast sodium and Fluticasone propionate in people with Asthma, Bronchial, 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 5 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: withdrawn, as of the sponsor's last update on 14 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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 without asthma (time frame: 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2022.