AsthmaPhase 3NCT00117338

A Study of an Intravenous Drug in Pediatric Patients With Acute Asthma (0476-301)

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 study will attempt to find out if the addition of an intravenous form of a drug that is already used for treating asthma in children will help resolve asthma attacks faster than using the current standard care alone. 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 sodium
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 276 participants
Where: No sites listed yet
Study dates: Jul 2005to Mar 2008
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

Children 6-14 years of age seeking treatment in emergency departments with acute asthma attacks

Who cannot join

Other respiratory conditions (including congenital lung abnormalities) or other acute illnesses that would complicate current treatment and response for asthma

About this study

Official title: A Multicenter, Randomized, Double-Blind Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Pediatric Patients (Ages 6 to 14 Years) With Acute Asthma

Read the detailed description

The duration of treatment is a one time dose.

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 IV 5.25 mg lyophilized (reconstituted in 20 mL of 3.3% dextrose/0.3% sodium chloride) for a study approximately 120 minutes in duration
Comparator: placebo (unspecified)Drug
Pbo for a study approximately 120 minutes in duration

Study groups in NCT00117338
Study group	Role	What they receive
1	Placebo comparator	Placebo Receives: Drug: Comparator: placebo (unspecified)
2	Active comparator	montelukast sodium Receives: Drug: montelukast sodium

What is being measured

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

Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration
Improvement in FEV1 as the time-weighted average change from baseline over 60 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 60 minutes (at 60, 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.
Measured: Baseline and (time weighted average over) 60 Minutes

Secondary outcomes (6)

Change From Baseline in Modified Pulmonary Index [mPI] Score
Change from baseline in modified pulmonary index [mPI] score assessed 60 minutes following the end of study drug administration. mPI questionnaire scores each component on a scale of 0 to 3 (low to high) with a total possible score of 12.
The components are respiratory rate, wheezing, prolongation of expiration (Inspiratory:Expiratory ratio), and accessory muscle use.
Measured: Baseline and 60 minutes
Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours)
Treatment Failure is defined as a.) patients who required hospitalization, or b.) patients for whom a decision to discharge home has not been reached by 2 hours following the end of study drug administration.
Measured: 120 minutes
Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration
Improvement in FEV1 as time-weighted average change from baseline over 45 minutes following the end of study drug administration: Time-weighted average of the changes from baseline obtained over the 45 minutes (at 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.
Measured: Baseline and (time-weighed average over) 45 Minutes
Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration
Improvement in FEV1 as the time-weighted average change from baseline over 30 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 30 minutes (at 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.
Measured: Baseline and (time-weighted average over) 30 Minutes
Change in FEV1 After 15 Minutes Following the End of Study Drug Administration
Improvement in FEV1 as the time-weighted average change from baseline over the first 15 minutes following the end of study drug administration. Change = 15 minutes value minus Baseline value
Measured: Baseline and 15 Minutes
Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration
Median total dose of β-agonist administered per patient over a period of 2 hours following the end of study drug administration.
Measured: 120 minutes

Timeline

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

Jul 2005Mar 2008

First posted6 Jul 2005 (estimated)
Study startJul 2005
Primary completionMar 2008
Study completionMar 2008

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: 276 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00117338
Sponsor's protocol ID: 0476-301
Other IDs: MK0476-301, 2005_026
Status last verified: Jan 2022
First submitted: 30 Jun 2005
Last updated: 10 May 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

Publications

Morris CR, Becker AB, Pinieiro A, Massaad R, Green SA, Smugar SS, Gurner DM. A randomized, placebo-controlled study of intravenous montelukast in children with acute asthma. Ann Allergy Asthma Immunol. 2010 Feb;104(2):161-71. doi: 10.1016/j.anai.2009.11.065.
PubMed 20306820

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
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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
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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 Study Comparing the Clinical Effects of Intravenous Montelukast With Placebo in Pediatric Patients (Ages 6 to 14 Years) With Acute Asthma
ClinicalTrials.gov ID: NCT00117338
Acronym / sponsor ID: 0476-301
Conditions: Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 276 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Jul 2005
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 6 Jul 2005 (estimated)
Results: Posted 11 Aug 2009

Clinical summary

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

Detailed description

The duration of treatment is a one time dose.

Study design

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

Arm	Type	Receives
1	Placebo comparator	Drug: Comparator: placebo (unspecified)Placebo
2	Active comparator	Drug: montelukast sodiummontelukast sodium

Who may qualify

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

Key inclusion criteria (1 listed)

Children 6-14 years of age seeking treatment in emergency departments with acute asthma attacks

Key exclusion criteria (1 listed)

Other respiratory conditions (including congenital lung abnormalities) or other acute illnesses that would complicate current treatment and response for asthma

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 IV 5.25 mg lyophilized (reconstituted in 20 mL of 3.3% dextrose/0.3% sodium chloride) for a study approximately 120 minutes in duration	Drug	2
Comparator: placebo (unspecified)Pbo for a study approximately 120 minutes in duration	Drug	1

Primary outcome

Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration
Time frame: Baseline and (time weighted average over) 60 Minutes
Improvement in FEV1 as the time-weighted average change from baseline over 60 minutes following the end of study drug administration. Time-weighted average of the changes from baseline obtained over the 60 minutes (at 60, 45, 30 and 15) with the time interval between any measurement and the measurement prior to it used as the weighting factor.

6 secondary outcomes

Change From Baseline in Modified Pulmonary Index [mPI] Score
Time frame: Baseline and 60 minutes
Number of Participants With Treatment Failure (Hospitalization or Time to Decision to Discharge > 2 Hours)
Time frame: 120 minutes
Time-Weighted Average Change in FEV1 Over 45 Minutes Following the End of Study Drug Administration
Time frame: Baseline and (time-weighed average over) 45 Minutes
Time-Weighted Average Change in FEV1 Over 30 Minutes Following the End of Study Drug Administration
Time frame: Baseline and (time-weighted average over) 30 Minutes
Change in FEV1 After 15 Minutes Following the End of Study Drug Administration
Time frame: Baseline and 15 Minutes
Total Dose of β-agonist Administered Per Patient Over a Period of 2 Hours Following the End of Study Drug Administration
Time frame: 120 minutes

Results and safety

Results posted to the registry on 11 Aug 2009, 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 Intravenous (IV) 5.25 mg	145	140
Placebo	131	127

Primary outcome: Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration

Time frame: Baseline and (time weighted average over) 60 Minutes. Least squares mean (95% Confidence Interval). Unit: Liters

Measure	Montelukast Intravenous (IV) 5.25 mg n = 144	Placebo n = 128
Value	0.08 (0.02 to 0.13)	0.07 (0.01 to 1.12)

Montelukast Intravenous (IV) 5.25 mg vs Placebo: Mean Difference (Final Values): 0.01 (95% CI -0.06 to 0.08), p = 0.775, ANCOVA

Population analysed: Full Analysis Set (FAS). The FAS population includes all randomized patients who received double-blind study drug, and with efficacy measurements both at baseline and at least one time point over the time interval considered.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Montelukast Intravenous (IV) 5.25 mg	2 of ?	20 of ?	Not reported
Placebo	2 of ?	21 of ?	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.
Derived from this study: PubMed 20306820Morris CR, Becker AB, Pinieiro A, Massaad R, Green SA, Smugar SS, Gurner DM. A randomized, placebo-controlled study of intravenous montelukast in children with acute asthma. Ann Allergy Asthma Immunol. 2010 Feb;104(2):161-71. doi: 10.1016/j.anai.2009.11.065.
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 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 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 11 Aug 2009). 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?

Improvement in FEV1 (Forced Expiratory Volume in 1 Second) Over the First 60 Minutes After Administration (time frame: Baseline and (time weighted average over) 60 Minutes). 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 NCT00117338, 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.