AsthmaPhase 3NCT00229970

MK0476 Study in Adult Patients With Acute Asthma (0476-322)

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 evaluates the efficacy and safety of MK0476 intravenous administration in adult patients with acute asthma. Read more about this study

Who is it for?: Ages 15 to 65 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: 225 participants
Where: No sites listed yet
Study dates: Sep 2005to Jun 2007
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 15 to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Adult Patients With Acute Asthma Attacks

Who cannot join

Patient Has Any Known Or Suspected, Acute Or Chronic Cause For Their Pulmonary Symptoms Other Than Asthma (E.G., Copd, Chronic Heart Failure, Etc.)
Patient Has A Smoking History (20 Cigarettes Per Day) Of More Than 15 Years
Patient Has A Disease Of The Cardiovascular, Hepatic, Renal, Hematologic Systems, Or Other Severe Disease

About this study

Official title: MK0476 Phase II/III Placebo Controlled Double Blind Study

This study evaluates the efficacy and safety of MK0476 intravenous administration in adult patients with acute asthma.

Conditions: Asthma
Being tested: montelukast sodium, 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.

montelukast sodiumDrug
7 mg or 14 mg single injection
Comparator: PlaceboDrug
Placebo single injection

Study groups in NCT00229970
Study group	Role	What they receive
1	Experimental	Placebo Receives: Drug: Comparator: Placebo
2	Experimental	MK0476 7 mg injection Receives: Drug: montelukast sodium
3	Experimental	MK0476 14 mg injection Receives: Drug: montelukast sodium

What is being measured

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

The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1)
The Time Weighed Average Changes in Forced Expiratory Volume in One Second (FEV1) from pre-allocation baseline over the first 60 minutes after study drug administration with time interval between any measurement and the measurement prior to it is used as the weighting factor
Measured: baseline over the first 60 minutes

Timeline

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

Sep 2005Jun 2007

First posted30 Sep 2005 (estimated)
Study startSep 2005
Primary completionOct 2006
Study completionJun 2007

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: 225 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00229970
Sponsor's protocol ID: 0476-322
Other IDs: MK0476-322, 2005_084
Status last verified: Jan 2022
First submitted: 28 Sep 2005
Last updated: 2 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Adachi M, Taniguchi H, Tohda Y, Sano Y, Ishine T, Smugar SS, Hisada S. The efficacy and tolerability of intravenous montelukast in acute asthma exacerbations in Japanese patients. J Asthma. 2012 Aug;49(6):649-56. doi: 10.3109/02770903.2012.690479. Epub 2012 Jun 28.
PubMed 22742205

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: MK0476 Phase II/III Placebo Controlled Double Blind Study
ClinicalTrials.gov ID: NCT00229970
Acronym / sponsor ID: 0476-322
Conditions: Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 225 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Sep 2005
Primary completion: Oct 2006 (actual)
Study completion: Jun 2007 (actual)
First posted: 30 Sep 2005 (estimated)
Results: Posted 17 Jul 2009

Clinical summary

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

This study evaluates the efficacy and safety of MK0476 intravenous administration in adult patients with acute asthma.

Study design

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

Arm	Type	Receives
1	Experimental	Drug: Comparator: PlaceboPlacebo
2	Experimental	Drug: montelukast sodiumMK0476 7 mg injection
3	Experimental	Drug: montelukast sodiumMK0476 14 mg injection

Who may qualify

Ages: 15 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Adult Patients With Acute Asthma Attacks

Key exclusion criteria (3 listed)

Patient Has Any Known Or Suspected, Acute Or Chronic Cause For Their Pulmonary Symptoms Other Than Asthma (E.G., Copd, Chronic Heart Failure, Etc.)
Patient Has A Smoking History (20 Cigarettes Per Day) Of More Than 15 Years
Patient Has A Disease Of The Cardiovascular, Hepatic, Renal, Hematologic Systems, Or Other Severe Disease

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 sodium7 mg or 14 mg single injection	Drug	2, 3
Comparator: PlaceboPlacebo single injection	Drug	1

Primary outcome

The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1)
Time frame: baseline over the first 60 minutes
The Time Weighed Average Changes in Forced Expiratory Volume in One Second (FEV1) from pre-allocation baseline over the first 60 minutes after study drug administration with time interval between any measurement and the measurement prior to it is used as the weighting factor

Results and safety

Results posted to the registry on 17 Jul 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 7 mg	78	78
Montelukast 14 mg	72	72
Placebo	75	75

Primary outcome: The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1)

Time frame: baseline over the first 60 minutes. Least squares mean (95% Confidence Interval). Unit: Liter

Measure	Montelukast 7 mg n = 78	Montelukast 14 mg n = 72	Placebo n = 75
Value	0.09 (0.04 to 0.15)	0.17 (0.12 to 0.23)	0.01 (-0.05 to 0.06)

Montelukast 7 mg vs Placebo: Mean Difference (Final Values): 0.09 (95% CI 0.01 to 0.16), p = 0.022, ANCOVA
Montelukast 14 mg vs Placebo: Mean Difference (Final Values): 0.17 (95% CI 0.09 to 0.24), p <0.001, ANCOVA

Population analysed: Last observed value during the 60 minutes treatment period was used in the Full Analysis Set (FAS)

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Montelukast 7 mg	2 of ?	23 of ?	Not reported
Montelukast 14 mg	4 of ?	11 of ?	Not reported
Placebo	4 of ?	13 of ?	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.
Derived from this study: PubMed 22742205Adachi M, Taniguchi H, Tohda Y, Sano Y, Ishine T, Smugar SS, Hisada S. The efficacy and tolerability of intravenous montelukast in acute asthma exacerbations in Japanese patients. J Asthma. 2012 Aug;49(6):649-56. doi: 10.3109/02770903.2012.690479. Epub 2012 Jun 28.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
Recruiting
THERMotherapy Against Persistent Bacterial LUNG Infections
Lung Diseases, Obstructive, Bronchiectasis
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
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 3 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. 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 17 Jul 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?

The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1) (time frame: baseline over the first 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 NCT00229970, 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; AzTrials last refreshed its copy on 8 Nov 2026.