AsthmaPhase 3NCT00442338

Study of MK-0476 in Adult Patients With Acute Asthma (0476-334)

A Phase 3 study testing montelukast sodium and aminophylline hydrate 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

The study estimates the efficacy and safety of MK0476 and aminophylline intravenous administration in adult participants with acute asthma. Read more about this study

Who is it for?: Ages 15 to 75 years
Conditions the study is for: Asthma
What is being tested?: montelukast sodium and aminophylline hydrate
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: No sites listed yet
Study dates: Mar 2007to Aug 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 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Adult participants with acute asthma attacks

Who cannot join

Participant has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., COPD, chronic heart failure, etc.).
Participant has a smoking habit (15 cigarettes per day) within a month prior to screening period, and/or has a smoking history (20 cigarettes per day) of more than 15 years.
Participant has a disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe disease.

About this study

Official title: MK-476 IV Formulation Phase III Open Label Exploratory Comparative Study - Acute Exacerbations of Asthma -

The study estimates the efficacy and safety of MK0476 and aminophylline intravenous administration in adult participants with acute asthma.

Conditions: Asthma
Being tested: montelukast sodium, aminophylline hydrate
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
Montelukast 7 mg single injection (IV bolus administration) over 2-3 minutes
montelukast sodiumDrug
Also called MK-0476
Montelukast 14 mg single injection (IV bolus administration) over 5 minutes
aminophylline hydrateDrug
Also called Kyophyllin® Injection 2.5%, FK05
Aminophylline 250 mg IV drip infusion over 60 minutes

Study groups in NCT00442338
Study group	Role	What they receive
Montelukast 7 mg	Experimental	Montelukast 7 mg IV administration Receives: Drug: montelukast sodium
Montelukast 14 mg	Experimental	Montelukast 14 mg IV administration Receives: Drug: montelukast sodium
Aminophylline 250 mg	Active comparator	Aminophylline 250 mg IV drip administration Receives: Drug: aminophylline hydrate

What is being measured

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

Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration
The time weighted average change from Baseline in Forced Expiratory Volume in One Second (FEV1) over the first 60 minutes after study drug administration (average change FEV1 (0-60 min)). Baseline (pre-allocation) was the last measurement obtained during the screening period.
Measured: Baseline and 60 minutes after study drug administration

Timeline

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

Mar 2007Aug 2007

First posted1 Mar 2007 (estimated)
Study startMar 2007
Primary completionAug 2007
Study completionAug 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.
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: None (open label)
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00442338
Sponsor's protocol ID: 0476-334
Other IDs: MK-0476-334, 2007_007
Status last verified: Jan 2022
First submitted: 27 Feb 2007
Last updated: 2 Feb 2022
Results posted: Yes, on ClinicalTrials.gov

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

Official title: MK-476 IV Formulation Phase III Open Label Exploratory Comparative Study - Acute Exacerbations of Asthma -
ClinicalTrials.gov ID: NCT00442338
Acronym / sponsor ID: 0476-334
Conditions: Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Aug 2007 (actual)
Study completion: Aug 2007 (actual)
First posted: 1 Mar 2007 (estimated)
Results: Posted 14 Jul 2009

Clinical summary

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

The study estimates the efficacy and safety of MK0476 and aminophylline intravenous administration in adult participants with acute asthma.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Montelukast 7 mg	Experimental	Drug: montelukast sodiumMontelukast 7 mg IV administration
Montelukast 14 mg	Experimental	Drug: montelukast sodiumMontelukast 14 mg IV administration
Aminophylline 250 mg	Active comparator	Drug: aminophylline hydrateAminophylline 250 mg IV drip administration

Who may qualify

Ages: 15 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Adult participants with acute asthma attacks

Key exclusion criteria (3 listed)

Participant has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., COPD, chronic heart failure, etc.).
Participant has a smoking habit (15 cigarettes per day) within a month prior to screening period, and/or has a smoking history (20 cigarettes per day) of more than 15 years.
Participant 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 sodiumAlso: MK-0476Montelukast 7 mg single injection (IV bolus administration) over 2-3 minutes	Drug	Montelukast 7 mg
montelukast sodiumAlso: MK-0476Montelukast 14 mg single injection (IV bolus administration) over 5 minutes	Drug	Montelukast 14 mg
aminophylline hydrateAlso: Kyophyllin® Injection 2.5%, FK05Aminophylline 250 mg IV drip infusion over 60 minutes	Drug	Aminophylline 250 mg

Primary outcome

Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration
Time frame: Baseline and 60 minutes after study drug administration
The time weighted average change from Baseline in Forced Expiratory Volume in One Second (FEV1) over the first 60 minutes after study drug administration (average change FEV1 (0-60 min)). Baseline (pre-allocation) was the last measurement obtained during the screening period.

Results and safety

Results posted to the registry on 14 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	30	30
Montelukast 14 mg	30	30
Aminophylline 250 mg	31	31

Primary outcome: Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration

Time frame: Baseline and 60 minutes after study drug administration. Least squares mean (95% Confidence Interval). Unit: Liter

Measure	Montelukast 7 mg n = 27	Montelukast 14 mg n = 30	Aminophylline 250 mg n = 29
Value	0.07 (0.02 to 0.12)	0.05 (0.00 to 0.11)	0.06 (0.01 to 0.12)

Montelukast 7 mg vs Aminophylline 250 mg: Difference in LS Means: 0.01 (95% CI -0.07 to 0.08), p = 0.871, ANCOVA
Montelukast 14 mg vs Aminophylline 250 mg: Difference in LS Means: -0.01 (95% CI -0.08 to 0.06), p = 0.794, ANCOVA
Montelukast 7 mg vs Montelukast 14 mg: Difference in LS Means: 0.02 (95% CI -0.06 to 0.09), p = 0.675, ANCOVA

Population analysed: Per Protocol Set (PPS): subset of participants who comply with the protocol sufficiently to ensure that these data will likely exhibit effects of treatment, according to the underlying scientific model. Aminophylline 250 mg - 1 participant with no FEV1 data at 60 minutes was excluded from the analysis.

Adverse events

Time frame: From Screening through post-trial visit (up to 14 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Montelukast 7 mg	3 of 30 (10%)	5 of 30 (16.7%)	Not reported
Montelukast 14 mg	0 of 30 (0%)	1 of 30 (3.3%)	Not reported
Aminophylline 250 mg	1 of 31 (3.2%)	3 of 31 (9.7%)	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.

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 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 aminophylline hydrate 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 14 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?

Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Within the First 60 Minutes After Administration (time frame: Baseline and 60 minutes after study drug administration). 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 NCT00442338.

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.