AsthmaPhase 1NCT00636207

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Montelukast (MK-0476) in Participants With Mild or Moderate Asthma (MK-0476-380 AM3)(COMPLETED)

A Phase 1 study testing Montelukast 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

A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast (MK-0476) in participants with mild or moderate asthma. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Asthma
What is being tested?: Montelukast
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 46 participants
Where: No sites listed yet
Study dates: Aug 2007to Oct 2008
Phase: Phase 1
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female between the ages of 18 and 65
Must have mild or moderate asthma (Part III only)
Nonsmoker for at least 6 months

Who cannot join

History of stroke, chronic seizures or major neurological disorder
You are nursing
Drink more than 3 glasses of alcohol a day
Have allergy to or not able to tolerate lactose
Have a history of drug abuse in the last 5 years
Drink more than 6 beverages containing caffeine a day
Have had surgery, donated blood or participated in another investigational study in the last 4 weeks

About this study

Official title: A Sequential, 3-Part, Double-Blind, Randomized, Placebo-Controlled, Single-Rising-Dose and Rising-Multiple-Dose Study in Healthy Subjects and Mild or Moderate Asthmatic Patients to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled MK-0476

A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast (MK-0476) in participants with mild or moderate asthma.

Conditions: Asthma
Being tested: Montelukast, Placebo
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MontelukastDrug
Also called Montelukast Sodium, MK-0476
Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg
PlaceboDrug
Placebo dry powder inhaler

Study groups in NCT00636207
Study group	Role	What they receive
Montelukast 0.1 mg	Experimental	Participants receive Montelukast inhalation powder, 0.1 mg. * Part I: Administered as a single dose followed by at least a 3-day washout period. Receives: Drug: Montelukast
Montelukast 0.3 mg	Experimental	Participants receive Montelukast inhalation powder, 0.3 mg. * Part I: Administered as a single dose followed by at least a 3-day washout period. Receives: Drug: Montelukast
Montelukast 1 mg	Experimental	Participants receive Montelukast inhalation powder, 1 mg. * Part I: Administered as a single dose followed by at least a 3-day washout period. * Part II: Administered once daily (QD) for 5 days followed by at least a 3-day washout period. Receives: Drug: Montelukast
Montelukast 3 mg	Experimental	Participants receive Montelukast inhalation powder, 3 mg. * Part I: Administered as a single dose followed by at least a 3-day washout period. * Part II: Administered QD for 5 days followed by at least a 3-day washout period. * Part III: Administered QD for 10 days followed by at least a 7-day washout period. Receives: Drug: Montelukast
Montelukast 10 mg	Experimental	Participants receive Montelukast inhalation powder, 10 mg. * Part I: Administered as a single dose followed by at least a 3-day washout period. * Part II: Administered QD for 5 days followed by at least a 3-day washout period. * Part III: Administered QD for 10 days followed by at least a 7-day washout period. Receives: Drug: Montelukast
Placebo	Placebo comparator	Participants receive Placebo to Montelukast inhalation powder. * Part I: Administered as a single dose followed by at least a 3-day washout period. * Part II: Administered QD for 5 days followed by at least a 3-day washout period. * Part III: Administered QD for 10 days followed by at least a 7-day washout period. Receives: Drug: Placebo

What is being measured

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

Number of Participants Who Experienced At Least One Adverse Event
Measured: Up to 14 days after last dose of study drug
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Measured: Up to 7 days after last dose of study drug
Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose
Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
Measured: Up to 24 hours postdose
AUC 0-24hr of Montelukast - Multiple Doses
Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
Measured: Up to 24 hours postdose
Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose
Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
Measured: Up to 24 hours postdose
Cmax of Montelukast - Multiple Doses
Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
Measured: Up to 24 hours postdose
Time to Cmax (Tmax) of Montelukast - Single Dose
Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
Measured: Up to 24 hours postdose
Tmax of Montelukast - Multiple Doses
Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
Measured: Up to 24 hours postdose
Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose
Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
Measured: Up to 24 hours postdose
t1/2 of Montelukast - Multiple Doses
Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
Measured: Up to 24 hours postdose
AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses
The AUC 0-24hr Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of AUC 0-24hr on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III.
Measured: up to 10 days after first dose of study drug
Cmax Accumulation Ratio of Montelukast - Multiple Doses
The Cmax Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of Cmax on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III.
Measured: up to 10 days after first dose of study drug

Timeline

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

Aug 2007Oct 2008

First posted14 Mar 2008 (estimated)
Study startAug 2007
Primary completionSep 2008
Study completionOct 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.
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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00636207
Sponsor's protocol ID: 0476-380
Other IDs: 2008_516
Status last verified: Feb 2022
First submitted: 3 Mar 2008
Last updated: 9 May 2024
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: No

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

Active, not recruitingPhase 1
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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Sequential, 3-Part, Double-Blind, Randomized, Placebo-Controlled, Single-Rising-Dose and Rising-Multiple-Dose Study in Healthy Subjects and Mild or Moderate Asthmatic Patients to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled MK-0476
ClinicalTrials.gov ID: NCT00636207
Acronym / sponsor ID: 0476-380
Conditions: Asthma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Aug 2007
Primary completion: Sep 2008 (actual)
Study completion: Oct 2008 (actual)
First posted: 14 Mar 2008 (estimated)
Results: Posted 28 Jan 2013

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 evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast (MK-0476) in participants with mild or moderate asthma.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Montelukast 0.1 mg	Experimental	Drug: MontelukastParticipants receive Montelukast inhalation powder, 0.1 mg. * Part I: Administered as a single dose followed by at least a 3-day washout period.
Montelukast 0.3 mg	Experimental	Drug: MontelukastParticipants receive Montelukast inhalation powder, 0.3 mg. * Part I: Administered as a single dose followed by at least a 3-day washout period.
Montelukast 1 mg	Experimental	Drug: MontelukastParticipants receive Montelukast inhalation powder, 1 mg. * Part I: Administered as a single dose followed by at least a 3-day washout period. * Part II: Administered once daily (QD) for 5 days followed by at least a 3-day washout period.
Montelukast 3 mg	Experimental	Drug: MontelukastParticipants receive Montelukast inhalation powder, 3 mg. * Part I: Administered as a single dose followed by at least a 3-day washout period. * Part II: Administered QD for 5 days followed by at least a 3-day washout period. * Part III: Administered QD for 10 days followed by at least a 7-day washout period.
Montelukast 10 mg	Experimental	Drug: MontelukastParticipants receive Montelukast inhalation powder, 10 mg. * Part I: Administered as a single dose followed by at least a 3-day washout period. * Part II: Administered QD for 5 days followed by at least a 3-day washout period. * Part III: Administered QD for 10 days followed by at least a 7-day washout period.
Placebo	Placebo comparator	Drug: PlaceboParticipants receive Placebo to Montelukast inhalation powder. * Part I: Administered as a single dose followed by at least a 3-day washout period. * Part II: Administered QD for 5 days followed by at least a 3-day washout period. * Part III: Administered QD for 10 days followed by at least a 7-day washout period.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Male or female between the ages of 18 and 65
Must have mild or moderate asthma (Part III only)
Nonsmoker for at least 6 months

Key exclusion criteria (7 listed)

History of stroke, chronic seizures or major neurological disorder
You are nursing
Drink more than 3 glasses of alcohol a day
Have allergy to or not able to tolerate lactose
Have a history of drug abuse in the last 5 years

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
MontelukastAlso: Montelukast Sodium, MK-0476Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg	Drug	Montelukast 0.1 mg, Montelukast 0.3 mg, Montelukast 1 mg, Montelukast 10 mg, Montelukast 3 mg
PlaceboPlacebo dry powder inhaler	Drug	Placebo

Primary outcome

Number of Participants Who Experienced At Least One Adverse Event
Time frame: Up to 14 days after last dose of study drug
Number of Participants Who Discontinued Study Drug Due to an Adverse Event
Time frame: Up to 7 days after last dose of study drug
Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose
Time frame: Up to 24 hours postdose
Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
AUC 0-24hr of Montelukast - Multiple Doses
Time frame: Up to 24 hours postdose
Blood samples for assessment of AUC 0-24hr were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose
Time frame: Up to 24 hours postdose
Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
Cmax of Montelukast - Multiple Doses
Time frame: Up to 24 hours postdose
Blood samples for assessment of Cmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
Time to Cmax (Tmax) of Montelukast - Single Dose
Time frame: Up to 24 hours postdose
Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
Tmax of Montelukast - Multiple Doses
Time frame: Up to 24 hours postdose
Blood samples for assessment of Tmax were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
Apparent Terminal Half Life (t1/2) of Montelukast - Single Dose
Time frame: Up to 24 hours postdose
Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Day 1 in Part I.
t1/2 of Montelukast - Multiple Doses
Time frame: Up to 24 hours postdose
Blood samples for assessment of t1/2 were drawn predose and then at specified timepoints (up to 24 hours postdose) on Days 1 and 5 in Part II and on Days 1 and 10 in Part III.
AUC 0-24hr Accumulation Ratio of Montelukast - Multiple Doses
Time frame: up to 10 days after first dose of study drug
The AUC 0-24hr Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of AUC 0-24hr on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III.
Cmax Accumulation Ratio of Montelukast - Multiple Doses
Time frame: up to 10 days after first dose of study drug
The Cmax Accumulation Ratio of Montelukast was calculated as the geometric mean ratio of Cmax on the last day and the first day of a multiple dose regimen: Day 5/Day 1 in Part II and Day 10/Day 1 in Part III.

Results and safety

Results posted to the registry on 28 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part I - Montelukast	1	0
Part I - Montelukast and Placebo	8	7
Part II - Montelukast	18	18
Part II - Placebo	6	6
Part III - Montelukast	9	8
Part III - Montelukast and Placebo	1	1
Part III - Placebo	3	3

Primary outcome: Number of Participants Who Experienced At Least One Adverse Event

Time frame: Up to 14 days after last dose of study drug. Number. Unit: participants

Measure	Montelukast 0.1 mg n = 7	Montelukast 0.3 mg n = 7	Montelukast 1 mg n = 12	Montelukast 3 mg n = 18	Montelukast 10 mg n = 19	Placebo n = 18
Value	2	4	6	9	5	6

Population analysed: Safety Population: All participants who received at least one dose of study drug

Primary outcome: Number of Participants Who Discontinued Study Drug Due to an Adverse Event

Time frame: Up to 7 days after last dose of study drug. Number. Unit: participants

Measure	Montelukast 0.1 mg n = 7	Montelukast 0.3 mg n = 7	Montelukast 1 mg n = 12	Montelukast 3 mg n = 18	Montelukast 10 mg n = 19	Placebo n = 18
Value	0	1	0	0	0	0

Population analysed: Safety Population: All participants who received at least one dose of study drug

Primary outcome: Area Under the Curve From 0 to 24 Hours (AUC 0-24hr) of Montelukast - Single Dose

Time frame: Up to 24 hours postdose. Mean (Standard Deviation). Unit: ng/mL*hr

Measure	Montelukast 0.1 mg n = 7	Montelukast 0.3 mg n = 7	Montelukast 0.3 mg Repeat n = 5	Montelukast 1 mg n = 6	Montelukast 3 mg n = 6	Montelukast 10 mg n = 6
Value	NA (NA)	NA (NA)	NA (NA)	155 (18.5)	491 (71)	1600 (260)

Population analysed: Per Protocol Population: All participants who complied with the protocol

Primary outcome: AUC 0-24hr of Montelukast - Multiple Doses

Time frame: Up to 24 hours postdose. Mean (Standard Deviation). Unit: ng/mL*hr

Measure	Montelukast 1 mg n = 6	Montelukast 3 mg n = 6	Montelukast 10 mg n = 6
Part II Day 1 (n=6)	132 (43.7)	403 (115)	1576 (380)
Part II Day 5 (n=6)	214 (76.3)	576 (148)	1850 (304)
Part III Day 1 (n=6)	NA (NA)	357 (109)	1500 (521)
Part III Day 10 (n=6)	NA (NA)	526 (133)	1880 (530)

Population analysed: Per Protocol Population: All participants who complied with the protocol

Adverse events

Time frame: Up to 14 days after last dose of study drug. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Montelukast 0.1 mg	0 of 7 (0%)	2 of 7 (28.6%)	Not reported
Montelukast 0.3 mg	0 of 7 (0%)	4 of 7 (57.1%)	Not reported
Montelukast 1 mg	0 of 12 (0%)	6 of 12 (50%)	Not reported
Montelukast 3 mg	0 of 18 (0%)	9 of 18 (50%)	Not reported
Montelukast 10 mg	0 of 19 (0%)	5 of 19 (26.3%)	Not reported
Placebo	0 of 18 (0%)	6 of 18 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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 1 study testing Montelukast 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 7 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 9 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 28 Jan 2013). 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?

Number of Participants Who Experienced At Least One Adverse Event (time frame: Up to 14 days after last dose of study drug). The study lists 12 primary outcomes in all. 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 NCT00636207.

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 9 May 2024.