CompletedPhase 1

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)

46 participantsStarted 2007-08

Plain-language summary

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

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Who Experienced At Least One Adverse Event

Timeframe: Up to 14 days after last dose of study drug

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

Timeframe: 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

Timeframe: Up to 24 hours postdose

AUC 0-24hr of Montelukast - Multiple Doses

Timeframe: Up to 24 hours postdose

Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose

Timeframe: Up to 24 hours postdose

Cmax of Montelukast - Multiple Doses

Timeframe: Up to 24 hours postdose

Time to Cmax (Tmax) of Montelukast - Single Dose

Timeframe: Up to 24 hours postdose

Trial details

NCT IDNCT00636207

SponsorOrganon and Co

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2008-09

Results submitted2012-12-20

View on ClinicalTrials.gov More Asthma trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants Who Experienced At Least One Adverse Event

Timeframe: Up to 14 days after last dose of study drug

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

Timeframe: 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

Timeframe: Up to 24 hours postdose

AUC 0-24hr of Montelukast - Multiple Doses

Timeframe: Up to 24 hours postdose

Maximum Plasma Concentration (Cmax) of Montelukast - Single Dose

Timeframe: Up to 24 hours postdose

Cmax of Montelukast - Multiple Doses

Timeframe: Up to 24 hours postdose

Time to Cmax (Tmax) of Montelukast - Single Dose

Timeframe: Up to 24 hours postdose