Status:

COMPLETED

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)

Lead Sponsor:

Organon and Co

Conditions:

Asthma

Eligibility:

All Genders

18-65 years

Phase:

PHASE1

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

August 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2008

Estimated Enrollment :

46 Patients enrolled

Trial Details

Trial ID

NCT00636207

Start Date

August 1 2007

End Date

October 1 2008

Last Update

May 9 2024

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