Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 46
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: Participants receive Montelukast inhalation powder, 0.1 mg.

* Part I: Administered as a single dose followed by at least a 3-day washout period. arm 2: Participants receive Montelukast inhalation powder, 0.3 mg.

* Part I: Administered as a single dose followed by at least a 3-day washout period. arm 3: 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. arm 4: 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. arm 5: 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. arm 6: 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.

Interventions: intervention 1: Montelukast intervention 2: Placebo
Intervention descriptions: intervention 1: Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg intervention 2: Placebo dry powder inhaler

Protocol document: