PF-04191834 Single Dose Bronchodilatory Study In Asthma.

Pfizer

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Placebo; Drug: zileuton; Drug: PF-04191834

Study type: Interventional

Funder types: Industry

Identifiers

NCT00723021

B0041002

Details and patient eligibility

About

Study to determine the bronchodilatory effects of PF-04191834 compared with zileuton in patients with asthma

Enrollment: 15 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Persistent mild/moderate asthma for at least 6 months.
• Reduced lung function
• Reversible airway obstruction

Exclusion criteria

• Pregnant/nursing females.
• Liver function tests greater than upper limit of normal (ULN)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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15 participants in 5 patient groups, including a placebo group

PF-04191834 30mg

Experimental group

Treatment:

Drug: PF-04191834

Drug: PF-04191834

Drug: PF-04191834

PF-04191834 100mg

Experimental group

Treatment:

Drug: PF-04191834

Drug: PF-04191834

Drug: PF-04191834

PF-04191834 2000mg

Experimental group

Treatment:

Drug: PF-04191834

Drug: PF-04191834

Drug: PF-04191834

zileuton

Active Comparator group

Treatment:

Drug: zileuton

placebo

Placebo Comparator group

Treatment:

Drug: Placebo