PF-04191834 Single Dose Bronchodilatory Study In Asthma.

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

Official Title
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A Phase 2a, Randomised, Double-Blind (3rd Party Open), Double-Dummy, Placebo And Active Controlled 5-Way Crossover Study To Assess The Bronchodilatory Action, Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-04191834 In Asthmatic Patients.

Conditions
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Asthma

Intervention / Treatment
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* Drug: PF-04191834
* Drug: PF-04191834
* Drug: PF-04191834
* Drug: zileuton
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-04191834 30mg<br> | Drug: PF-04191834<br>* 30mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets.<br>|
| Experimental: PF-04191834 100mg<br> | Drug: PF-04191834<br>* 100mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets, single dose.<br>|
| Experimental: PF-04191834 2000mg<br> | Drug: PF-04191834<br>* 2000mg PF-04191834, single dose, oral dispersion + 2 x placebo tables, single dose<br>|
| Active Comparator: zileuton<br> | Drug: zileuton<br>* 1200mg, 2 x 600mg tablets, single dose + placebo oral dispersion, single dose.<br>|
| Placebo Comparator: placebo<br> | Drug: Placebo<br>* 2 x placebo tablets + placebo oral dispersion, single dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | The FEV1 is the maximal volume of air that can be forcefully exhaled in one second | Baseline, 12 hours (hrs) post-dose | 
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | The FEV1 is the maximal volume of air that can be forcefully exhaled in one second | Baseline, 24 hours (hrs) post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Forced Vital Capacity (FVC) | The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible | Baseline, 12 hours (hrs) post-dose | 
| Change From Baseline in Forced Vital Capacity (FVC) | The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible | Baseline,24 hours (hrs) post-dose | 
| Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75) | The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity | Baseline, 12 hours (hrs) post-dose | 
| Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75) | The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity | Baseline, 24 hours (hrs) post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchodilator