PF-04191834 Single Dose Bronchodilatory Study In Asthma.

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.

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: PF-04191834; Drug: PF-04191834; Drug: PF-04191834; Drug: zileuton; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21225
      • Pfizer Investigational Site
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Pfizer Investigational Site
  • Michigan
    • Kalamazoo, Michigan, United States, 49007
      • Pfizer Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)	Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.
Maximum Observed Plasma Concentration (Cmax)		Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.
Time to Reach Maximum Observed Plasma Concentration (Tmax)		Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.
Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]	AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).	14 and 24 hours following dosing in each period.

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: July 24, 2008
• First Submitted That Met QC Criteria: July 24, 2008
• First Posted (Estimate): July 28, 2008

Study Record Updates

• Last Update Posted (Estimate): February 1, 2013
• Last Update Submitted That Met QC Criteria: December 27, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Bronchodilator
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Leukotriene Antagonists; Hormone Antagonists; Lipoxygenase Inhibitors; Zileuton
• Other Study ID Numbers: B0041002