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PF-04191834 Single Dose Bronchodilatory Study In Asthma.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00723021
First received: July 24, 2008
Last updated: December 27, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Asthma
Drug: PF-04191834
Drug: zileuton
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline, 12 hours (hrs) post-dose ] [ Designated as safety issue: No ]
    The FEV1 is the maximal volume of air that can be forcefully exhaled in one second

  • Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Baseline, 24 hours (hrs) post-dose ] [ Designated as safety issue: No ]
    The FEV1 is the maximal volume of air that can be forcefully exhaled in one second


Secondary Outcome Measures:
  • Change From Baseline in Forced Vital Capacity (FVC) [ Time Frame: Baseline, 12 hours (hrs) post-dose ] [ Designated as safety issue: No ]
    The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible

  • Change From Baseline in Forced Vital Capacity (FVC) [ Time Frame: Baseline,24 hours (hrs) post-dose ] [ Designated as safety issue: No ]
    The FVC is the maximal volume of air that can be exhaled from full inhalation by exhaling as forcefully and rapidly as possible

  • Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75) [ Time Frame: Baseline, 12 hours (hrs) post-dose ] [ Designated as safety issue: No ]
    The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity

  • Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75) [ Time Frame: Baseline, 24 hours (hrs) post-dose ] [ Designated as safety issue: No ]
    The FEF25-75 is the forced expiratory flow between 25 and 75% of vital capacity


Other Outcome Measures:
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) [ Time Frame: Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. ] [ Designated as safety issue: No ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period. ] [ Designated as safety issue: No ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: 14 and 24 hours following dosing in each period. ] [ Designated as safety issue: No ]
    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).


Enrollment: 15
Study Start Date: July 2008
Study Completion Date: July 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04191834 30mg Drug: PF-04191834
30mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets.
Experimental: PF-04191834 100mg Drug: PF-04191834
100mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets, single dose.
Experimental: PF-04191834 2000mg 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.
Placebo Comparator: placebo Drug: Placebo
2 x placebo tablets + placebo oral dispersion, single dose.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723021

Locations
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21225
United States, Massachusetts
Pfizer Investigational Site
North Dartmouth, Massachusetts, United States, 02747
United States, Michigan
Pfizer Investigational Site
Kalamazoo, Michigan, United States, 49007
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00723021     History of Changes
Other Study ID Numbers: B0041002
Study First Received: July 24, 2008
Results First Received: December 27, 2012
Last Updated: December 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Bronchodilator

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Zileuton
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Enzyme Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Lipoxygenase Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 23, 2014