NCT00723021

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2 asthma

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
3.6 years until next milestone

Results Posted

Study results publicly available

February 1, 2013

Completed
Last Updated

February 1, 2013

Status Verified

December 1, 2012

Enrollment Period

5 months

First QC Date

July 24, 2008

Results QC Date

December 27, 2012

Last Update Submit

December 27, 2012

Conditions

Asthma

Keywords

Bronchodilator

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Change From Baseline in Forced Vital Capacity (FVC)

    Baseline, 12 hours (hrs) post-dose

  • Change From Baseline in Forced Vital Capacity (FVC)

    Baseline,24 hours (hrs) post-dose

  • Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)

    Baseline, 12 hours (hrs) post-dose

  • Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)

    Baseline, 24 hours (hrs) post-dose

Other Outcomes (5)

  • Area Under the Curve From Time Zero to Last Quantifiable 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.

  • +2 more other outcomes

Study Arms (5)

PF-04191834 30mg

EXPERIMENTAL
Drug: PF-04191834

PF-04191834 100mg

EXPERIMENTAL
Drug: PF-04191834

PF-04191834 2000mg

EXPERIMENTAL
Drug: PF-04191834

zileuton

ACTIVE COMPARATOR
Drug: zileuton

placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PF-04191834DRUG

30mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets.

PF-04191834 30mg
zileutonDRUG

1200mg, 2 x 600mg tablets, single dose + placebo oral dispersion, single dose.

zileuton
PlaceboDRUG

2 x placebo tablets + placebo oral dispersion, single dose.

placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pfizer Investigational Site

Baltimore, Maryland, 21225, United States

Location

Pfizer Investigational Site

North Dartmouth, Massachusetts, 02747, United States

Location

Pfizer Investigational Site

Kalamazoo, Michigan, 49007, United States

Location

Pfizer Investigational Site

Omaha, Nebraska, 68131, United States

Location

Related Links

MeSH Terms

Conditions

Asthma

Interventions

zileuton

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2008

First Posted

July 28, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2008

Study Completion

July 1, 2009

Last Updated

February 1, 2013

Results First Posted

February 1, 2013

Record last verified: 2012-12

Locations

US(4)