NCT00856687

Brief Summary

PF-03893787, a novel anti-inflammatory agent should attenuate the effect of a bronchial allergen challenge on lung function and hence provide proof of mechanism for this agent.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1 asthma

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

March 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 22, 2010

Status Verified

January 1, 2010

Enrollment Period

8 months

First QC Date

March 5, 2009

Last Update Submit

January 21, 2010

Conditions

Asthma

Keywords

Asthma Allergen Challenge

Outcome Measures

Primary Outcomes (1)

  • Spirometry pre- and post- bronchial allergen challenge

    2 months

Secondary Outcomes (4)

  • Laboratory safety tests

    2 months

  • 12-lead ECGs

    2 months

  • Adverse Event reporting

    2 months

  • Blood samples for pharmacokinetic measurement

    2 months

Study Arms (3)

PF-03893787

EXPERIMENTAL
Drug: PF-03893787

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Montelukast

ACTIVE COMPARATOR
Drug: Montelukast

Interventions

PF-03893787DRUG

Oral, two doses 12 hours apart

PF-03893787
PlaceboDRUG

Oral, two doses 12 hours apart

Placebo
MontelukastDRUG

Oral, two doses 12 hours apart

Montelukast

Eligibility Criteria

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

You may qualify if:

  • Males and females 18-60 years.
  • Mild asthma
  • Atopic to allergens

You may not qualify if:

  • Unstable asthma.
  • Smokers or recent ex-smokers
  • Recent allergen challenge

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Harrow, Middlesex, HA1 3UJ, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

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

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 5, 2009

First Posted

March 6, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

January 22, 2010

Record last verified: 2010-01

Locations

GB(1)