NCT00877539

Brief Summary

PF-03526299, 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
29

participants targeted

Target at P25-P50 for phase_1 asthma

Timeline
Completed

Started Jun 2009

Typical duration for phase_1 asthma

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

April 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

September 28, 2010

Status Verified

September 1, 2010

Enrollment Period

6 months

First QC Date

April 6, 2009

Last Update Submit

September 27, 2010

Conditions

Asthma

Keywords

Asthma Allergen Challenge

Outcome Measures

Primary Outcomes (1)

  • Spirometry pre- and post- bronchial allergen challenge

    2 months

Secondary Outcomes (5)

  • Laboratory safety tests

    2 months

  • 12-lead ECGs

    2 months

  • Adverse Event reporting

    2 months

  • Blood samples for pharmacokinetic measurement

    2 months

  • Sputum for pharmacodynamic measurement

    2 months

Study Arms (3)

PF-03526299

EXPERIMENTAL
Drug: PF-03526299

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Fluticasone propionate

ACTIVE COMPARATOR
Drug: Fluticasone propionate

Interventions

PF-03526299DRUG

Inhaled, two doses 4 hours apart

PF-03526299
PlaceboDRUG

Inhaled, two doses 4 hours apart

Placebo
Fluticasone propionateDRUG

Inhaled

Fluticasone propionate

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 (2)

Pfizer Investigational Site

London, SE1 1YR, United Kingdom

Location

Pfizer Investigational Site

Manchester, M23 9QZ, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

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

April 6, 2009

First Posted

April 7, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2009

Study Completion

July 1, 2010

Last Updated

September 28, 2010

Record last verified: 2010-09

Locations

GB(2)