NCT01364519

Brief Summary

Study to assess effect of Fluticasone Propionate on acute lung inflammation following inhaled lipopolysaccharide (LPS) challenge. Study will be conducted in healthy volunteers. Assessment of inflammation will be via sputum induction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_1

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

May 31, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
29 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

February 13, 2012

Status Verified

February 1, 2012

Enrollment Period

6 months

First QC Date

May 31, 2011

Last Update Submit

February 10, 2012

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

  • Sputum Neutrophil (%)

    6 hours post LPS challenge

Secondary Outcomes (3)

  • Sputum Inflammatory cytokines (IL-6, MCP-1 and MIP1beta)

    6 hours post LPS challenge

  • Blood Inflammatory Cytokines (IL-6, MCP-1, fibrinogen, CC16, CRP and MIP1beta)

    1, 4 and 6 hours post LPS challenge

  • Sputum cells (macrophages and total cell count)

    6 hours post LPS challenge

Study Arms (2)

Arm 1

EXPERIMENTAL
Drug: Fluticasone Propionate

Arm 2

PLACEBO COMPARATOR
Drug: Placebo for Fluticasone Propionate

Interventions

Fluticasone PropionateDRUG

Dry powder for inhalation, Single Dose, 500mcg

Arm 1
Placebo for Fluticasone PropionateDRUG

Dry powder for inhalation, Single Dose, placebo

Arm 2

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy volunteers
  • Normoresponsive airways - histamine PC20\>16mg/mL
  • Able to complete sputum induction successfully

You may not qualify if:

  • Non (or ex) smokers
  • No LPS challenge in previous 4 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pfizer Investigational Site

Manchester, Greater Manchester, M23 9QZ, United Kingdom

Location

Pfizer Investigational Site

London, SE1 1YR, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 2, 2011

Study Start

July 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 13, 2012

Record last verified: 2012-02

Locations

GB(2)