A Study To Determine Effects Of Fluticasone Propionate On Sputum Neutrophils After Inhaled Lipopolysaccharide Challenge In Volunteers

Phase 1

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Fluticasone Propionate; Drug: Placebo for Fluticasone Propionate

• Registration Number: NCT01364519
• Lead Sponsor: Pfizer

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.

Detailed Description

Methodology Validation

Study Timeline

• Study First Submitted: 2011-05-31
• Study First Submitted QC: 2011-05-31
• Study First Posted: 2011-06-02
• Study Start: 2011-07
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-10
• Last Update Posted: 2012-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Fluticasone Propionate	-
Arm 2	Placebo for Fluticasone Propionate	-

Primary Outcome Measures

Name	Time	Method
Sputum Neutrophil (%)	6 hours post LPS challenge

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 London, United Kingdom