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NCT01364519 Clinical Trial

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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:
A Randomized, Double-Blind (3rd Party Open), Placebo-Controlled, 2-Way Crossover Study To Determine The Effects Of A Single Inhaled Dose Of 500 MCG Fluticasone Propionate On Induced Sputum Neutrophils Following Inhaled Lipopolysaccharide (LPS) Challenge In Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01364519
Other study ID # A9011082
Secondary ID
Status Completed
Phase Phase 1
First received May 31, 2011
Last updated February 10, 2012
Start date July 2011
Est. completion date January 2012

Study information
Verified date February 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.

Description:

Methodology Validation

Recruitment information / eligibility
Status Completed
Enrollment 17
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

Intervention

Drug:
• Fluticasone Propionate
Dry powder for inhalation, Single Dose, 500mcg
• Placebo for Fluticasone Propionate
Dry powder for inhalation, Single Dose, placebo

Locations
Country Name City State
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site Manchester Greater Manchester

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sputum Neutrophil (%) 6 hours post LPS challenge No
Secondary Sputum Inflammatory cytokines (IL-6, MCP-1 and MIP1beta) 6 hours post LPS challenge No
Secondary Blood Inflammatory Cytokines (IL-6, MCP-1, fibrinogen, CC16, CRP and MIP1beta) 1, 4 and 6 hours post LPS challenge No
Secondary Sputum cells (macrophages and total cell count) 6 hours post LPS challenge No
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