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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01364519
First received: May 31, 2011
Last updated: February 10, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
 Drug: Fluticasone Propionate
Drug: Placebo for Fluticasone Propionate
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Sputum Neutrophil (%) [ Time Frame: 6 hours post LPS challenge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sputum Inflammatory cytokines (IL-6, MCP-1 and MIP1beta) [ Time Frame: 6 hours post LPS challenge ] [ Designated as safety issue: No ]
  • Blood Inflammatory Cytokines (IL-6, MCP-1, fibrinogen, CC16, CRP and MIP1beta) [ Time Frame: 1, 4 and 6 hours post LPS challenge ] [ Designated as safety issue: No ]
  • Sputum cells (macrophages and total cell count) [ Time Frame: 6 hours post LPS challenge ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: July 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Fluticasone Propionate
Dry powder for inhalation, Single Dose, 500mcg
Placebo Comparator: Arm 2 Drug: Placebo for Fluticasone Propionate
Dry powder for inhalation, Single Dose, placebo

Detailed Description:

Methodology Validation

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01364519

Locations
United Kingdom
Pfizer Investigational Site
Manchester, Greater Manchester, United Kingdom, M23 9QZ
Pfizer Investigational Site
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01364519     History of Changes
Other Study ID Numbers: A9011082
Study First Received: May 31, 2011
Last Updated: February 10, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Pfizer:
COPD

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases, Obstructive
Fluticasone
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 21, 2013