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

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ClinicalTrials.gov Identifier: NCT01364519
Recruitment Status : Completed
First Posted : June 2, 2011
Last Update Posted : February 13, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Fluticasone Propionate Drug: Placebo for Fluticasone Propionate Phase 1

Detailed Description:
Methodology Validation

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Study Start Date : July 2011
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Sputum Neutrophil (%) [ Time Frame: 6 hours post LPS challenge ]

Secondary Outcome Measures :
  1. Sputum Inflammatory cytokines (IL-6, MCP-1 and MIP1beta) [ Time Frame: 6 hours post LPS challenge ]
  2. Blood Inflammatory Cytokines (IL-6, MCP-1, fibrinogen, CC16, CRP and MIP1beta) [ Time Frame: 1, 4 and 6 hours post LPS challenge ]
  3. Sputum cells (macrophages and total cell count) [ Time Frame: 6 hours post LPS challenge ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01364519     History of Changes
Other Study ID Numbers: A9011082
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: February 13, 2012
Last Verified: February 2012

Keywords provided by Pfizer:
COPD

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