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

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

Tracking Information

• First Submitted Date: May 31, 2011
• First Posted Date: June 2, 2011
• Last Update Posted Date: February 13, 2012
• Study Start Date: July 2011
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 31, 2011): Sputum Neutrophil (%) [ Time Frame: 6 hours post LPS challenge ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 31, 2011)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study To Determine Effects Of Fluticasone Propionate On Sputum Neutrophils After Inhaled Lipopolysaccharide Challenge In Volunteers
• 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
• 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 Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator)
• Condition: Pulmonary Disease, Chronic Obstructive

Intervention

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

Study Arms

• Experimental: Arm 1
  Intervention: Drug: Fluticasone Propionate
• Placebo Comparator: Arm 2
  Intervention: Drug: Placebo for Fluticasone Propionate

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 10, 2012): 17
• Original Estimated Enrollment (submitted: May 31, 2011): 18
• Actual Study Completion Date: January 2012
• Actual Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01364519
• Other Study ID Numbers: A9011082
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: February 2012