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Trial record 1 of 1 for:    NCT01364519
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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

Tracking Information
First Submitted Date  ICMJE May 31, 2011
First Posted Date  ICMJE June 2, 2011
Last Update Posted Date February 13, 2012
Study Start Date  ICMJE July 2011
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2011)
Sputum Neutrophil (%) [ Time Frame: 6 hours post LPS challenge ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Determine Effects Of Fluticasone Propionate On Sputum Neutrophils After Inhaled Lipopolysaccharide Challenge In Volunteers
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Pulmonary Disease, Chronic Obstructive
Intervention  ICMJE
  • Drug: Fluticasone Propionate
    Dry powder for inhalation, Single Dose, 500mcg
  • Drug: Placebo for Fluticasone Propionate
    Dry powder for inhalation, Single Dose, placebo
Study Arms  ICMJE
  • Experimental: Arm 1
    Intervention: Drug: Fluticasone Propionate
  • Placebo Comparator: Arm 2
    Intervention: Drug: Placebo for Fluticasone Propionate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2012)
17
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2011)
18
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01364519
Other Study ID Numbers  ICMJE A9011082
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP