Study of Biomarkers of Airway Inflammation (0000-128)

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00869596
First received: March 25, 2009
Last updated: April 17, 2013
Last verified: April 2013

March 25, 2009
April 17, 2013
March 2009
September 2009   (final data collection date for primary outcome measure)
Sputum percent neutrophils [ Time Frame: 6 hours following inhaled LPS challenge ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00869596 on ClinicalTrials.gov Archive Site
  • Sputum absolute neutrophils (per mL) [ Time Frame: 6 hours following inhaled LPS challenge ] [ Designated as safety issue: No ]
  • Sputum levels of IL1beta and IL8 [ Time Frame: 6 hours following inhaled LPS challenge ] [ Designated as safety issue: No ]
  • Sputum mRNA expression levels of CD14 and IL1beta [ Time Frame: 6 hours following inhaled LPS challenge ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Biomarkers of Airway Inflammation (0000-128)
A Randomized Clinical Trial to Assess the Effects of Inhaled Fluticasone on Sputum Neutrophils After Low-dose Inhaled Endotoxin Challenge in Healthy Subjects

This study will evaluate the effects of inhaled fluticasone on cell counts and inflammatory mediators measured in sputum of healthy volunteers following exposure to inhaled lipopolysaccharide.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Airway Inflammation
  • Drug: fluticasone propionate
    Single dose of fluticasone 440 mcg (2 x 220 mcg) or 1980 mcg (9 x 220 mcg) by metered dose inhaler in two of three treatment periods
  • Drug: Comparator: Placebo to fluticasone
    Single dose of placebo to fluticasone (9 x 0 mcg) by metered dose inhaler in one of three treatment periods
  • Drug: Comparator: Lipopolysaccharide (LPS)
    20,000 EU LPS by inhalation 1 hour postdose of fluticasone or placebo in each of three treatment periods
  • Drug: Comparator: albuterol
    Albuterol two 100 mcg inhalations by metered dose inhaler prior to sputum induction at screening, twice during each of the three treatment periods, and at the post-study follow up visit.
  • Placebo Comparator: 1
    Placebo
    Interventions:
    • Drug: Comparator: Placebo to fluticasone
    • Drug: Comparator: Lipopolysaccharide (LPS)
    • Drug: Comparator: albuterol
  • Active Comparator: 2
    Fluticasone 440 mcg
    Interventions:
    • Drug: fluticasone propionate
    • Drug: Comparator: Lipopolysaccharide (LPS)
    • Drug: Comparator: albuterol
  • Active Comparator: 3
    Fluticasone 1980 mcg
    Interventions:
    • Drug: fluticasone propionate
    • Drug: Comparator: Lipopolysaccharide (LPS)
    • Drug: Comparator: albuterol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female subjects who can have children must have a negative pregnancy test at screening and agree to use two methods of birth control throughout the study
  • Male subjects with female partner(s) who can have children agree to use an acceptable method of birth control throughout the study
  • Subject is a nonsmoker
  • Subject is in generally good health
  • Subject is willing to comply with the diet, alcohol, and caffeine study restrictions

Exclusion Criteria:

  • Subject is a nursing mother
  • Subject has taken oral corticosteroids within 8 weeks or inhaled/nasal corticosteroids within 4 weeks of screening
  • Subject has nasal polyps, recent nasal surgery, or an ongoing upper or lower respiratory tract infection
  • Subject has a recent history of allergic rhinitis at screening
  • Subject has any respiratory disease at screening
  • Subject has daily phlegm or a chronic cough
  • Subject is unable to refrain from the use of any prescription or non-prescription drugs or herbal remedies during the study
  • Subject consumes excessive amounts of alcohol or caffeine
  • Subject has had major surgery, or donated or lost 1 unit of blood within 4 weeks of screening
  • Subject has a history of stroke, seizures, or major neurological disorders
  • Subject regularly uses illicit drugs or has a history of drug/alcohol abuse
  • Subject received a vaccination within 3 weeks of screening
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00869596
2009_565, 128
No
Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
April 2013

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