Study of Biomarkers of Airway Inflammation (0000-128)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00869596
First received: March 25, 2009
Last updated: August 1, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Airway Inflammation
Drug: fluticasone propionate
Drug: Comparator: Placebo to fluticasone
Drug: Comparator: Lipopolysaccharide (LPS)
Drug: Comparator: albuterol
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: A Randomized Clinical Trial to Assess the Effects of Inhaled Fluticasone on Sputum Neutrophils After Low-dose Inhaled Endotoxin Challenge in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Sputum percent neutrophils [ Time Frame: 6 hours following inhaled LPS challenge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 22
Study Start Date: March 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
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.
Active Comparator: 2
Fluticasone 440 mcg
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: 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.
Active Comparator: 3
Fluticasone 1980 mcg
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: 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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00869596

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00869596     History of Changes
Other Study ID Numbers: 0000-128, 2009_565
Study First Received: March 25, 2009
Last Updated: August 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Sputum inflammatory biomarkers

Additional relevant MeSH terms:
Inflammation
Pathologic Processes
Fluticasone
Albuterol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014