Study of Biomarkers of Airway Inflammation - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00869596

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 I

Drug Information available for: Albuterol Levalbuterol hydrochloride Albuterol sulfate Fluticasone propionate Fluticasone Levalbuterol tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study
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

Further study details as provided by Merck:

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 ]

Estimated Enrollment:	24
Study Start Date:	March 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator 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.
2: Active Comparator 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.
3: Active Comparator 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

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

Contacts

Contact: Toll Free Number

1-888-577-8839

Locations

United States, Pennsylvania
Call for Information	Recruiting
Philadelphia, Pennsylvania, United States, 19107-5244

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2009_565, 128
Study First Received:	March 25, 2009
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00869596 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Sputum inflammatory biomarkers

Study placed in the following topic categories:

Anti-Inflammatory Agents
Neurotransmitter Agents
Adrenergic Agents
Adrenergic beta-Agonists
Albuterol
Anti-Asthmatic Agents
Healthy

Anti-Allergic Agents
Adrenergic Agonists
Inflammation
Fluticasone
Peripheral Nervous System Agents
Bronchodilator Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic beta-Agonists
Albuterol
Physiological Effects of Drugs
Anti-Asthmatic Agents
Anti-Allergic Agents
Reproductive Control Agents

Adrenergic Agonists
Pharmacologic Actions
Inflammation
Pathologic Processes
Tocolytic Agents
Autonomic Agents
Therapeutic Uses
Fluticasone
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on May 07, 2009