Study of Biomarkers of Airway Inflammation (0000-128) - Full Text View

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:

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

U.S. FDA Resources

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 ]

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

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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00869596 History of Changes
Other Study ID Numbers:	2009_565, 128
Study First Received:	March 25, 2009
Last Updated:	April 17, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

Sputum inflammatory biomarkers

Additional relevant MeSH terms:

Inflammation
Pathologic Processes
Albuterol
Fluticasone
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013