Study of Biomarkers of Airway Inflammation (0000-128)

Airway Inflammation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00869596
• Other study ID #: 0000-128
• Secondary ID: 2009_565
• Status: Completed
• Phase: Phase 1
• First received: March 25, 2009
• Last updated: July 22, 2015
• Start date: March 2009
• Est. completion date: September 2009

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Airway Inflammation
• Inflammation

Intervention

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
• Comparator: Placebo to fluticasone
Single dose of placebo to fluticasone (9 x 0 mcg) by metered dose inhaler in one of three treatment periods
• Comparator: Lipopolysaccharide (LPS)
20,000 EU LPS by inhalation 1 hour postdose of fluticasone or placebo in each of three treatment periods
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sputum percent neutrophils		6 hours following inhaled LPS challenge	No
Secondary	Sputum absolute neutrophils (per mL)		6 hours following inhaled LPS challenge	No
Secondary	Sputum levels of IL1beta and IL8		6 hours following inhaled LPS challenge	No
Secondary	Sputum mRNA expression levels of CD14 and IL1beta		6 hours following inhaled LPS challenge	No