NCT00869596

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

March 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

6 months

First QC Date

March 25, 2009

Last Update Submit

July 22, 2015

Conditions

Airway Inflammation

Keywords

Sputum inflammatory biomarkers

Outcome Measures

Primary Outcomes (1)

  • Sputum percent neutrophils

    6 hours following inhaled LPS challenge

Secondary Outcomes (3)

  • Sputum absolute neutrophils (per mL)

    6 hours following inhaled LPS challenge

  • Sputum levels of IL1beta and IL8

    6 hours following inhaled LPS challenge

  • Sputum mRNA expression levels of CD14 and IL1beta

    6 hours following inhaled LPS challenge

Study Arms (3)

1

PLACEBO COMPARATOR

Placebo

Drug: Comparator: Placebo to fluticasoneDrug: Comparator: Lipopolysaccharide (LPS)Drug: Comparator: albuterol

2

ACTIVE COMPARATOR

Fluticasone 440 mcg

Drug: fluticasone propionateDrug: Comparator: Lipopolysaccharide (LPS)Drug: Comparator: albuterol

3

ACTIVE COMPARATOR

Fluticasone 1980 mcg

Drug: fluticasone propionateDrug: Comparator: Lipopolysaccharide (LPS)Drug: Comparator: albuterol

Interventions

fluticasone propionateDRUG

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

23
Comparator: Placebo to fluticasoneDRUG

Single dose of placebo to fluticasone (9 x 0 mcg) by metered dose inhaler in one of three treatment periods

1
Comparator: Lipopolysaccharide (LPS)DRUG

20,000 EU LPS by inhalation 1 hour postdose of fluticasone or placebo in each of three treatment periods

123
Comparator: albuterolDRUG

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.

123

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Fluticasone

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 26, 2009

Study Start

March 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

July 23, 2015

Record last verified: 2015-07