CompletedNCT00869596Updated Jul 23, 2015

Study of Biomarkers of Airway Inflammation (0000-128)

A Phase 1 interventional study of fluticasone propionate and Comparator: Placebo to fluticasone in Airway Inflammation, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-23.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Diagnostic

Phase: Phase 1
Study type: Interventional
Enrollment: 22
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: All

Study 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.

Conditions studied

Airway Inflammation

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Inflammation 3,438

Keywords

Sputum inflammatory biomarkers

In context

Inflammation

3,438 studies on the registry are indexed under Inflammation; 629 are open to participants now.

This study's enrollment of 22 is below the median of 50 across 2,436 interventional studies indexed under Inflammation.

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Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,111 studies on the registry; 130 are open to participants now.

Of its 488 completed or terminated interventional studies of FDA-regulated products, 361 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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

Phase: Phase 1
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 22 participants (actual)

Study arms

Placebo comparator
1
Placebo
Drug: Comparator: Placebo to fluticasone · Drug: Comparator: Lipopolysaccharide (LPS) · Drug: Comparator: albuterol
Active comparator
2
Fluticasone 440 mcg
Drug: fluticasone propionate · Drug: Comparator: Lipopolysaccharide (LPS) · Drug: Comparator: albuterol
Active comparator
3
Fluticasone 1980 mcg
Drug: fluticasone propionate · Drug: Comparator: Lipopolysaccharide (LPS) · Drug: Comparator: albuterol

Interventions

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

What researchers measure

Primary outcomes

Sputum percent neutrophils
Time frame: 6 hours following inhaled LPS challenge

Secondary outcomes

Sputum absolute neutrophils (per mL)
Time frame: 6 hours following inhaled LPS challenge
Sputum levels of IL1beta and IL8
Time frame: 6 hours following inhaled LPS challenge
Sputum mRNA expression levels of CD14 and IL1beta
Time frame: 6 hours following inhaled LPS challenge

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00869596
Lead sponsor: Merck Sharp & Dohme LLC
Responsible party: Sponsor
First posted: Mar 26, 2009
Start date: Mar 2009
Primary completion: Sep 2009
Completion: Sep 2009
Last update: Jul 23, 2015

Study contacts

Medical Monitor

study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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