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fluticasone propionate

Phase 1

Airway Inflammation | Small molecule | Respiratory |Merck & Company, Inc.|Last Updated: Jul 23, 2015

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

fluticasone propionate · 1 trial · 1 indication

Phase 1 1
NCT00869596Study of Biomarkers of Airway Inflammation (0000-128)Airway Inflammation
COMPLETED22 Analytics
PHASE1COMPLETED
Study of Biomarkers of Airway Inflammation (0000-128)
Airway InflammationUnlock trial analytics

Study Endpoints

Primary Endpoints

Sputum percent neutrophils
6 hours following inhaled LPS challenge

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
1PLACEBO_COMPARATORPlacebo
2ACTIVE_COMPARATORFluticasone 440 mcg
3ACTIVE_COMPARATORFluticasone 1980 mcg

Interventions

NameTypeDescription
fluticasone propionateDRUGSingle 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 fluticasoneDRUGSingle dose of placebo to fluticasone (9 x 0 mcg) by metered dose inhaler in one of three treatment periods
Comparator: Lipopolysaccharide (LPS)DRUG20,000 EU LPS by inhalation 1 hour postdose of fluticasone or placebo in each of three treatment periods
Comparator: albuterolDRUGAlbuterol 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.
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes

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 ...

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Frequently asked questions about fluticasone propionate

What is fluticasone propionate used for?

Fluticasone propionate is a small molecule being studied for airway inflammation in the respiratory therapeutic area. It is currently in Phase 1 clinical development as an investigational therapy. The drug is being evaluated for its effects on biomarkers of airway inflammation.

Who makes fluticasone propionate?

Fluticasone propionate is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical research on this small molecule for the treatment of airway inflammation.

What phase is fluticasone propionate in?

Fluticasone propionate is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed to evaluate the drug in healthy volunteers.

What clinical trials is fluticasone propionate in?

Fluticasone propionate has one completed clinical trial, NCT00869596, titled "Study of Biomarkers of Airway Inflammation (0000-128)." This Phase 1 study enrolled 22 participants, was randomized, double-blind, and placebo-controlled, and included healthy volunteers aged 18 years and older.

How does fluticasone propionate work?

Fluticasone propionate is a small molecule being investigated for its effects on airway inflammation. The specific molecular target has not been disclosed in available information, so its mechanism of action is not fully characterized in public data.