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Completed

NCT Number: NCT00869596

Study of Biomarkers of Airway Inflammation (0000-128)

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.

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Key information

Conditions

Airway Inflammation

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluticasone propionate

Drug

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

Drug

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

Comparator: Lipopolysaccharide (LPS)

Drug

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

Comparator: albuterol

Drug

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.

Primary outcomes

  1. Sputum percent neutrophils

    Time frame: 6 hours following inhaled LPS challenge

Secondary outcomes

  1. Sputum absolute neutrophils (per mL)

    Time frame: 6 hours following inhaled LPS challenge

  2. Sputum levels of IL1beta and IL8

    Time frame: 6 hours following inhaled LPS challenge

  3. Sputum mRNA expression levels of CD14 and IL1beta

    Time frame: 6 hours following inhaled LPS challenge

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized Clinical Trial to Assess the Effects of Inhaled Fluticasone on Sputum Neutrophils After Low-dose Inhaled Endotoxin Challenge in Healthy Subjects

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 26, 2009
Registry last updated
Jul 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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