A Study To Determine Effects Of Fluticasone Propionate On Sputum Neutrophils After Inhaled Lipopolysaccharide Challenge In Volunteers

NCT ID: NCT01364519

Last Updated: 2012-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-01-31

Brief Summary

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Study to assess effect of Fluticasone Propionate on acute lung inflammation following inhaled lipopolysaccharide (LPS) challenge. Study will be conducted in healthy volunteers. Assessment of inflammation will be via sputum induction.

Detailed Description

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Methodology Validation

Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Fluticasone Propionate

Intervention Type DRUG

Dry powder for inhalation, Single Dose, 500mcg

Arm 2

Group Type PLACEBO_COMPARATOR

Placebo for Fluticasone Propionate

Intervention Type DRUG

Dry powder for inhalation, Single Dose, placebo

Interventions

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Fluticasone Propionate

Dry powder for inhalation, Single Dose, 500mcg

Intervention Type DRUG

Placebo for Fluticasone Propionate

Dry powder for inhalation, Single Dose, placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers
* Normoresponsive airways - histamine PC20\>16mg/mL
* Able to complete sputum induction successfully

Exclusion Criteria

* Non (or ex) smokers
* No LPS challenge in previous 4 weeks
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Manchester, Greater Manchester, United Kingdom

Site Status

Pfizer Investigational Site

London, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

Other Identifiers

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A9011082

Identifier Type: -

Identifier Source: org_study_id

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