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Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers | Clinical Trials | Clareo Health

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Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers

Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Way Crossover Study To Determine The Effects Of Single Inhaled Doses Of PF-03715455 (20 Mg) And PH-797804 (30 Mg) On Induced Sputum Neutrophils Following Inhaled Lipopolysaccharide (LPS) Challenge In Healthy Volunteers

NCT01314885•Pfizer

View on ClinicalTrials.gov

Summary

A single dose study with the inhaled anti-inflammatory agent PF-03715455 to establish if it has anti-inflammatory activity following a challenge with LPS. Inhaled LPS invokes an acute inflammatory response in the lung which can be seen in induced sputum. PH-0797804 is an internal control for the study.

Detailed Description

Proof of Mechanism

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male or female (of non-child bearing potential) subjects, aged 18-50 years.
•Subjects whose FEV1 and FVC at screening are both greater than or equal to 80% of their predicted value for age, race, sex and height.
•Subjects who have normoresponsive airways.
•Subjects who are able to successfully complete screening sputum inductions.

Exclusion Criteria

•Subjects who have evidence, on review of pre-study laboratory data and full physical examination, or history of any clinically significant hematological, renal, endocrine, gastrointestinal, dermatological, hepatic, psychiatric, neurologic diseases. Specifically liver function tests and CRP must be within the reference range.
•Subjects with a medical history of asthma symptomatology (ie, wheeze and/or dyspnea at rest).
•Subjects who have experienced a respiratory tract infection within the previous 4 weeks or any other infection within 1 week of dosing

Locations (2)

Pfizer Investigational Site

London, United Kingdom

Pfizer Investigational Site

Manchester, United Kingdom

Key Dates

Start Date

January 1, 2011

Primary Completion Date

December 1, 2011

Completion Date

December 1, 2011

Last Updated

February 2, 2012

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

PF-03715455

DRUG

PH-797804

DRUG

Placebo for PF-03715455

DRUG

Placebo for PH-797804

DRUG

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RECRUITINGNA

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NCT07382258

Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGNA

Mindful-Breath for People With COPD

NCT07195838

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Single Dose Lipopolysaccharide (LPS) Study In Healthy Volunteers

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Clinical Study of Inhaled Nitric Oxide in Patients With Chronic Obstructive Pulmonary Disease

Mindful-Breath for People With COPD

The HELlenic Thoracic Society Initiative for CΟPD and CVD

Magnetic Stimulation of Diaphragm in Chronic Obstructive Pulmonary Disease

COPD Exacerbation Modelling Using Unobtrusive Sensors - the TOLIFE Clinical Study A