Clinical Trials Logo
  1. Home
  2. Other
  3. NCT00515268
  4. Details
NCT00515268 Clinical Trial

Endotoxin Challenge Study For Healthy Men and Women

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:
A Double Blind, Placebo Controlled, Repeat Dose Study to Compare the Effectiveness of Two Doses of GSK256066 With Placebo in Reducing Lung Inflammation Following Segmental LPS Challenge in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00515268
Other study ID # IPC103711
Secondary ID
Status Completed
Phase Phase 1
First received August 9, 2007
Last updated August 4, 2017
Start date September 27, 2007
Est. completion date April 23, 2008

Study information
Verified date August 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The proposed study will examine the effect of pre-treatment with inhaled GSK256066 using a lung inflammation model induced by bronchoscopic instillation of bacterial endotoxin (lipopolysaccharide, LPS) in healthy volunteers.Data from this study will be used to support GSK256066 dose selection for future studies in COPD patients.

Recruitment information / eligibility
Status Completed
Enrollment 37
Est. completion date April 23, 2008
Est. primary completion date April 23, 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Healthy males and females (contraception restrictions),

- 18-50yrs,

- BMI 19-31kg/m2,

- Non-smokers,

- FEV1 >/= 80% predicted

Exclusion Criteria:

- Abnormal troponin and/or CK MB,

- Participated in any GSK study involving the administration of COA for >/= 21 days.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• GSK256066
GSK256066 will be available as dry powder inhaler with dosing strengths of 12.5, 37.5, 50 micrograms per inhalation.
• Placebo
Subjects will receive placebo inhaler.

Locations
Country Name City State
Germany GSK Investigational Site Hannover Niedersachsen

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Absolute BAL neutrophils at 24 h post LPS exposure The total and differential cell count (absolute and percentage cell counts) in BAL at 24 h post LPS exposure 24 hours
Secondary Vital signs, ECG, FEV1, Serum concentration of protein inflammatory biomarkers, BAL concentrations of protein inflammatory biomarkers BAL concentrations of GSK256066, Day 1,Day 7&DAY 8 Day 1,Day 7&DAY 8
See also
  Status Clinical Trial Phase
Completed NCT05043428 - The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD N/A
Completed NCT00528996 - An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler. Phase 2
Completed NCT03740373 - A Study to Assess the Pulmonary Distribution of Budesonide, Glycopyrronium and Formoterol Fumarate Phase 1
Completed NCT05402020 - Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan
Completed NCT05393245 - Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
Completed NCT04011735 - Re-usable Respimat® Soft MistTM Inhaler Study
Enrolling by invitation NCT03075709 - The Development, Implementation and Evaluation of Clinical Pathways for Chronic Obstructive Pulmonary Disease (COPD) in Saskatchewan
Completed NCT03764163 - Image and Model Based Analysis of Lung Disease Early Phase 1
Completed NCT04085302 - TARA Working Prototype Engagement Evaluation: Feasibility Study N/A
Completed NCT03691324 - Training of Inhalation Technique in Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients - a Pilot Study N/A
Completed NCT02236611 - A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium 62.5 Microgram (mcg) Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Phase 4
Completed NCT00153075 - Flow Rate Effect Respimat Inhaler Versus a Metered Dose Inhaler Using Berodual in Patients With Chronic Obstructive Pulmonary Disease (COPD) Phase 4
Completed NCT01017952 - A Study to Evaluate Annual Rate of Exacerbations and Safety of 3 Dosage Strengths of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT01009463 - A Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Completed NCT04882124 - Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD Phase 2
Completed NCT02853123 - Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients Phase 4
Completed NCT02619357 - Method Validation Study to Explore the Sensitivity of SenseWear Armband Gecko for Measuring Physical Activity in Subjects With Chronic Obstructive Pulmonary Disease (COPD) & Asthma Phase 1
Recruiting NCT05858463 - High Intensity Interval Training and Muscle Adaptations During PR N/A
Not yet recruiting NCT05032898 - Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study Stage II
Completed NCT02837380 - A Phase I Pharmacokinetic Study of Fluticasone Furoate /Umeclidinium Bromide/Vilanterol (100/62.5/25 Microgram [mcg]) After Single and Repeat Dose Administration From a Dry Powder Inhaler in Healthy Chinese Subjects Phase 1

External Links