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Evaluate the Effects of the Drug (SB-656933-AAA) on the Body After a Single Dose in Subjects Who Have Inhaled Ozone.

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: October 29, 2007
Last updated: October 14, 2010
Last verified: October 2010
A study to evaluate the effect of SB-656933-AAA on the body after a single dose in subjects who have been challenged with ozone.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD) Cystic Fibrosis Drug: SB-656933-AAA Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo Controlled, 3-way Crossover Study to Evaluate the Pharmacodynamics of SB-656933-AAA Following Single Doses in Healthy Adult Subjects Undergoing Ozone Challenge.

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • To assess the effect of a single dose of SB-656933-AAA on ozone-induced inflammation in healthy subjects. Total number of neutrophils in sputum 6 hours after inhaling ozone. [ Time Frame: 6 hours after inhaling ozone ]

Secondary Outcome Measures:
  • Total number of white cells in sputum 6 hours after inhaling ozone. Concentration of protein in sputum. Safety of SB-656933-AAA. [ Time Frame: 6 hours after inhaling ozone ]

Estimated Enrollment: 24
Study Start Date: October 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy subjects between 18-50 years.
  • Females should be of non-child bearing potential.
  • Non-smoking for at least 12 months.
  • Normal lung function.
  • Subjects should be able to produce acceptable sputum samples.

Exclusion Criteria:

  • Any serious medical condition.
  • Hepatitis B or C and/or HIV positive.
  • Currently on regular medication except paracetamol.
  • Body Mass Index <20 or >30.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00551811

GSK Investigational Site
Berlin, Germany, 14050
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Responsible Party: Study Director, GSK Identifier: NCT00551811     History of Changes
Other Study ID Numbers: CR2100597
Study First Received: October 29, 2007
Last Updated: October 14, 2010

Keywords provided by GlaxoSmithKline:
single dose,
ozone challenge

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Cystic Fibrosis
Respiratory Tract Diseases
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases processed this record on June 28, 2017