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OpenTrials
Completed

NCT Number: NCT00144859

Safety And Anti-Inflammatory Effect Of SB681323 In Patients With Chronic Obstructive Pulmonary Disease (COPD)

This is a 28-day, placebo controlled clinical study assessing the safety, tolerability anti-inflammatory effect and pharmacokinetics of SB681323 in patients with COPD (Chronic Obstructive Pulmonary Disease).

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Chronic Obstructive Pulmonary Disease (COPD) Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Aalborg, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Non-childbearing potential.
  • Clinical diagnosis of COPD.
  • Cigarette smoking history of greater than or equal to 10 pack years.
  • Post-bronchodilator FEV1 to FVC ratio (FEV1:FVC) < 0.7
  • Post-bronchodilator FEV1 50% - 80% of predicted normal.
  • Receiving inhaled corticosteroids for a minimum of 6 weeks prior to Screening.
  • Serum CRP concentration greater than 3mg/L.

Exclusion criteria

  • Current diagnosis of asthma.
  • Active tuberculosis, sarcoidosis or bronchiectasis.
  • History of any type of malignancy, rheumatoid arthritis or other conditions associated with chronic inflammation.
  • Clinically significant renal or hepatic disease.
  • History of increased liver function tests, or patients receiving hormone replacement therapy, statins or systemic or topical corticosteroids.

Treatment and study plan

SB681323

Drug

Primary outcomes

  1. Safety and tolerability as assessed by incidence of elevated liver function tests. Serum concentration c-reactive protein (CRP)

Secondary outcomes

  1. Inflammatory markers in blood and sputum Spirometric lung function tests Dyspnoea measured by the TDI Safety assessments Population Pharmacokinetics

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A 28-day, Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Anti-inflammatory Effect and Steady-state Pharmacokinetics of SB-681323 7.5 mg Per Day in Patients With Chronic Obstructive Pulmonary Disease.

Important dates

Study start
2005
First posted
Sep 5, 2005
Registry last updated
Jun 4, 2012

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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