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

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

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Brief Summary

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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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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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SB681323

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No