Two-Stage Study to Assess the Efficacy and Safety of 12 Weeks of Treatment With PEP03 in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00219648
Recruitment Status : Unknown
Verified September 2005 by PharmaEngine.
Recruitment status was:  Recruiting
First Posted : September 22, 2005
Last Update Posted : September 22, 2005
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Brief Summary:

PEP03 is a new chemical entity developed as a highly selective, potent, and orally active 5-LO inhibitor. PEP03 exerts its action by blocking the generation of both cysteinyl LTs and LTB4. These LTs have been associated with the inflammatory response in the lung and with the clinical sequelae, including bronchospasm. Preclinical pharmacological in- vitro, ex-vivo and in-vivo testing indicates that PEP03 has multiple beneficial actions including prevention of bronchoconstriction, and reduction of vascular leakage, cellular infiltration, and bronchial hyperresponsiveness.

Clinical studies in asthmatic patients indicate that PEP03 improved FEV1 and other secondary endpoints, such as morning and evening peak flow, daytime and nighttime symptoms score, beta-agonist use, physician’s and patient’s global impression of change. Since leukotrienes have been suggested to be involved in the pathophysiology of COPD, this study is designed to explore the clinical utility of PEP03 for the treatment of moderate COPD.6; 7; 8; 9

Condition or disease Intervention/treatment Phase
COPD Drug: PEP03 Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose- Finding, Two-Stage Study to Assess the Efficacy and Safety of 12 Weeks of Treatment With PEP03 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study Start Date : September 2004

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 1. Subjects have to be > 40 years of age. 2. Subjects must have baseline 40% ≦ FEV1(pre-bronchodilator) ≦ 70% of predicted value, and FEV1/FVC < 70% at Visits 1 and 2.

    3. Subjects must have at least one episode of COPD-related symptoms (e.g. cough, sputum production, shortness of breath) within 2 months prior to screening.

    4. Subjects must have a < 12% increase in FEV1 after a fixed dose of bronchodilator (200 g inhaled salbutamol).

    5. Subjects have a history of > 10 pack years of smoking (1 pack year = 20 cigarettes smoked per day for 1 year or equivalent).

    6. Subjects of childbearing potential must use adequate birth control measures and must have a negative serum pregnancy test prior to study entry.

    7. Subjects have to be able to adhere to the study visit schedule and other protocol requirements.

    8. Subjects must have the ability to use peak flow meter correctly and record patient diary cards 9. Subjects must provide signed, written informed consent prior to participation in the study.

Exclusion Criteria:

  • 1. Subjects have asthma, allergic rhinitis or atopy as main component of their obstructive airway disease.

    2. Subjects are being treated with long term oxygen therapy, requiring supplemental oxygen more often than on an occasional/as need basis or requiring nocturnal positive pressure for sleep apnea.

    3. Subjects have a history of severe right sided heart failure or cor pulmonale.

    4. Subjects have had a serious infection (e.g. hepatitis, pneumonia or pyelonephritis) within the previous 3 months.

    5. Subjects have airway obstruction due to diseases with known etiology or specific pathology, such as cystic fibrosis, or bronchiectasis.

    6. Subjects with lung cancer, sarcoidosis, tuberculosis, or lung fibrosis. 7. Subjects with a history of drug or alcohol abuse. 8. Subjects have used investigational drugs within 1 month prior to screening or within 5 half-lives of the investigational agent, whichever is longer.

    9. Subjects are currently treated with cromolyn sodium or nedocromil, long-acting theophylline, leukotriene modifiers, oral or inhaled corticosteroids, long acting β2-agonists, or long-acting anticholinergics.

    10. Subjects with liver enzymes (AST, ALT, bilirubin) > 3 X upper limit of normal range.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00219648

Chang Gung Memorial Hospital Recruiting
Taipei, Taiwan
Contact: Han-Pin Kuo, MD, PH D    03-328-1200 ext 8467   
Principal Investigator: Han-Pin Kuo, MD,PHD         
Sponsors and Collaborators
PharmaEngine Identifier: NCT00219648     History of Changes
Other Study ID Numbers: PEP0301
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 22, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases