COPDPhase 2NCT00219648
Two-Stage Study to Assess the Efficacy and Safety of 12 Weeks of Treatment With PEP03 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing PEP03 in people with COPD, run by PharmaEngine at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- PEP03
- How many people
- Not given
- Where
- 1 siteTaiwan
- Study dates
- Sep 2004to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taipei
Han-Pin Kuo, MD, PH D, 03-328-1200 ext. 8467, q8828@ms11.hinet.net
Han-Pin Kuo, MD,PHD
About this study
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)
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
- Conditions
- COPD
- Being tested
- PEP03
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP03Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- PharmaEngine
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219648
- Sponsor's protocol ID
- PEP0301
- Status last verified
- Sep 2005
- First submitted
- 20 Sep 2005
- Last updated
- 22 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00219648
- Acronym / sponsor ID
- PEP0301
- Conditions
- COPD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- PharmaEngineIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEP03 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEP03 in people with COPD, run by PharmaEngine at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2005.