A Dose Range-Finding, Study of the Effects of SCH 527123 in Subjects With Moderate to Severe COPD
- Conditions
- -J449 Chronic obstructive pulmonary disease, unspecifiedChronic obstructive pulmonary disease, unspecifiedJ449
- Registration Number
- PER-040-09
- Lead Sponsor
- SCHERING PLOUGH RESEARCH INSTITUTE,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 20
• A subject must be >40 to =75 years of age, of either sex, and of any race.
• A subject must have a diagnosis of COPD based on the American Thoracic Society/European Respiratory Society (ATS/ERS)/Global Initiative for Chronic Obstructive Lung Disease (GOLD) current guidelines, or have had symptoms consistent with COPD for =2 years prior to the baseline visit (Visit 2, Day 1).
• A subject must have clinically stable COPD, indicated by no exacerbation and no change in COPD treatment within 6 weeks before Screening and no such change or exacerbation between Screening and Randomization.
• A subject must have a history of sputum production most days of the week within the last 3 months prior to Screening.
• At Screening, in subjects at sites performing sputum induction, post-bronchodilator FEV1 must be =1000 mL.
• At Screening, a subject’s post-bronchodilator FEV1 must be =30% to =70% of the predicted value.
• At Screening, a subject’s ratio of post-bronchodilator FEV1 to forced vital capacity (FVC) must be =70%.
• A subject must be either an ex-smoker with at least 6 months of smoking cessation, or a current smoker, and must have a smoking history of =10 pack-years (ie, 10 pack-year history is equal to smoking 1 pack of cigarettes per day for 10 years or 2 packs per day for 5 years).
• Subjects will be counseled on the risks of smoking and available smoking cessation programs prior to enrollment.
• If a subject had used inhaled corticosteroids (ICS) during the 6 weeks prior to Screening, the subject must have kept to a stable, low or medium daily dosage of ICS, alone or in combination with a long-acting ß-agonist (LABA) or a long-acting muscarinic agonist (LAMA), within the 6 weeks prior to Screening and between Screening and Randomization, and must agree to continue at this dosage during the first 26 weeks (6 months) of the Treatment Period unless directed by the investigator. A low or medium daily ICS dosage is defined in the protocol.
• A female subject of child-bearing potential must agree to use a medically acceptable, highly effective method of birth control (ie, failure rate =1% per year when used consistently and correctly) prior to Screening, and agree to continue using it while in the study (Screening and Treatment Periods) if she is heterosexually active. Medically acceptable, highly effective forms of birth control are hormonal implants, oral contraceptives, hormonal patches, medically acceptable prescribed intrauterine devices (IUDs), and monogamous relationship with a male partner who has had a vasectomy. A female subject who is not of childbearing potential must have a medical record of being surgically sterile (eg, hysterectomy, tubal ligation), or be postmenopausal. Absence of menses for at least 1 year will indicate that a female subject is postmenopausal. A female subject should be encouraged to continue using a highly effective method of birth control 30 days following the end of treatment.
• A female subject of child-bearing potential who is not currently sexually active must agree to use a highly effective method of contraception should she become heterosexually active while participating in the study.
• A heterosexually active male subject must agree to use an adequate form of contraception for the duration of the study and agree to have sexual relations only with those women using a highly effective birth control method. A highly effective method of birth control
• Subject who has been diagnosed with asthma or other clinically relevant lung disease (other than COPD) that, in the opinion of the investigator, precludes the subject from participating in the study (eg, sarcoidosis, tuberculosis, pulmonary fibrosis, severe bronchiectasis, or lung cancer).
• Subject with clinically significant chest X-ray or computed tomography (CT) findings (eg, mass) inconsistent with stable COPD.
• Subject who has undergone lobectomy, pneumonectomy, lung volume reduction (including bronchoscopic lung volume reduction) or any lung surgery other than biopsy.
• Subject who has had a respiratory tract infection within 6 weeks prior to the Screening Visit (Visit 1) and/or between Visit 1 and Visit 2 (Baseline/Randomization Visit).
• Subject with acute, non-respiratory infection(s) at Screening should be excluded until resolution of the infection(s), as determined by the investigator. (The investigator should carefully look for signs and symptoms of any infections by taking a detailed history and physical exam.)
• Subject with >20% and =200 mL improvement at Screening in post bronchodilator FEV1.
• Subject in need of supplemental oxygen therapy for >12 hours per day.
• Subject who is breast-feeding, pregnant, or intends to become pregnant during the study.
• Subjects who decide to discontinue smoking before Randomization are ineligible to participate. Subjects will be counseled on the risks of smoking and available smoking cessation programs prior to enrollment. However, once enrolled, if a subject elects to discontinue smoking, or reduces cigarette consumption, he/she will be allowed to complete the study.
• Subject who is using medication that may interfere with the effect of the study medication (including but not limited to those treatments in Table 4 in the protocol, Medications Prohibited During the Study), or who has a clinically relevant medical condition that may interfere with the study procedures or evaluation, or any condition that is determined by the principal investigator to be significant. Specific examples include (but are not limited to): any history of significant cardiac disease, unstable or severe peripheral artery disease, hematologic or neurologic disease, stroke, hepatitis, abnormal renal or hepatic function tests, severe rheumatoid arthritis, known human immunodeficiency virus (HIV) diagnosis, chronic infections, significant prolongation of corrected QT (ie, QT adjusted for heart rate by Fridericia [QTcF] or Bazett [QTcB] method) >500 msec, uncontrolled or newly diagnosed (within 2 months of study entry) diabetes, insulin-dependent diabetes mellitus, or known alpha-1 antitrypsin deficiency.
• Subject with an ANC of <3 x 10^9/L at the Visit 1 (Screening Visit).
• Subject who has received any treatment listed in the protocol, Table 2 in the protocol, more recently than the indicated washout period prior to Screening.
• Subject who is part of the staff personnel directly involved with this study.
• Subject who is a family member of the investigational study staff.
• Subject who is currently using illicit drugs or abusing alcohol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:FEV1, as measured in liters by spirometry, is the amount of air expired in 1 second. Participants were assessed for post-bronchodilator FEV1 30 minutes after bronchodilator administration (4 puffs of albuterol/salbutamol or equivalent separated by 30-second intervals) (reversibility test) at Baseline and Week 26.<br><br>Measure:Change From Baseline in Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (Period 1)<br>Timepoints:Baseline and Week 26<br>;<br>Outcome name:The percentage of participants who experienced an AE related to an ANC of less than 1.5x10^9 cells/L at one or more visits during the first 26 weeks, the first 52 weeks and the first 104 weeks was to be calculated.<br><br>Measure:Percentage of Participants With an Adverse Event (AE) Related to a Blood Absolute Neutrophil Count (ANC) of Less Than 1.5x10^9 Cells/L<br>Timepoints:Up to 104 weeks<br>
- Secondary Outcome Measures
Name Time Method