Chronic Obstructive Pulmonary Disease MedDRA version: 8.1 Level: LLT Classification code 10009033 Term: Chronic obstructive pulmonary disease
Conditions
Interventions
Product Name: SCH 527123 monohydrate capsules
Product Code: SCH 527123
Pharmaceutical Form: Capsule*
CAS Number: 862464-58-2
Current Sponsor code: SCH 527123
Other descriptive name: None
Concentration
Sponsors
Schering Plough Research Institute, a division of Schering Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject must have a diagnosis of COPD for at least 2 years based on the American Thoracic Society (ATS) current guidelines: Standards for the Diagnosis and Care of Patients with Chronic Obstructive Pulmonary Disease; 1995 (http://www.thoracic.org/sections/publications/statements/pages/respiratory-disease-adults/copd1-45.html), or symptoms consistent with COPD for at least 2 years. 2. Subject must be >40 up to 75 years of age, of either sex, and of any race. 3. Subject must be current smoker with at least 10 pack-years of smoking history (eg, 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). Subject will be counseled on the risks of smoking and available smoking cessation programs prior to enrollment. Subject who elects to continue to smoke will be eligible for enrollment. Once enrolled, if a subject elects to discontinue smoking, or reduces cigarette consumption, he/she will be allowed to complete the study. 4. Subject must have a history of daily sputum production most days of the week for at least the past 3 months. 5. Post-bronchodilator FEV1 must be at least 800 mL, and at least 40% up to 70% of predicted FEV1. 6. Post-bronchodilator ratio of FEV1 to forced vital capacity (FVC) must be less than or equal to 70%. 7. A female subject of childbearing potential must be using a medically acceptable, highly effective, adequate form of birth control (ie, failure rate =65 years) yes F.1.3.1 Number of subjects for thi
Exclusion criteria
Exclusion criteria: 1. Subject who has been diagnosed with asthma or other clinically relevant lung disease (other than COPD), eg, sarcoidosis, tuberculosis, pulmonary fibrosis, bronchiectasis, or lung cancer. 2. Subject with history of previous lung surgery (eg, lobectomy, pneumonectomy, or lung volume reduction). 3. Subject who has had a lower respiratory tract infection within 4 weeks prior to the Screening Visit. 4. Subject receiving chronic antibiotic therapy. 5. Subject who has had an exacerbation of COPD within the 4 weeks prior to the Screening Visit. 6. Subject with >20% change at Screening in post-bronchodilator FEV1. 7. A subject who is breast-feeding, pregnant, or intends to become pregnant during the study. 8. Subject with clinically relevant medical condition (eg, hematologic, cardiovascular, renal, hepatic, neurologic, or metabolic). 9. Subject who has taken inhaled or systemic steroids within 4 weeks of Visit 1. 10. Subject who has received an investigational drug within the last 30 days. 11. Subject who has received any prohibited treatment listed in more recently than the indicated washout period, prior to (Screening), or who must continue to receive any prohibited treatment. 12. Subject who is part of the staff personnel directly involved with this study. 13. Subject who is a family member of the investigational study staff. 14. Subject who produced an inadequate amount of sputum at the Screening Visit (Visit 1) or is known to have difficulty producing sputum. 15. Subjects with a PBN count of <3000/µL at the Screening Visit (Visit 1).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Part 1 - Adverse events and changes from Baseline for both absolute and percent peripheral blood neutrophil (PBN) counts. Part 2 - Changes from Baseline in pre-bronchodilator FEV1 and changes from Baseline in the daily AM/PM SCDS, both as longitudinal averages over the 12-week treatment period. ;Main Objective: Part 1 - To assess the safety and tolerability of 3, 10, and 30 mg of SCH 527123 compared with placebo in subjects with moderate to severe COPD. Part 2 - To assess the efficacy of 3, 10, and 30 mg of SCH 527123 compared with placebo in subjects with moderate to severe COPD, based on changes from Baseline in forced expiratory volume in one second (FEV1) and the sum of the individual symptoms of sputum production, cough, and dyspnea score.;Secondary Objective: Part 1 - To explore the effect of SCH 527123 compared with placebo on number and/or percent of sputum neutrophils. Sputum neutrophils, believed to play a key role in the pathophysiology of COPD, will be used as a surrogate marker for the activity of SCH 527123. A dose related decrease in sputum neutrophil counts may be regarded as proof-of-concept for SCH 527123. Part 2 - To evaluate the safety and tolerability of SCH 527123 in subjects with COPD. | — |
Countries
Germany
Outcome results
None listed