Chronic obstructive pulmonary disease (COPD). MedDRA version: 8.1 Level: LLT Classification code 10009033 Term: Chronic obstructive pulmonary disease
Conditions
Interventions
Product Name: UK-432,097
Product Code: UK-432,097
Pharmaceutical Form: Inhalation powder, hard capsule
Current Sponsor code: UK-432,097
Sponsors
Pfizer Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects between, and including, the ages of 40 and 80 years. Females need to be of non-childbearing potential. Females of non-child-bearing potential will be defined as: • Females over the age of 60 years. • Females who are 40-60 years of age who have been amenorrheic for at least 2 years and have a serum FSH level >30 IU/L in the absence of hormone replacement therapy or have a documented hysterectomy. 2. Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease: • Subjects must have a post-bronchodilator FEV1/FVC ratio 40 kg. 6. Subjects must be able to give informed written consent prior to entering the study. 7. Subjects must be willing and able to comply with scheduled visit and all study related procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalization for the treatment of COPD within 3 months of screening or more than twice during the preceding year. 2. History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomization. 3. History or presence of respiratory failure, cor pulmonale or right ventricular failure. 4. Subjects with home oxygen therapy (either PRN or long term oxygen therapy, LTOT). 5. Any clearly documented history of adult asthma or other chronic respiratory disorders (e.g. bronchiectasis, pulmonary fibrosis, pneumoconiosis). 6. Known previous diagnosis of HIV infection (specific screening is not required). 7. History of cancer (other than cutaneous basal cell) in the previous 5 years. 8. History within the previous year of: myocardial infarction, cardiac arrhythmia (e.g. atrial fibrillation, paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia), left ventricular failure, unstable angina, coronary angioplasty, coronary artery bypass grafting (CABG) or cerebrovascular accident (including transientischemic attacks). 9. Active tuberculosis within the previous 2 years. 10. History within the previous 6 months of: • An epileptic seizure. • Poorly controlled Type 1 or Type 2 diabetes. • Acute hepatitis of any aetiology. 11. A major surgical operation within 1 month of screening. 12. Screening systolic blood pressure 450 msec for men; >470 msec for women) are not eligible for randomization. This assessment is made by the investigator at the time of ECG collection. • Atrioventricular (AV) block greater than first degree. • Resting heart rate >100 or <40 bpm. • Evidence of previous myocardial infarction or significant ischemic changes in the absence of clinical history consistent with these findings. 14. History or evidence, based upon a complete medical history, full physical examination, posterior-anterior chest X-ray (within last 12 months), 12-lead resting ECG or clinical laboratory test results, of any other significant concomitant clinical disease that, in the opinion of the investigator, could interfere with the conduct, safety or interpretation of results of this study. Subjects with certain chronic conditions such as hypertension, thyroid disease, Type 1 or Type 2 diabetes, hypercholesterolemia, gastroesophageal reflux, or depression maybe included in the study as long as the conditions are well controlled and medications relating to the condition are stable and would not be predicted to compromise
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety/tolerability of UK-432,097 DPI in adults with moderate to severe COPD (GOLD stage II/III).;Primary end point(s): Change from baseline in through (prior to administration of study drug) FEV1 at Week 6.; Secondary Objective: 1. To explore the efficacious dose range for UK-432,097 DPI in COPD and provide information for Phase 2b dose ranging study(ies). 2. To evaluate the time course of response to UK-432,097 DPI. 3. To evaluate the washout / persistence of UK-432,097 DPI effects on lung function and symptoms for two weeks after stopping the drug. 4. To evaluate the PK-PD relationship between dose and/or systemic UK-432,097 exposure vs. efficacy and/or safety/tolerability in COPD subjects. | — |
Countries
Netherlands, United Kingdom
Outcome results
None listed