Chronic obstructive pulmonary disease (COPD). Classification code 10009033
Conditions
Interventions
Product Name: UK-500,001
Product Code: UK-500,001
Pharmaceutical Form:
INN or Proposed INN: Not available
Current Sponsor code: UK-500,001
Other descriptive name: cis-2-(3,4-Difluorophenoxy)-5-fluoro
Sponsors
Pfizer Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients between, and including, the ages of 40 and 80 years. Females need to be of either non-childbearing potential; or if of childbearing potential may be included providing they are using acceptable methods of contraception. 2. Patients with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD, 2003 revision) and who meet the following criteria for Stage II III disease: Patients must have a post-bronchodilator FEV1/FVC ratio 40 kg. 6. Patients must be able to give informed written consent prior to entering the study. 7. Patients 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. Patients 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, hepatitis B or C carrier status or chronic active hepatitis of any etiology (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 transient ischemic attacks). 9. Active tuberculosis within the previous 2 years. 10. History within the previous 6 months of: a) an epileptic seizure. b) poorly controlled Type 1 or Type 2 diabetes. c) acute hepatitis of any etiology. 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 without Pfizer approval. This assessment is made by the investigator at the time of ECG collection. c) Atrioventricular (AV) block greater than first degree. d) Resting heart rate >100 or <40 bpm. e) 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. Patients with certain chronic conditions such as hypertension, thyroid disease, Type 1 or Type 2 diabetes, hypercholesterolemia, gastroesophageal reflux, or depression may be 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 safety or interfere with the tests and interpretations of this study. 15. Female patients of childbearing potential who are unwilling or unable to use an acceptable method of contraception from screening until c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy and safety/tolerability of UK-500,001 DPI in adults with moderate to severe COPD (Global initiative in Obstructive Lung Disease [GOLD] stage II/III).;Secondary Objective: 1. To explore the efficacious dose range for UK-500,001 DPI in COPD and provide information for a Phase IIb dose ranging. 2. To evaluate the time course of response to UK-500,001 DPI. 3. To evaluate the persistence of UK-500,001 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-500,001 exposure vs. efficacy and/or safety/tolerability in COPD patients.;Primary end point(s): Mean change from baseline in trough (prior to administration of study drug) FEV1 at Week 6. | — |
Countries
Czech Republic, Hungary, Spain, United Kingdom
Outcome results
None listed