Chronic Obstructive Pulmonary Disease MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Product Name: not applicable
Product Code: PF-00610355
Pharmaceutical Form: Inhalation powder
CAS Number: 862541-45-5
Current Sponsor code: PF-00610355
Concentration unit: µg microgram(s)
Concentratio
Sponsors
Pfizer Limited, Ramsgate Road, Sandwich, Kent UK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator's study team before subjects are included in the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 2. Male or female patients between, and including, the ages of 40 and 80 years. Females may be of either childbearing or non-child bearing potential. Females of non-childbearing 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 who have a serum FSH level >30 IU/L in the absence of hormone replacement therapy, or - Females with a documented hysterectomy. All females of childbearing potential may be included provided they are not pregnant (negative serum in pregnancy test at screening) or nursing, and are practicing acceptable contraception methods -Abstinence. -Tubal ligation. -Physician documented placement of copper-containing intrauterine device (IUD). -Diaphragm with spermicidal foam/gel/film/cream/pessary. -Condom with spermicidal foam/gel/film/cream/pessary. -Male partner who has had a vasectomy. -Hormonal contraceptives (oral, injected, transdermal or implanted) in conjunction with a barrier method of contraception listed above. -Hormonal contraceptives provided the subject remains on the treatment throughout the entire study and has been using hormonal contraceptives for an adequate period of time to ensure effectiveness (eg, 3 months for hormonal contraceptives). 3. Patients with a diagnosis, for at least 6 months, of moderate COPD (GOLD 2007) and who meet the criteria for Stage II disease: Patients must have a post-bronchodilator1 FEV1/FVC ratio 40 kg. 7. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study 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: Subjects presenting with any of the following will not be included in the study: 1. More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalisation 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 randomisation. 3. History or presence of respiratory failure, cor pulmonale or right ventricular failure. Patients with home oxygen therapy (either PRN or long term oxygen therapy). 5. Any clearly documented history of adult asthma (onset of symptoms prior to the age of 40 years) or other chronic respiratory disorders (eg, bronchiectasis, pulmonary fibrosis, pneumoconiosis). 6. Known previous diagnosis of HIV infection (specific screening is not required), hepatitis B or C carrier status or chronic active hepatitis of any aetiology. 7. History within the previous year of: myocardial infarction, cardiac arrhythmia (eg, 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). 8. History within the previous 6 months of: - An epileptic seizure. - Poorly controlled Type 1 or Type 2 diabetes (as indicated by an HbA1c of 10% or greater). - Acute hepatitis of any aetiology. 9. A major surgical operation within 1 month of screening. 10. Screening systolic blood pressure 450 msec) are not eligible for randomisation. 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 3 x upper limit of normal (ULN). -Aspartate amino transferase >3 x ULN. - Alkaline phosphatase >1.5 x ULN. - Total bilirubin >ULN. 15. Participation in other studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test all doses (100, 300 and 600 µg QD) of PF-00610355 and salmeterol 50 µg (BID) for superior efficacy on trough FEV1 vs placebo at Week 6.;Secondary Objective: To test all doses of PF-00610355 and salmeterol 50 µg for superior efficacy on peak FEV1 vs placebo at Day 1 and Week 6. To characterise dose/response vs placebo at Week 6. To test all doses of PF-00610355 and salmeterol for superior efficacy on QOL, COPD symptoms, and dyspnea and rescue medication use vs placebo. To test all doses and salmeterol for superior efficacy vs placebo at Weeks 2 and 4. To investigate the dose response relationship of PF-00610355 vs ß2-mediated extra pulmonary effects in COPD patients, specifically: heart rate, blood pressure, QTc, arrhythmias and plasma potassium.;Primary end point(s): Change from baseline in trough FEV1 at Week 6. | — |
Countries
Bulgaria, Czech Republic, Estonia, Germany, Hungary, Poland, Slovakia, Spain
Outcome results
None listed