Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 9.1 Level: LLT Classification code 10009033 Term: Chronic obstructive pulmonary disease
Conditions
Interventions
Product Name: PF-00610355
Pharmaceutical Form: Inhalation powder
CAS Number: 862541-45-5
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 184-
Pharmaceutical form of
Sponsors
Pfizer Ltd, Ramsgate Road, Sandwich, Kent, UK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Male and/or female subjects between the ages of 40 and 80 years, inclusive with a diagnosis of moderate COPD (GOLD, 2007 update) and who meet the following criteria for GOLD stage II disease: • Post-bronchodilator FEV1/ FVC ratio of =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. Subjects having more than 2 exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year. 2. Use of prescription or non-prescription drugs as follows: • Subjects on medication having a significant effect on cardiac rate, conduction system (including QT interval) or myocardial function. • Subjects on medication known to be cytochrome P-450 3A4 inhibitors (eg, antiinfective agents such as erythromycin, triazole anti-fungal agents, chloramphenicol and fluvoxamine) or cytochrome P-450 3A4 inducers (eg, phenobarbital and phenytoin). • Subjects on inhaled corticosteroids. 3. Subjects on ß-blockers. 4. Subjects with uncontrolled hypertension. Stable hypertensive subjects are permitted but must remain on their anti-hypertensive medication through out the study and not change drug, regime or dose etc during the trial. 5. History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization. 6. History or presence of respiratory failure, cor pulmonale or right ventricular failure. 7. Apart from COPD, 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). 8. Abnormal 12-lead ECG including evidence of ischaemia, myocardial infarction, arrhythmia or QTc >430 msec for women/QTc >450 msec for men. (If QTc exceeds these limits, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject’s eligibility). Patients with familial long QT syndrome are also excluded. 9. A resting pulse rate >100 bpm or 1.5 x upper limit of normal (ULN). • Aspartate amino transferase >1.5 x ULN. • Alkaline phosphatase >1.2 x ULN. • Total bilirubin >1.5 x ULN. 13. A ferritin level <lower limit of normal. 14. A potassium level <lower limit of normal. 15. Positive HBsAg, HBcAB or anti-hepatitis C virus serology. 16. Use of any investigational drug within 3 months prior to dosing. 17. History of severe drug induced hypersensitivity (ie, anaphylaxis). 18. Known lactose intolerance or contraindicated for rescue/maintenance medication. 19. A positive urine drug screen. 20. History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for men (1 drink = 150 mL of wine or 360 mL of beer or 45 mL of spirits) within 6 months of screening. 21. Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception as outlined in this protocol from at least 14 days prior to the first dose of study me
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD patients. • To evaluate the safety & toleration of single inhaled doses of PF-00610355 in COPD patients.;Secondary Objective: • To investigate the efficacy of a single inhaled dose of PF-00610355 in COPD patients. • To investigate the exposure/response relationship of PF-00610355 versus ß2-mediated extra pulmonary effects in COPD patients in conjunction with prior knowledge from HV and asthmatic population, specifically: heart rate, blood pressure, QTc, arrhythmias, plasma potassium and blood glucose.;Primary end point(s): 1.PF-00610355 PK: AUCinf, AUClast, Tmax, Cmax, T½. 2. Systemic safety: Maximal and weighted mean (AUEC) change from baseline over 24 hr post dose in heart rate (pulse rate), plasma potassium, blood glucose, blood pressure and QTc. | — |
Countries
Germany
Outcome results
None listed