Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Product Name: GSK573719
Pharmaceutical Form: Inhalation powder, pre-dispensed
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 250-
Pharmaceutical form of the placeb
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female between 40 and 75 years of age. 2. A female subject is eligible to participate if she is of: Non childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy, bilateral salpingectomy or bilateral oophrectomy or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL and estradiol =65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects who have a past or present disease, which as judged by the Investigator, may affect subject safety or influence the outcome of the study. 3. The subject has a positive pre-study drug/alcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine and opiates. The detection of drugs taken for a legitimate medical purpose would not necessarily be an exclusion to study participation. The detection of alcohol would not be an exclusion at screening but would need to be negative pre-dose and during the study. 4. Female subject has a positive pregnancy test. 5. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening. 6. A positive test for HIV antibody (if tested, according to local SOP's). 7. History of high alcohol consumption within 1 month of the study defined as: • an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males), or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). One unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine. 8. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). 9. Exposure to more than four new chemical entities within 12 months prior to the first dosing day. 10. History of sensitivity to any of the study medications, or components thereof (including allergy to milk protein/lactose) or a history of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates their participation. 11. Subject has donated a unit (400 mL) of blood within 60 days of screening or, intends to donate during the study. 12. Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period. 13. Unwillingness or inability to follow the procedures outlined in the protocol. 14. The subject is unable to use the novel dry powder inhaler correctly. 15. The subject requires treatment for prostate hypertrophy. 16. The subject has a history of narrow angle glaucoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of repeat inhaled doses of GSK573719 MgSt (inhaled once daily for 7 days) in COPD subjects.;Secondary Objective: To assess the pharmacokinetics of GSK573719 MgSt following repeat inhaled doses (inhaled once daily for 7 days) in COPD subjects.;Primary end point(s): General safety and tolerability endpoints: adverse events, blood pressure, heart rate, 12-lead ECG, 24h Holter monitoring, lung function (FEV1), rescue medication usage (total number of salbutamol doses taken over the 7-day study period) and clinical laboratory safety tests. The following endpoints will be derived for the Vital Signs (heart rate) on Days 1 & 7: • Maximum value (0-4 hour) • Weighted Mean (0-4 hour) The following endpoints will be derived for the 24h Holter monitoring (heart rate) on Screening and Day 7: • Maximum value (0-24 hours) • Mean (0-24 hours) | — |
Countries
United Kingdom
Outcome results
None listed