Study is in COPD patients. MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Product Name: N/A
Product Code: GSK233705
Pharmaceutical Form: Inhalation powder, pre-dispensed
Pharmaceutical form of the placebo: Inhalation powder, pre-dispensed
Route of administration of the plac
Sponsors
GlaxoSmithKline Research and Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men or women who are between 40 and 75 years of age 2. Female subjects must be of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophrectomy or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy. 3. Subject diagnosed with COPD, as defined by the GOLD guidelines (see Appendix 5) 4. Body Mass Index 18.0 - 32.0 kg/m2 (inclusive) 5. Subject is a smoker or an ex-smoker with a smoking history of at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year or equivalent). 6. Subject has post-bronchodilator (200µg salbutamol) FEV1 of = 40% to = 80% of predicted normal. 7. Subject has FEV1/FVC =65 years) yes 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 and the Medical Monitor, may affect the outcome of this study. 2. The subject has a positive pre-study alcohol screen. The detection of alcohol would not be an exclusion at screening but would need to be negative pre-dose and during the study. 3. The subject has a positive pre-study drug screen. A minimum list of drugs that will be screened for include Amphetamines, Barbiturates, Cocaine and Opiates. The detection of drugs with a legitimate medical use would not be an exclusion to study participation. 4. History of alcohol/drug abuse or dependence within 12 months of the study: Abuse of alcohol defined as an average weekly intake of greater than 24 units. 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine. 5. The subject has a positive pregnancy test. 6. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening 7. The subject has participated in a clinical trial and has received a drug or a new chemical entity within 60 days or 5 half-lives, or twice the duration of the biological effect of any drug(whichever is longer) prior to the first dose of current study medication. 8. Exposure to more than three new chemical entities (NCE) within 10 months prior to the first dosing day or one NCE within 3 months prior to the first dosing day. 9. The subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study. 10. The subject has a known allergy or hypersensitivity to ipratropium bromide, atropine and any of its derivatives or milk protein/lactose. 11. History of sensitivity to any of the study medications, or components thereof (including Magnesium Stearate) or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation 12. Subject is unable to use the DISKUS™ device correctly. 13. Subject has prostate hypertrophy or narrow angle glaucoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of repeat inhaled doses of GSK233705B MgSt (inhaled twice daily for 7 days) in COPD patients.;Secondary Objective: To assess the pharmacokinetics of GSK233705 MgSt following repeat inhaled doses (inhaled twice daily for 7 days) in COPD patients. To assess the pharmacodynamics of GSK233705 MgSt following repeat inhaled doses (inhaled twice daily for 7 days) in COPD patients.;Primary end point(s): General safety and tolerability endpoints: adverse events, blood pressure, heart rate, 12-lead ECG, Holter and Lead II ECG monitoring, lung function (FEV1, FVC), 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, systolic and diastolic blood pressure) and the ECG parameters QTc (F) and QTc (B) on Days 1 and 7: Maximum value (0-4 hour) for the morning dose Weighted Mean (0-4 hour) for the morning dose | — |
Countries
Netherlands
Outcome results
None listed