Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Product Name: GSK961081B (edisilate salt)
Product Code: GSK961081B
Pharmaceutical Form: Inhalation powder
Pharmaceutical form of the placebo: Inhalation powder
Route of administration of the placebo:
Sponsors
GlaxoSmithKline Reaseach & Development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Subject is male or female (of non-child bearing potential) = 40 years of age and = 75 years of age. Non- child bearing potential is defined as physiologically incapable of becoming pregnant, including females who are post-menopausal (more than 2 years without menses with appropriate clinical history i.e. age, history of vasomotor symptomsestradiol and FSH levels may be checked if indicated) and females who are surgically sterile (hysterectomy, tubal ligation or bilateral oophorectomy). 2. Subject diagnosed with COPD in accordance with ATS/ERS guidelines. 3. Subject is a smoker or an ex-smoker with a history of at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year or equivalent) 4. Subject has FEV1/FVC 12 % and > 150 mL within 2 hours following inhalation of 80 µg ipratopium bromide (Atrovent MDI via spacer) at the screening visit Or: a documented increase in FEV1 of >12 % and > 150 mL within 2 hours following inhalation of 80 µg ipratopium bromide within 6 months of screening and an increase in FEV1 of > 6 % and > 100 mL within 2h following inhalation of 80 µg ipratopium bromide (Atrovent MDI via spacer) at the screening visit (in order to allow for potential fluctuations in the response to ipratropium bromide in patients known to be responders to ipratropium bromide) 7. Response to salbutamol defined as: Either an increase in FEV1 of > 12 % and > 150 mL within 2 hours following inhalation of 400 µg salbutamol MDI (via spacer) at the screening visit Or: a documented increase in FEV1 of >12 % and > 150 mL within 2 hours following inhalation of 400 µg salbutamol MDI within 6 months of screening and an increase in FEV1 of > 6 % and >100 mL within 2h following inhalation of 400 µg salbutamol MDI (via spacer) at the screening visit (in order to allow for potential fluctuations in the response to salbutamol in patients known to be responders to salbutamol) 8. Body mass index (BMI) within the range 18-35 kg/m2 9. Subject is able and willing to give written informed consent to take part in the study. 10. Subject is available to complete all study assessments 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: A subject will not be eligible for inclusion in this study if any of the following criteria apply: 1. Subjects who have a past or present disease, which as judged by the Investigator and medical monitor may affect the outcome of the study or the safety of the subject 2. Subjects with clinically relevant findings on laboratory safety tests. 3. Women who are pregnant or lactating 4. An unwillingness of subjects to abstain from sexual intercourse with pregnant or lactating women; or an unwillingness of the subject to use a condom/spermicide in addition to having their female partner use another form of contraception such as IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or tubal ligation if the woman could become pregnant from the time of the first dose study medication until 90 days post-dose 5. The subject has a positive urine drugs of abuse screen. 6. A history, or suspected history, of alcohol abuse within the 6 months before the screening visit. 7. A positive test for hepatitis C antibody, hepatitis B surface antigen, or HIV. 8. The subject has participated in a clinical study with another New Chemical Entity within the past 2 months or participated in a clinical study with any other drug during the previous month. 9. The subject has donated a unit of blood within the 56 days of dosing or intends to donate within 56 days after completing the study. 10. Subject has an FEV1 1000 µg FP (or equivalent) a day of inhaled corticosteroid or has changed dose within the 6 weeks before screening or is predicted not to be able to maintain a constant dose during the study 23. Subject is receiving oxygen therapy or nocturnal positive pressure treatment 24. Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that in the opinion of the study investigator would prevent use of an inhaled anticholinergic 25. The subject is unable to use the dosing devices (MDPI/ MDI/ spacer) correctly. 26. Subject with carcinoma that has not been in complete remission for at least 5
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the pulmonary pharmacodynamic profile of single doses of GSK961081 alone and in combination with cumulative doses of short acting bronchodilators (salbutamol and ipratropium bromide) in COPD patients.;Secondary Objective: To assess the systemic pharmacodynamics of single doses of GSK961081 in combination with cumulative doses of short acting bronchodilators (salbutamol and ipratropium bromide) as measured by heart rate, 12-lead ECG including QTc(B) and QTc (F), blood pressure, serum potassium and blood glucose in COPD patients. To assess the systemic pharmacokinetics of single doses of GSK961081 in combination with cumulative doses of short acting bronchodilators (salbutamol and ipratropium bromide) in COPD patients.;Primary end point(s): Maximal increase from pre-dose short-acting bronchodilator (salbutamol or ipratropium bromide) in FEV1 after inhalation of short-acting bronchodilator at 1h, 12h and 24h. | — |
Countries
United Kingdom
Outcome results
None listed