Subjects with COPD. MedDRA version: 18.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Product Name: batefenterol
Product Code: GSK961081
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: Batefenterol
CAS Number: 945905-37-3
Other descriptive name: GSK 961081
Co
Sponsors
GlaxoSmithKlineResearch & Developemnt Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type of subject: Outpatient. 2. Informed Consent: A signed and dated written informed consent prior to study participation. 3. Age: 40 years of age or older at Visit 1. 4. Gender: Male and female subjects are eligible to participate in the study. Female subjects are eligible to participate if not pregnant (as confirmed by a negative urine human chorionic gonadotrophin (hCG) test), not lactating, and at least one of the following conditions applies: a. Non-reproductive potential defined as: - Pre-menopausal females with one of the following: - Documented tubal ligation - Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion - Hysterectomy - Documented Bilateral Oophorectomy Postmenopausal defined as 12 months of spontaneous amenorrhea. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status prior to study enrolment. b. Reproductive potential and agrees to follow one of the options listed below 30 days prior to the first dose of study medication and until at least five terminal half-lives OR until any continuing pharmacologic effect has ended, whichever is longer after the last dose of study medication and completion of the follow-up visit. This list does not apply to females of reproductive potential with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penile-vaginal intercourse on a long term and persistent basis. - Contraceptive subdermal implant that meets 10 pack-years. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g. 20 cigarettes per day for 10 years,
Exclusion criteria
Exclusion criteria: 1. Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD). 2. Other Respiratory Disorders: Known respiratory disorders other than COPDPlease view protocol for further information. 3. Other Diseases/Abnormalities: Any significant diseases (including uncontrolled hypertension, diabetes and thyroid disease) please view protocol for further information 4. Hepatitis: Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at Screening Visit 1 or within 3 months prior to first dose of study treatment. Please view protocol for further information. 5. Liver Disease: Current or chronic history of liver disease, known hepatic or biliary abnormalities (with the exception of Gilbert’s syndrome or asymptomatic gallstones). 6. Cancer: A current malignancy or previous history of cancer in remission for < 5 years prior to Visit 1, please view protocol for further information. Any current or previous history of throat cancer. 7. Chest X-Ray: A chest X-ray or computed tomography (CT) scan that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. Please view protocol for further information. 8. Drug Allergy: A history of hypersensitivity or allergy to any beta adrenergic receptor-agonist, sympathomimetic, anticholinergic/anti-muscarinic receptor antagonist, or lactose/milk protein, which in the opinion of the investigator or GSK medical monitor contraindicates study participation. 9. Diseases Preventing Use of Anticholinergic: 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. 10. Poorly controlled COPD: defined as the occurrence of ‘acute worsening of COPD that is managed with corticosteroid and/or antibiotics or that requires treatment prescribed by a physician in the 6 weeks prior to Screening (Visit 1)’, or ‘subjects who are hospitalized due to acute worsening of COPD within 12 weeks of Visit 1’. 11. History of COPD exacerbation: Subjects who have had more than one exacerbation (moderate or severe) within the 12 months prior to Visit 1. See protocol Section 7.4.7 for the protocol definition of moderate/severe COPD exacerbation. 12. Pneumonia and lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Visit 1 or subjects hospitalized due to pneumonia within 12 weeks of Visit 1. 13. Lung Resection: Lung volume reduction surgery within the 12 months prior to Visit 1. 14. 12-lead ECG: An abnormal and clinically significant 12-lead electrocardiogram (ECG). Please view protocol for further information. For this study, an abnormal and clinically significant ECG that would preclude a subject from entering the trial is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following: please see protocol for further information. 16. Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit. 17. Excluded Medications: Use of the following medications please view protocol for further information, are not permitted within the defined time intervals prior to Visit 1 and throughout the study: 17. Oxygen: Use of long-term oxygen th
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the dose response, efficacy and safety of five dosage regimens of batefenterol delivered via the DPI in subjects with COPD.;Secondary Objective: To investigate the PK and PD of batefenterol in subjects with COPD Exploratory: To evaluate treatment effect of batefenterol on Patient Reported Outcomes in subjects with COPD;Primary end point(s): Weighted-mean FEV1 over 0 to 6 hours post-dose at Day 42;Timepoint(s) of evaluation of this end point: Day 1: -30minutes and 0 minutes pre-dose and post-dose at 5, 15, and 30 minutes and 1, 2, 4 and 6 hours; Day 42: trough 23rd and 24th hour assessments will be collected first. The 6 hr serial timepoints will then be performed following dosing at 5, 15, and 30 min and 1, 2, 4 and 6 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy: Trough FEV1 at Day 42 Other Efficacy: -Time to onset (defined as an increase of 100mL above baseline in FEV1) during 0-6 hours post-dose on Treatment Day 1 -Proportion of subjects achieving an increase of = 100mL above baseline on Day1 and Day 42 - Trough FEV1 and weighted-mean FEV1 over 0-6 hours post-dose at other time points - Serial FEV1 over 0 to 6 hours post-dose (at each time point) on Day 1 and Day 42 - Serial FVC over 0 to 6 hours post-dose (at each time point) on Day 1 and Day 42 - Albuterol/salbutamol use (occasions/day), averaged over each week of treatment and over the 42-day treatment period. - The percentage of albuterol/salbutamol rescue-free days (24 hours) during each week of treatment and over the 42-day treatment period. Safety: - Incidence of AEs - Vital signs (pulse rate, systolic and diastolic blood pressure) - 12-lead ECG assessments - Clinical laboratory tests (haematology and chemistry) - Fasting glucose and potassium assessments - Incidence of COPD exacerbations Secondary: Plasma batefenterol concentrations and derived PK parameters. Exploratory: - COPD Assessment Test (CAT) - Taste Questionnaire;Timepoint(s) of evaluation of this end point: Performed at 23 and 24 hours at Days 7, 14, 28 and 42 of the study. | — |
Countries
Germany, South Africa, United States
Contacts
Public ContactClinical Trials Helpdesk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed