in subjects with Chronic Obstructive Pulmonary Disease COPD MedDRA version: 17.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Product Name: Umeclidinium
Product Code: GSK573719
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: UMECLIDINIUM BROMIDE
CAS Number: 869113-09-7
Current Sponsor code: GSK573
Sponsors
GlaxoSmithKline Research & Development 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: Subjects 40 years of age or older at Visit 1. 4. Gender: Male and female subjects are eligible to participate in the study. OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study – screening to follow-up contact): - Abstinence - Oral Contraceptive, either combined or progestogen alone - Injectable progestogen - Implants of levonorgestrel - Estrogenic vaginal ring - Percutaneous contraceptive patches - Intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness criteria as stated in the product label - Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, “documented” refers to the outcome of the investigator's/designee’s medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject’s medical records. - Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository) 5. Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]. 6. Smoking History: Current or former cigarette smokers with a history of cigarette smoking of = 10 pack-years [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use cannot be used to calculate pack year history. 7. Severity of Disease: A pre and post-albuterol/salbutamol FEV1/FVC ratio of =65 years) yes F.1.3.1 Number of subjects for this age range 81
Exclusion criteria
Exclusion criteria: 1. Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study. 2. Asthma: A current diagnosis of asthma. 3. Other Respiratory Disorders: Known alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. Please view protocol for further information. 4. Other Diseases/Abnormalities: The subject is considered unlikely to survive the duration of the study period or has any rapidly progressing disease or immediately life-threatening illness e.g. cancer. 5. Contraindications: Any history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, sympathomimetic, corticosteroid (intranasal, inhaled or systemic) lactose/milk protein or magnesium stearate. . 6. Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1. 7. Lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Visit 1. 8. Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Visit 1. 9. Unstable or life threatening cardiac disease: Umeclidinium/vilanterol should be used with caution in subjects with severe cardiovascular disease. Please view protocol for further information. 10.12-Lead ECG: Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. Please view protocol for further information. 11.Antimuscarinic effects: Subjects with medical conditions such as narrow-angle glaucoma, prostatic hypertrophy, or bladder neck obstruction should only be included if, in the opinion of the study physician, the benefit outweighs the risk. 12.Interactions: Concomitant administration with beta-blockers and strong CYP3A4 inhibitors is only permitted if, in the Investigator’s opinion, the likely benefit outweighs the potential risk. 13.Severe Hepatic Impairment: Patients with severe hepatic impairment (Child- Pugh class C) should be excluded unless, in the opinion of the investigator, the benefit is likely to outweigh the risk. 14.Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit. 15.Medications Prior to Screening: please view table and further information within the protocol. 16.Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e., 12 hours per day) is not exclusionary. 17.Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g., albuterol/salbutamol) via nebulized therapy. 18.Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1, or who will enter the acute phase of a pulmonary rehabilitation program during the study. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded. 19.Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1. 20.Affiliation with Investigator Site: A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, subinvestigator, study coordinator, or employee of the part
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the efficacy and safety of the addition of UMEC 62.5mcg once-daily to ICS/LABA therapy, compared with placebo once-daily plus ICS/LABA therapy over 12 weeks in subjects with COPD.;Secondary Objective: The secondary objective is to evaluate the addition of UMEC 62.5mcg once-daily to ICS/LABA therapy, compared with placebo once-daily plus ICS/LABA therapy on COPD-related health status assessments over 12 weeks in subjects with COPD.;Primary end point(s): Trough FEV1 on Day 85. Trough FEV1 on Treatment Day 85 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on treatment Day 84 (i.e., at Week 12). ;Timepoint(s) of evaluation of this end point: Day 85 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Weighted mean (WM) 0-6 hour FEV1. Other(s) • Proportion of subjects achieving an increase of =100mL above baseline in trough FEV1 • Trough FEV1 and weighted mean FEV1 over 0-6 hours post-dose at other time points • Proportion of subjects achieving an increase in FEV1 of =12% and =200mL above baseline at any time during 0-6 hour post-dose on Day 1 • Serial FEV1 over 0 to 6 hours (at each time point) • Peak FEV1 • Serial and trough forced vital capacity (FVC) • Rescue albuterol/salbutamol use (percentage of rescue-free days and puffs/day) • TDI focal score • Proportion of TDI responders as defined by a 1 unit or greater score Safety • Incidence of adverse events • Vital signs (pulse rate and systolic and diastolic pressure) • COPD Exacerbations Health-Related Quality of Life/Health Outcomes • St. George’s Respiratory Questionnaire for COPD Patients (SGRQ-C) total score • COPD Assessment Test (CAT) score • Proportion of SGRQ responders as defined by a 4 unit or greater reduction in score over baseline • Proportion of CAT responders as defined by a 2 unit or greater improvement in score over baseline ;Timepoint(s) of evaluation of this end point: post-dose on Treatment Day 84 (Week 12) | — |
Countries
Czech Republic, Germany, Greece, Netherlands
Contacts
Public ContactClinical Trials HelpDesk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed