Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2) | NCT06961214 | Trialant

Depemokimab as an Extended treatmeNt Duration Biologic in Adults With Chronic Obstructive Pulmonary Disease (COPD) and Type 2 Inflammation (ENDURA-2) | NCT06961214 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Participants must be greater than or equal to (>=) 40 to less than or equal to (<=) 80 years of age, at the time of signing the Informed consent

Elevated Blood Eosinophil Count (BEC)

Moderate to severe COPD with frequent exacerbations, defined as:

A clinically documented history of COPD as defined by the American Thoracic Society/European Respiratory Society for at least 1 year

A post-bronchodilator forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ratio of < 0.70 and a post-bronchodilator FEV1 >30 percent (%) and <= 80% predicted normal values

A well-documented history of at least 2 moderate or 1 severe exacerbation in the 12 months prior to screening

COPD assessment test (CAT) score >=10 at Visit 1

Smoking status: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years.

Participants should be on optimized inhaler therapy, defined as inhaled corticosteroid (ICS) plus Long-acting muscarinic receptor antagonist (LAMA) plus Long-acting beta2-adrenergic receptor agonist (LABA) either as multiple inhalers or a single combination inhaler for at least 6 months prior to Screening Visit 1

Body mass index (BMI) >=16 kilogram per square meter (kg/m^2)

Male and eligible female participants

Exclusion Criteria:

The following subjects are excluded:

Participants with a current or prior physician diagnosis of asthma

Other clinically significant lung disease: The Investigator must judge that COPD is the primary diagnosis accounting for the clinical manifestations of the lung disease

Participants with pneumonia, COPD exacerbation, or lower respiratory tract infection within the 4 weeks prior to Screening Visit 1

Lung resection: Participants with a history of or plan for lung volume reduction surgery / endobronchial valve procedure.

Pulmonary rehabilitation: Participants in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1

Continuous oxygen: Participants requiring oxygen supplementation for more than 12 hours per day

Cor pulmonale - resulting in right heart failure, severe pulmonary hypertension

Chronic hypercapnia requiring Non-invasive positive pressure ventilation (NIPPV) use (including Bi-Level Positive Airway Pressure [BiPAP] or Continuous Positive Airway Pressure [CPAP])

Unstable cardiovascular disease or arrhythmia

Parasitic Infection: Participants with a known, pre-existing parasitic infection within 6 months of Screening (Visit 1)

GSK Investigational SiteRecruiting

Sheffield, Alabama 35660, United States

US GSK Clinical Trials Call CenterContact

GSKClinicalSupportHD@gsk.com877-379-3718

EU GSK Clinical Trials Call CentreContact

GSKClinicalSupportHD@gsk.com+44 (0) 20 8990 4466

Aaron KarrPrincipal Investigator

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Aurora, Colorado 80012, United States

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Brooksville, Florida 346135, United States

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Doral, Florida 33172, United States

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Fort Lauderdale, Florida 33316, United States

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Miami, Florida 33122, United States

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Miami, Florida 33125, United States

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Miami, Florida 33155, United States

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Miami, Florida 33165, United States

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Miami, Florida 33175, United States

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Miami, Florida 33176, United States

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Miami, Florida 33176, United States

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Miami Lakes, Florida 33016, United States

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Naples, Florida 34102, United States

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New Port Richey, Florida 34653, United States

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Ocala, Florida 34471, United States

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Orlando, Florida 32825, United States

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Ormond Beach, Florida 32174, United States

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Palmetto Bay, Florida 33157, United States

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St. Petersburg, Florida 33704, United States

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Adairsville, Georgia 30103, United States

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Cordele, Georgia 31015, United States

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East Point, Georgia 30344, United States

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Morrow, Georgia 30260, United States

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Boise, Idaho 83702, United States

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Chicago, Illinois 60608, United States

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Baton Rouge, Louisiana 70816, United States

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Lafayette, Louisiana 70506, United States

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Shreveport, Louisiana 71105, United States

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Bangor, Maine 04401, United States

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Rockville, Maryland 20854, United States

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Allen Park, Michigan 48101, United States

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Detroit, Michigan 48202, United States

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Garden City, Michigan 48135, United States

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Troy, Michigan 48085, United States

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Las Vegas, Nevada 89144, United States

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Moorestown, New Jersey 08057, United States

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Sewell, New Jersey 08080, United States

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Mount Kisco, New York 10549, United States

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New Windsor, New York 12553, United States

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Shelby, North Carolina 28152, United States

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DuBois, Pennsylvania 15801, United States

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Philadelphia, Pennsylvania 19140, United States

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Spartanburg, South Carolina 29303, United States

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Union, South Carolina 29379, United States

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Knoxville, Tennessee 37919, United States

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Austin, Texas 78744, United States

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Dallas, Texas 75254, United States

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El Paso, Texas 79902-1123, United States

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Houston, Texas 77094, United States

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Lampasas, Texas 76550, United States

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Richmond, Texas 77407, United States

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San Antonio, Texas 78229, United States

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Webster, Texas 77598, United States

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Morgantown, West Virginia 26505-0423, United States

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Buenos Aires, C1425BAD, Argentina

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Buenos Aires, C1426ABP, Argentina

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Córdoba, X5800AEV, Argentina

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Quilmes, 1878, Argentina

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Santa Fe, S3000ASF, Argentina

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Coffs Harbour, New South Wales 2450, Australia

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Maroubra, New South Wales 2035, Australia

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Westmead, New South Wales 2145, Australia

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Midland, Western Australia 6056, Australia

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Graz, 8036, Austria

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Innsbruck, 6020, Austria

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Klagenfurt, 9020, Austria

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Linz, 4020, Austria

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Linz, 4020, Austria

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Linz, 4021, Austria

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Vienna, A-1090, Austria

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Dupnitsa, 2600, Bulgaria

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Haskovo, 6300, Bulgaria

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Lovech, 5500, Bulgaria

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Montana, 3400, Bulgaria

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Montana, 3400, Bulgaria

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Pleven, 5800, Bulgaria

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Rousse, 7002, Bulgaria

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Rousse, 7002, Bulgaria

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Sofia, 1510, Bulgaria

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Sofia, 1680, Bulgaria

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Jindřichův Hradec, 377 01, Czechia

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Kralupy nad Vltavou, 278 01, Czechia

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Nymburk, 288 02, Czechia

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Prague, 12000, Czechia

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Varnsdorf, 407 47, Czechia

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Munich, Bavaria 80335, Germany

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Offenbach, Hesse 63065, Germany

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Rheine, North Rhine-Westphalia 48431, Germany

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Bendorf, 56170, Germany

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Berlin, 10119, Germany

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Berlin, 10625, Germany

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Berlin, 10717, Germany

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Berlin, 10961, Germany

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Berlin, 12203, Germany

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Berlin, 12627, Germany

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Berlin, 13187, Germany

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Darmstadt, 64283, Germany

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Essen, 45127, Germany

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Fürstenwalde, 15517, Germany

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Geesthacht, 21502, Germany

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Giessen, 35392, Germany

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Halle, 6108, Germany

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Immenhausen, 34376, Germany

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Leipzig, 04207, Germany

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Leipzig, 04299, Germany

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Leipzig, 04347, Germany

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Lübeck, 23552, Germany

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Schleswig, 24837, Germany

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Exochi, Thessaloniki 57010, Greece

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Alexandroupoli, 68100, Greece

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Athens, 115 21, Greece

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Ioannina, 45500, Greece

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Marousi, 151 25, Greece

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Ashkelon, 7830604, Israel

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Beer-Yaakov, 703000, Israel

US GSK Clinical Trials Call CenterContact

GSKClinicalSupportHD@gsk.com877-379-3718

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Beersheba, 84101, Israel

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Haifa, 30000, Israel

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Haifa, 3109601, Israel

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Haifa, 3436212, Israel

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Jerusalem, 90000, Israel

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Jerusalem, 91031, Israel

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Kfar Saba, 44281, Israel

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Petah Tikva, 49100, Israel

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Ramat Gan, 52621, Israel

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Catania, 95123, Italy

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Ferrara, 44124, Italy

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Foggia, 71122, Italy

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Genova, 16132, Italy

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Roma, 00128, Italy

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Roma, 00133, Italy

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Roma, 00161, Italy

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Telese Terme, 82037, Italy

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Daugavpils, LV5410, Latvia

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Riga, LV 1079, Latvia

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Riga, LV-1002, Latvia

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Takapuna, Auckland 0622, New Zealand

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Auckland, 1051, New Zealand

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Auckland, 1051, New Zealand

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Christchurch, 8023, New Zealand

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Ebdentown, 5018, New Zealand

US GSK Clinical Trials Call CenterContact

GSKClinicalSupportHD@gsk.com877-379-3718

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Hamilton, 3240, New Zealand

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Rotorua, 3010, New Zealand

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Oradea, Bihor County 410155, Romania

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Oradea, Bihor County 410176, Romania

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Timișoara, Timiș County 300310, Romania

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Bucharest, 061692, Romania

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Cluj-Napoca, 400275, Romania

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Cluj-Napoca, 400371, Romania

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Constanța, 900002, Romania

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Seoul, 03181, South Korea

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Seoul, 5030, South Korea

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Corby, NN17 2UR, United Kingdom

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Dagenham, RM9 5NH, United Kingdom

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Glasgow, G20 7BE, United Kingdom

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Glasgow, G4 0SF, United Kingdom

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London, N8 0RA, United Kingdom

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London, NW10 2PB, United Kingdom

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Uxbridge, UB8 3NN, United Kingdom