Study in Patients' With Persistent Asthma and Chronic Obstructive Pulmonary Disease

NCT02419872 | Completed

• 1 other identifier: BFS-AS-40087
• Study Type: observational
• Target: 1,743
• Locations: 10 countries
• Sites: 141

Brief Summary

The study is to evaluate the percentage of patients with asthma or COPD achieving disease control

Conditions

Asthma; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Percentage of patients whose respiratory disease is well controlled

  Questionnaires capture descriptive, qualitative responses

  1 Day

Secondary Outcomes (4)

• Patient Satisfaction Score

  1 Day

• Proportion of patients who comply with treatment according to Morisky Medication Adherence Scale (MMAS-8)

  1 Day

• Most Important Inhaler Features (MIIF) questionnaire

  1 Day

• Percentage of Participants with Adverse Events

  3 years

Study Arms (1)

Patient Participants

Patients are confirmed to have either Persistent Asthma or COPD

Drug: Marketed antagonists

Interventions

Marketed antagonists DRUG

Medication for each patient is determined by the physician based on the patient's individual clinical profile and in accordance with the approved indication and label of the prescribed drug

Also known as: as prescribed

Patient Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with asthma or COPD and on a stable dose of Inhaled corticosteroid (ICS)/Long-acting beta2-agonists (LABA) Fixed dose combination (FDC) administered by dry powder inhaler (DPI) twice daily for the previous 3 months

You may qualify if:

• Patient ≥ 18 years of age who has been diagnosed with persistent asthma or patient ≥ 40 years of age and/or (ex)-smoker with more than 10 pack years of smoking who has been diagnosed with COPD
• Treatment with a stable dose (no change in dose or change by less than 50% in the last 3 months) of a Inhaled corticosteroid (ICS), Long-acting beta2-agonists (LABA), Fixed dose combination (FDC) administered twice daily by Dry powder inhaler (DPI) for 3 months prior to enrollment in accordance with its approved indication
• Patient is willing and able to provide written informed consent;
• Patient agrees to participate in the study and to disclose any medical events to the treating physician;
• Patient is able to complete the questionnaires.

You may not qualify if:

• Current enrolment or planned enrolment in an interventional study (patients are allowed to participate in other observational or case-control studies).

Sponsors & Collaborators

• Teva Pharmaceuticals Europe: lead

Study Sites (141)

Teva Investigational Site 1011

Dubrovnik, Croatia

Location

Teva Investigational Site 1001

Karlovac, Croatia

Location

Teva Investigational Site 1007

Karlovac, Croatia

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Teva Investigational Site 1015

Metković, Croatia

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Teva Investigational Site 1014

Pula, Croatia

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Teva Investigational Site 1012

Rijeka, Croatia

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Teva Investigational Site 1005

Samobor, Croatia

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Teva Investigational Site 1004

Sisak, Croatia

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Teva Investigational Site 1013

Varaždin, Croatia

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Teva Investigational Site 1006

Zadar, Croatia

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Teva Investigational Site 1002

Zagreb, Croatia

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Teva Investigational Site 1003

Zagreb, Croatia

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Teva Investigational Site 1008

Zagreb, Croatia

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Teva Investigational Site 201

Aalborg, Denmark

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Teva Investigational Site 202

Aarhus, Denmark

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Teva Investigational Site 207

Copenhagen, Denmark

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Teva Investigational Site 204

Hvidovre, Denmark

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Teva Investigational Site 205

Kolding, Denmark

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Teva Investigational Site 203

Næstved, Denmark

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Teva Investigational Site 206

Roskilde, Denmark

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Teva Investigational Site 905

Enniscorthy, Ireland

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Teva Investigational Site 904

Lifford, Ireland

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Teva Investigational Site 903

Mallow, Ireland

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Teva Investigational Site 901

Sligo, Ireland

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Teva Investigational Site 906

Tramore, Ireland

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Teva Investigational Site 902

Youghal, Ireland

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Teva Investigational Site 513

Ancona, Italy

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Teva Investigational Site 31

Bari, Italy

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Teva Investigational Site 512

Brescia, Italy

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Teva Investigational Site 502

Brindisi, Italy

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Teva Investigational Site 514

Catania, Italy

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Teva Investigational Site 9

Chieti, Italy

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Teva Investigational Site 22

Florence, Italy

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Teva Investigational Site 505

Foggia, Italy

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Teva Investigational Site 20

Genova, Italy

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Teva Investigational Site 30

Lecco, Italy

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Teva Investigational Site 509

Legnago, Italy

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Teva Investigational Site 3

Modena, Italy

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Teva Investigational Site 11

Napoli, Italy

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Teva Investigational Site 8

Napoli, Italy

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Teva Investigational Site 14

Orbassano, Italy

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Teva Investigational Site 508

Palermo, Italy

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Teva Investigational Site 516

Parma, Italy

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Teva Investigational Site 501

Pavia, Italy

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Teva Investigational Site 10

Perugia, Italy

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Teva Investigational Site 18

Pietra Ligure, Italy

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Teva Investigational Site 506

Pisa, Italy

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Teva Investigational Site 510

Pordenone, Italy

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Teva Investigational Site 503

Roma, Italy

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Teva Investigational Site 21

Sassari, Italy

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Teva Investigational Site 24

Scafati, Italy

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Teva Investigational Site 515

Sesto San Giovanni, Italy

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Teva Investigational Site 507

Siena, Italy

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Teva Investigational Site 4

Torino, Italy

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Teva Investigational Site 511

Verona, Italy

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Teva Investigational Site 606

Alkmaar, Netherlands

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Teva Investigational Site 604

Grubbenvorst, Netherlands

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Teva Investigational Site 601

Harderwijk, Netherlands

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Teva Investigational Site 602

Helmond, Netherlands

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Teva Investigational Site 607

Hoofddorp, Netherlands

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Teva Investigational Site 603

Hoorn, Netherlands

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Teva Investigational Site 605

Rotterdam, Netherlands

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Teva Investigational Site 302

Hamar, Norway

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Teva Investigational Site 303

Holter, Norway

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Teva Investigational Site 301

Oslo, Norway

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Teva Investigational Site 304

Oslo, Norway

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Teva Investigational Site 702

Aveiro, Portugal

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Teva Investigational Site 707

Barcelos, Portugal

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Teva Investigational Site 706

Braga, Portugal

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Teva Investigational Site 701

Covilha, Portugal

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Teva Investigational Site 703

Guimarães, Portugal

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Teva Investigational Site 705

Porto, Portugal

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Teva Investigational Site 704

Vila Nova de Gaia, Portugal

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Teva Investigational Site 119

A Coruña, Spain

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Teva Investigational Site ES044

A Coruña, Spain

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Teva Investigational Site 113

Alcorcón, Spain

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Teva Investigational Site ES048

Alcorcón, Spain

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Teva Investigational Site 101

Barcelona, Spain

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Teva Investigational Site 102

Barcelona, Spain

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Teva Investigational Site 132

Barcelona, Spain

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Teva Investigational Site 133

Cáceres, Spain

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Teva Investigational Site 114

Córdoba, Spain

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Teva Investigational Site 111

Jaén, Spain

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Teva Investigational Site 105

Laredo, Spain

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Teva Investigational Site 120

Lugo, Spain

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Teva Investigational Site 109

Madrid, Spain

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Teva Investigational Site 110

Madrid, Spain

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Teva Investigational Site 124

Madrid, Spain

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Teva Investigational Site 126

Madrid, Spain

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Teva Investigational Site 134

Madrid, Spain

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Teva Investigational Site 136

Madrid, Spain

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Teva Investigational Site 135

Manacor, Spain

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Teva Investigational Site 108

Málaga, Spain

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Teva Investigational Site 118

Málaga, Spain

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Teva Investigational Site 123

Málaga, Spain

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Teva Investigational Site ES049

Málaga, Spain

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Teva Investigational Site 128

Murcia, Spain

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Teva Investigational Site 103

Oviedo, Spain

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Teva Investigational Site 107

Pamplona, Spain

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Teva Investigational Site 130

Ponferrada, Spain

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Teva Investigational Site 131

Pontevedra, Spain

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Teva Investigational Site 139

Santa Cruz de Tenerife, Spain

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Teva Investigational Site 117

Santander, Spain

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Teva Investigational Site 106

Santiago de Compostela, Spain

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Teva Investigational Site 112

Seville, Spain

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Teva Investigational Site 122

Seville, Spain

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Teva Investigational Site 125

Seville, Spain

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Teva Investigational Site ES046

Seville, Spain

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Teva Investigational Site 129

Terrassa, Spain

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Teva Investigational Site 140

Teruel, Spain

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Teva Investigational Site 104

Valencia, Spain

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Teva Investigational Site 115

Valencia, Spain

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Teva Investigational Site 116

Valencia, Spain

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Teva Investigational Site 127

Valencia, Spain

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Teva Investigational Site 121

Vic, Spain

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Teva Investigational Site 138

Zaragoza, Spain

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Teva Investigational Site 401

Lund, Sweden

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Teva Investigational Site 804

Atherstone, United Kingdom

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Teva Investigational Site 803

Beccles, United Kingdom

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Teva Investigational Site 813

Belfast, United Kingdom

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Teva Investigational Site 816

Birkenhead, United Kingdom

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Teva Investigational Site 815

Bolton, United Kingdom

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Teva Investigational Site 812

Bridgwater, United Kingdom

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Teva Investigational Site 807

Chippenham, United Kingdom

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Teva Investigational Site 817

Doncaster, United Kingdom

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Teva Investigational Site 811

Hinckley, United Kingdom

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Teva Investigational Site 801

Hitchin, United Kingdom

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Teva Investigational Site 821

Nantwich, United Kingdom

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Teva Investigational Site 824

Norwich, United Kingdom

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Teva Investigational Site 806

Portsmouth, United Kingdom

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Teva Investigational Site 808

Royal Leamington Spa, United Kingdom

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Teva Investigational Site 820

Sandbach, United Kingdom

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Teva Investigational Site 805

Thaxted, United Kingdom

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Teva Investigational Site 818

Thornton-Cleveleys, United Kingdom

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Teva Investigational Site 819

Tollerton, United Kingdom

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Teva Investigational Site 809

Trowbridge, United Kingdom

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Teva Investigational Site 802

Watford, United Kingdom

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Teva Investigational Site 822

Wells-next-the-Sea, United Kingdom

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Teva Investigational Site 810

Winchester, United Kingdom

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Teva Investigational Site 814

Wolverhampton, United Kingdom

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Teva Investigational Site 823

Wymondham, United Kingdom

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Teva Medical Expert, MD

  Teva Pharmaceuticals USA

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 17, 2015
• Study Start: May 31, 2015
• Primary Completion: April 7, 2017
• Study Completion: April 7, 2017
• Last Updated: November 7, 2017

Record last verified: 2017-11

Locations

IE (6); PT (7); IT (29); ES (43); DK (7); NO (4); NL (7); SE (1); GB (24); CR (13)