Study in Patients' With Persistent Asthma and Chronic Obstructive Pulmonary Disease
- Conditions
- AsthmaChronic Obstructive Pulmonary Disease
- Interventions
- Drug: Marketed antagonists
- Registration Number
- NCT02419872
- Lead Sponsor
- Teva Pharmaceuticals Europe
- Brief Summary
The study is to evaluate the percentage of patients with asthma or COPD achieving disease control
- Detailed Description
There are no treatment groups or interventions to which the patients can be randomly assigned. Data will be collected in a routine setting on a single occasion during an otherwise normal visit at the physician's office or clinic. Participating physicians will not perform any medical procedures that are outside of their normal daily clinical practice. All treatment decisions are at the sole discretion of the participating physicians and reflect their current standard of care
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1743
- 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.
• Current enrolment or planned enrolment in an interventional study (patients are allowed to participate in other observational or case-control studies).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patient Participants Marketed antagonists Patients are confirmed to have either Persistent Asthma or COPD
- Primary Outcome Measures
Name Time Method Percentage of patients whose respiratory disease is well controlled 1 Day Questionnaires capture descriptive, qualitative responses
- Secondary Outcome Measures
Name Time Method Most Important Inhaler Features (MIIF) questionnaire 1 Day MIIF is a 10-point rating scale (where 1 = "not at all easy" and 10 = "extremely easy") for the 5 most important features
Patient Satisfaction Score 1 Day A 10-point scale (where 1 = "not at all satisfied" and 10 = "extremely satisfied") is used to assess the patients' satisfaction
Percentage of Participants with Adverse Events 3 years Proportion of patients who comply with treatment according to Morisky Medication Adherence Scale (MMAS-8) 1 Day The 8-item MMAS-8 is a self-reported instrument to measure medication adherence
Trial Locations
- Locations (141)
Teva Investigational Site 1013
🇭🇷Varazdin, Croatia
Teva Investigational Site 1004
🇭🇷Sisak, Croatia
Teva Investigational Site 1005
🇭🇷Samobor, Croatia
Teva Investigational Site 1003
🇭🇷Zagreb, Croatia
Teva Investigational Site 31
🇮🇹Bari, Italy
Teva Investigational Site 115
🇪🇸Valencia, Spain
Teva Investigational Site 821
🇬🇧Nantwich, United Kingdom
Teva Investigational Site 138
🇪🇸Zaragoza, Spain
Teva Investigational Site 127
🇪🇸Valencia, Spain
Teva Investigational Site 122
🇪🇸Sevilla, Spain
Teva Investigational Site 129
🇪🇸Terrassa, Spain
Teva Investigational Site 104
🇪🇸Valencia, Spain
Teva Investigational Site 401
🇸🇪Lund, Sweden
Teva Investigational Site 812
🇬🇧Bridgwater, United Kingdom
Teva Investigational Site 801
🇬🇧Hitchin, United Kingdom
Teva Investigational Site 802
🇬🇧Watford, United Kingdom
Teva Investigational Site ES046
🇪🇸Sevilla, Spain
Teva Investigational Site 131
🇪🇸Pontevedra, Spain
Teva Investigational Site 803
🇬🇧Beccles, United Kingdom
Teva Investigational Site 807
🇬🇧Chippenham, United Kingdom
Teva Investigational Site 106
🇪🇸Santiago de Compostela, Spain
Teva Investigational Site 824
🇬🇧Norwich, United Kingdom
Teva Investigational Site 117
🇪🇸Santander, Spain
Teva Investigational Site 820
🇬🇧Sandbach, United Kingdom
Teva Investigational Site 804
🇬🇧Atherstone, United Kingdom
Teva Investigational Site 139
🇪🇸Santa Cruz de Tenerife, Spain
Teva Investigational Site 813
🇬🇧Belfast, United Kingdom
Teva Investigational Site 815
🇬🇧Bolton, United Kingdom
Teva Investigational Site 811
🇬🇧Hinckley, United Kingdom
Teva Investigational Site 112
🇪🇸Sevilla, Spain
Teva Investigational Site 140
🇪🇸Teruel, Spain
Teva Investigational Site 203
🇩🇰Næstved, Denmark
Teva Investigational Site 513
🇮🇹Ancona, Italy
Teva Investigational Site 1007
🇭🇷Karlovac, Croatia
Teva Investigational Site 1015
🇭🇷Metkovic, Croatia
Teva Investigational Site 201
🇩🇰Aalborg, Denmark
Teva Investigational Site 202
🇩🇰Aarhus, Denmark
Teva Investigational Site 207
🇩🇰Copenhagen, Denmark
Teva Investigational Site 204
🇩🇰Hvidovre, Denmark
Teva Investigational Site 205
🇩🇰Kolding, Denmark
Teva Investigational Site 206
🇩🇰Roskilde, Denmark
Teva Investigational Site 904
🇮🇪Lifford, Ireland
Teva Investigational Site 903
🇮🇪Mallow, Ireland
Teva Investigational Site 901
🇮🇪Sligo, Ireland
Teva Investigational Site 512
🇮🇹Brescia, Italy
Teva Investigational Site 502
🇮🇹Brindisi, Italy
Teva Investigational Site 514
🇮🇹Catania, Italy
Teva Investigational Site 9
🇮🇹Chieti, Italy
Teva Investigational Site 22
🇮🇹Firenze, Italy
Teva Investigational Site 505
🇮🇹Foggia, Italy
Teva Investigational Site 20
🇮🇹Genova, Italy
Teva Investigational Site 30
🇮🇹Lecco, Italy
Teva Investigational Site 509
🇮🇹Legnago, Italy
Teva Investigational Site 3
🇮🇹Modena, Italy
Teva Investigational Site 11
🇮🇹Napoli, Italy
Teva Investigational Site 111
🇪🇸Jaén, Spain
Teva Investigational Site 8
🇮🇹Napoli, Italy
Teva Investigational Site 14
🇮🇹Orbassano, Italy
Teva Investigational Site 508
🇮🇹Palermo, Italy
Teva Investigational Site 516
🇮🇹Parma, Italy
Teva Investigational Site 501
🇮🇹Pavia, Italy
Teva Investigational Site 18
🇮🇹Pietra Ligure, Italy
Teva Investigational Site 10
🇮🇹Perugia, Italy
Teva Investigational Site 506
🇮🇹Pisa, Italy
Teva Investigational Site 510
🇮🇹Pordenone, Italy
Teva Investigational Site 503
🇮🇹Roma, Italy
Teva Investigational Site 21
🇮🇹Sassari, Italy
Teva Investigational Site 24
🇮🇹Scafati, Italy
Teva Investigational Site 515
🇮🇹Sesto San Giovanni, Italy
Teva Investigational Site 507
🇮🇹Siena, Italy
Teva Investigational Site 4
🇮🇹Torino, Italy
Teva Investigational Site 511
🇮🇹Verona, Italy
Teva Investigational Site 606
🇳🇱Alkmaar, Netherlands
Teva Investigational Site 601
🇳🇱Harderwijk, Netherlands
Teva Investigational Site 607
🇳🇱Hoofddorp, Netherlands
Teva Investigational Site 105
🇪🇸Laredo, Spain
Teva Investigational Site 302
🇳🇴Hamar, Norway
Teva Investigational Site 301
🇳🇴Oslo, Norway
Teva Investigational Site 702
🇵🇹Aveiro, Portugal
Teva Investigational Site 707
🇵🇹Barcelos, Portugal
Teva Investigational Site 706
🇵🇹Braga, Portugal
Teva Investigational Site 816
🇬🇧Birkenhead, United Kingdom
Teva Investigational Site 817
🇬🇧Doncaster, United Kingdom
Teva Investigational Site 806
🇬🇧Portsmouth, United Kingdom
Teva Investigational Site 808
🇬🇧Royal Leamington Spa, United Kingdom
Teva Investigational Site 805
🇬🇧Thaxted, United Kingdom
Teva Investigational Site 818
🇬🇧Thornton-Cleveleys, United Kingdom
Teva Investigational Site 819
🇬🇧Tollerton, United Kingdom
Teva Investigational Site 809
🇬🇧Trowbridge, United Kingdom
Teva Investigational Site 822
🇬🇧Wells Next the Sea, United Kingdom
Teva Investigational Site 810
🇬🇧Winchester, United Kingdom
Teva Investigational Site 814
🇬🇧Wolverhampton, United Kingdom
Teva Investigational Site 823
🇬🇧Wymondham, United Kingdom
Teva Investigational Site 704
🇵🇹Vila Nova de Gaia, Portugal
Teva Investigational Site ES044
🇪🇸A Coruña, Spain
Teva Investigational Site 102
🇪🇸Barcelona, Spain
Teva Investigational Site 132
🇪🇸Barcelona, Spain
Teva Investigational Site 133
🇪🇸Cáceres, Spain
Teva Investigational Site 120
🇪🇸Lugo, Spain
Teva Investigational Site 110
🇪🇸Madrid, Spain
Teva Investigational Site 134
🇪🇸Madrid, Spain
Teva Investigational Site 136
🇪🇸Madrid, Spain
Teva Investigational Site 108
🇪🇸Malaga, Spain
Teva Investigational Site 135
🇪🇸Manacor, Spain
Teva Investigational Site ES049
🇪🇸Malaga, Spain
Teva Investigational Site 128
🇪🇸Murcia, Spain
Teva Investigational Site 118
🇪🇸Málaga, Spain
Teva Investigational Site 123
🇪🇸Málaga, Spain
Teva Investigational Site 107
🇪🇸Pamplona, Spain
Teva Investigational Site 125
🇪🇸Sevilla, Spain
Teva Investigational Site 116
🇪🇸Valencia, Spain
Teva Investigational Site 121
🇪🇸Vic, Spain
Teva Investigational Site 1006
🇭🇷Zadar, Croatia
Teva Investigational Site 703
🇵🇹Guimarães, Portugal
Teva Investigational Site 905
🇮🇪Enniscorthy, Ireland
Teva Investigational Site 902
🇮🇪Youghal, Ireland
Teva Investigational Site 701
🇵🇹Covilhã, Portugal
Teva Investigational Site 1002
🇭🇷Zagreb, Croatia
Teva Investigational Site 1008
🇭🇷Zagreb, Croatia
Teva Investigational Site 906
🇮🇪Tramore, Ireland
Teva Investigational Site 1014
🇭🇷Pula, Croatia
Teva Investigational Site 605
🇳🇱Rotterdam, Netherlands
Teva Investigational Site 1011
🇭🇷Dubrovnik, Croatia
Teva Investigational Site 1001
🇭🇷Karlovac, Croatia
Teva Investigational Site 1012
🇭🇷Rijeka, Croatia
Teva Investigational Site 604
🇳🇱Grubbenvorst, Netherlands
Teva Investigational Site 603
🇳🇱Hoorn, Netherlands
Teva Investigational Site 602
🇳🇱Helmond, Netherlands
Teva Investigational Site 303
🇳🇴Holter, Norway
Teva Investigational Site 304
🇳🇴Oslo, Norway
Teva Investigational Site 705
🇵🇹Porto, Portugal
Teva Investigational Site 119
🇪🇸A Coruña, Spain
Teva Investigational Site 101
🇪🇸Barcelona, Spain
Teva Investigational Site 113
🇪🇸Alcorcón, Spain
Teva Investigational Site ES048
🇪🇸Alcorcón, Spain
Teva Investigational Site 114
🇪🇸Córdoba, Spain
Teva Investigational Site 103
🇪🇸Oviedo, Spain
Teva Investigational Site 124
🇪🇸Madrid, Spain
Teva Investigational Site 130
🇪🇸Ponferrada, Spain
Teva Investigational Site 126
🇪🇸Madrid, Spain
Teva Investigational Site 109
🇪🇸Madrid, Spain