Clinical trial NCT02419872: Study in Patients' With Persistent Asthma and Chronic Obstructive Pulmonary Disease
Official title: A Phase IV Real-World Multi-Country Observational Study on Patients' Disease Control and Self-Reported Outcomes During Fixed Dose Combination Inhaler Treatment for Persistent Asthma and COPD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Chronic Obstructive Pulmonary Disease
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2015-04-17
Enrollment: 1743
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Percentage of patients whose respiratory disease is well controlled
timeFrame: 1 Day
Secondary outcomes:
measure: Patient Satisfaction Score
timeFrame: 1 Day
measure: Proportion of patients who comply with treatment according to Morisky Medication Adherence Scale (MMAS-8)
timeFrame: 1 Day
measure: Most Important Inhaler Features (MIIF) questionnaire
timeFrame: 1 Day
measure: Percentage of Participants with Adverse Events
timeFrame: 3 years
Other outcomes:
Locations:
city: Dubrovnik
country: Croatia
facility: Teva Investigational Site 1011
city: Karlovac
country: Croatia
facility: Teva Investigational Site 1001
city: Karlovac
country: Croatia
facility: Teva Investigational Site 1007
city: Metkovic
country: Croatia
facility: Teva Investigational Site 1015
city: Pula
country: Croatia
facility: Teva Investigational Site 1014
city: Rijeka
country: Croatia
facility: Teva Investigational Site 1012
city: Samobor
country: Croatia
facility: Teva Investigational Site 1005
city: Sisak
country: Croatia
facility: Teva Investigational Site 1004
city: Varazdin
country: Croatia
facility: Teva Investigational Site 1013
city: Zadar
country: Croatia
facility: Teva Investigational Site 1006
city: Zagreb
country: Croatia
facility: Teva Investigational Site 1002
city: Zagreb
country: Croatia
facility: Teva Investigational Site 1003
city: Zagreb
country: Croatia
facility: Teva Investigational Site 1008
city: Aalborg
country: Denmark
facility: Teva Investigational Site 201
city: Aarhus
country: Denmark
facility: Teva Investigational Site 202
city: Copenhagen
country: Denmark
facility: Teva Investigational Site 207
city: Hvidovre
country: Denmark
facility: Teva Investigational Site 204
city: Kolding
country: Denmark
facility: Teva Investigational Site 205
city: Næstved
country: Denmark
facility: Teva Investigational Site 203
city: Roskilde
country: Denmark
facility: Teva Investigational Site 206
city: Enniscorthy
country: Ireland
facility: Teva Investigational Site 905
city: Lifford
country: Ireland
facility: Teva Investigational Site 904
city: Mallow
country: Ireland
facility: Teva Investigational Site 903
city: Sligo
country: Ireland
facility: Teva Investigational Site 901
city: Tramore
country: Ireland
facility: Teva Investigational Site 906
city: Youghal
country: Ireland
facility: Teva Investigational Site 902
city: Ancona
country: Italy
facility: Teva Investigational Site 513
city: Bari
country: Italy
facility: Teva Investigational Site 31
city: Brescia
country: Italy
facility: Teva Investigational Site 512
city: Brindisi
country: Italy
facility: Teva Investigational Site 502
city: Catania
country: Italy
facility: Teva Investigational Site 514
city: Chieti
country: Italy
facility: Teva Investigational Site 9
city: Firenze
country: Italy
facility: Teva Investigational Site 22
city: Foggia
country: Italy
facility: Teva Investigational Site 505
city: Genova
country: Italy
facility: Teva Investigational Site 20
city: Lecco
country: Italy
facility: Teva Investigational Site 30
city: Legnago
country: Italy
facility: Teva Investigational Site 509
city: Modena
country: Italy
facility: Teva Investigational Site 3
city: Napoli
country: Italy
facility: Teva Investigational Site 11
city: Napoli
country: Italy
facility: Teva Investigational Site 8
city: Orbassano
country: Italy
facility: Teva Investigational Site 14
city: Palermo
country: Italy
facility: Teva Investigational Site 508
city: Parma
country: Italy
facility: Teva Investigational Site 516
city: Pavia
country: Italy
facility: Teva Investigational Site 501
city: Perugia
country: Italy
facility: Teva Investigational Site 10
city: Pietra Ligure
country: Italy
facility: Teva Investigational Site 18
city: Pisa
country: Italy
facility: Teva Investigational Site 506
city: Pordenone
country: Italy
facility: Teva Investigational Site 510
city: Roma
country: Italy
facility: Teva Investigational Site 503
city: Sassari
country: Italy
facility: Teva Investigational Site 21
city: Scafati
country: Italy
facility: Teva Investigational Site 24
city: Sesto San Giovanni
country: Italy
facility: Teva Investigational Site 515
city: Siena
country: Italy
facility: Teva Investigational Site 507
city: Torino
country: Italy
facility: Teva Investigational Site 4
city: Verona
country: Italy
facility: Teva Investigational Site 511
city: Alkmaar
country: Netherlands
facility: Teva Investigational Site 606
city: Grubbenvorst
country: Netherlands
facility: Teva Investigational Site 604
city: Harderwijk
country: Netherlands
facility: Teva Investigational Site 601
city: Helmond
country: Netherlands
facility: Teva Investigational Site 602
city: Hoofddorp
country: Netherlands
facility: Teva Investigational Site 607
city: Hoorn
country: Netherlands
facility: Teva Investigational Site 603
city: Rotterdam
country: Netherlands
facility: Teva Investigational Site 605
city: Hamar
country: Norway
facility: Teva Investigational Site 302
city: Holter
country: Norway
facility: Teva Investigational Site 303
city: Oslo
country: Norway
facility: Teva Investigational Site 301
city: Oslo
country: Norway
facility: Teva Investigational Site 304
city: Aveiro
country: Portugal
facility: Teva Investigational Site 702
city: Barcelos
country: Portugal
facility: Teva Investigational Site 707
city: Braga
country: Portugal
facility: Teva Investigational Site 706
city: Covilhã
country: Portugal
facility: Teva Investigational Site 701
city: Guimarães
country: Portugal
facility: Teva Investigational Site 703
city: Porto
country: Portugal
facility: Teva Investigational Site 705
city: Vila Nova de Gaia
country: Portugal
facility: Teva Investigational Site 704
city: A Coruña
country: Spain
facility: Teva Investigational Site 119
city: A Coruña
country: Spain
facility: Teva Investigational Site ES044
city: Alcorcón
country: Spain
facility: Teva Investigational Site 113
city: Alcorcón
country: Spain
facility: Teva Investigational Site ES048
city: Barcelona
country: Spain
facility: Teva Investigational Site 101
city: Barcelona
country: Spain
facility: Teva Investigational Site 102
city: Barcelona
country: Spain
facility: Teva Investigational Site 132
city: Cáceres
country: Spain
facility: Teva Investigational Site 133
city: Córdoba
country: Spain
facility: Teva Investigational Site 114
city: Jaén
country: Spain
facility: Teva Investigational Site 111
city: Laredo
country: Spain
facility: Teva Investigational Site 105
city: Lugo
country: Spain
facility: Teva Investigational Site 120
city: Madrid
country: Spain
facility: Teva Investigational Site 109
city: Madrid
country: Spain
facility: Teva Investigational Site 110
city: Madrid
country: Spain
facility: Teva Investigational Site 124
city: Madrid
country: Spain
facility: Teva Investigational Site 126
city: Madrid
country: Spain
facility: Teva Investigational Site 134
city: Madrid
country: Spain
facility: Teva Investigational Site 136
city: Malaga
country: Spain
facility: Teva Investigational Site 108
city: Malaga
country: Spain
facility: Teva Investigational Site ES049
city: Manacor
country: Spain
facility: Teva Investigational Site 135
city: Murcia
country: Spain
facility: Teva Investigational Site 128
city: Málaga
country: Spain
facility: Teva Investigational Site 118
city: Málaga
country: Spain
facility: Teva Investigational Site 123
city: Oviedo
country: Spain
facility: Teva Investigational Site 103
city: Pamplona
country: Spain
facility: Teva Investigational Site 107
city: Ponferrada
country: Spain
facility: Teva Investigational Site 130
city: Pontevedra
country: Spain
facility: Teva Investigational Site 131
city: Santa Cruz de Tenerife
country: Spain
facility: Teva Investigational Site 139
city: Santander
country: Spain
facility: Teva Investigational Site 117
city: Santiago de Compostela
country: Spain
facility: Teva Investigational Site 106
city: Sevilla
country: Spain
facility: Teva Investigational Site 112
city: Sevilla
country: Spain
facility: Teva Investigational Site 122
city: Sevilla
country: Spain
facility: Teva Investigational Site 125
city: Sevilla
country: Spain
facility: Teva Investigational Site ES046
city: Terrassa
country: Spain
facility: Teva Investigational Site 129
city: Teruel
country: Spain
facility: Teva Investigational Site 140
city: Valencia
country: Spain
facility: Teva Investigational Site 104
city: Valencia
country: Spain
facility: Teva Investigational Site 115
city: Valencia
country: Spain
facility: Teva Investigational Site 116
city: Valencia
country: Spain
facility: Teva Investigational Site 127
city: Vic
country: Spain
facility: Teva Investigational Site 121
city: Zaragoza
country: Spain
facility: Teva Investigational Site 138
city: Lund
country: Sweden
facility: Teva Investigational Site 401
city: Atherstone
country: United Kingdom
facility: Teva Investigational Site 804
city: Beccles
country: United Kingdom
facility: Teva Investigational Site 803
city: Belfast
country: United Kingdom
facility: Teva Investigational Site 813
city: Birkenhead
country: United Kingdom
facility: Teva Investigational Site 816
city: Bolton
country: United Kingdom
facility: Teva Investigational Site 815
city: Bridgwater
country: United Kingdom
facility: Teva Investigational Site 812
city: Chippenham
country: United Kingdom
facility: Teva Investigational Site 807
city: Doncaster
country: United Kingdom
facility: Teva Investigational Site 817
city: Hinckley
country: United Kingdom
facility: Teva Investigational Site 811
city: Hitchin
country: United Kingdom
facility: Teva Investigational Site 801
city: Nantwich
country: United Kingdom
facility: Teva Investigational Site 821
city: Norwich
country: United Kingdom
facility: Teva Investigational Site 824
city: Portsmouth
country: United Kingdom
facility: Teva Investigational Site 806
city: Royal Leamington Spa
country: United Kingdom
facility: Teva Investigational Site 808
city: Sandbach
country: United Kingdom
facility: Teva Investigational Site 820
city: Thaxted
country: United Kingdom
facility: Teva Investigational Site 805
city: Thornton-Cleveleys
country: United Kingdom
facility: Teva Investigational Site 818
city: Tollerton
country: United Kingdom
facility: Teva Investigational Site 819
city: Trowbridge
country: United Kingdom
facility: Teva Investigational Site 809
city: Watford
country: United Kingdom
facility: Teva Investigational Site 802
city: Wells Next the Sea
country: United Kingdom
facility: Teva Investigational Site 822
city: Winchester
country: United Kingdom
facility: Teva Investigational Site 810
city: Wolverhampton
country: United Kingdom
facility: Teva Investigational Site 814
city: Wymondham
country: United Kingdom
facility: Teva Investigational Site 823
Study officials:
affiliation: Teva Pharmaceuticals USA
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: