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

Asthma Clinical Trial

— SPRINT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419872
• Other study ID #: BFS-AS-40087
• Status: Completed
• Phase: N/A
• First received: April 14, 2015
• Last updated: November 3, 2017
• Start date: May 31, 2015
• Est. completion date: April 7, 2017

Study information

• Verified date: November 2017
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 1743
• Est. completion date: April 7, 2017
• Est. primary completion date: April 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Marketed antagonists
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

Locations

Country	Name	City	State
Croatia	Teva Investigational Site 1011	Dubrovnik
Croatia	Teva Investigational Site 1001	Karlovac
Croatia	Teva Investigational Site 1007	Karlovac
Croatia	Teva Investigational Site 1015	Metkovic
Croatia	Teva Investigational Site 1014	Pula
Croatia	Teva Investigational Site 1012	Rijeka
Croatia	Teva Investigational Site 1005	Samobor
Croatia	Teva Investigational Site 1004	Sisak
Croatia	Teva Investigational Site 1013	Varazdin
Croatia	Teva Investigational Site 1006	Zadar
Croatia	Teva Investigational Site 1002	Zagreb
Croatia	Teva Investigational Site 1003	Zagreb
Croatia	Teva Investigational Site 1008	Zagreb
Denmark	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 203	Næstved
Denmark	Teva Investigational Site 206	Roskilde
Ireland	Teva Investigational Site 905	Enniscorthy
Ireland	Teva Investigational Site 904	Lifford
Ireland	Teva Investigational Site 903	Mallow
Ireland	Teva Investigational Site 901	Sligo
Ireland	Teva Investigational Site 906	Tramore
Ireland	Teva Investigational Site 902	Youghal
Italy	Teva Investigational Site 513	Ancona
Italy	Teva Investigational Site 31	Bari
Italy	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 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 10	Perugia
Italy	Teva Investigational Site 18	Pietra Ligure
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
Netherlands	Teva Investigational Site 606	Alkmaar
Netherlands	Teva Investigational Site 604	Grubbenvorst
Netherlands	Teva Investigational Site 601	Harderwijk
Netherlands	Teva Investigational Site 602	Helmond
Netherlands	Teva Investigational Site 607	Hoofddorp
Netherlands	Teva Investigational Site 603	Hoorn
Netherlands	Teva Investigational Site 605	Rotterdam
Norway	Teva Investigational Site 302	Hamar
Norway	Teva Investigational Site 303	Holter
Norway	Teva Investigational Site 301	Oslo
Norway	Teva Investigational Site 304	Oslo
Portugal	Teva Investigational Site 702	Aveiro
Portugal	Teva Investigational Site 707	Barcelos
Portugal	Teva Investigational Site 706	Braga
Portugal	Teva Investigational Site 701	Covilhã
Portugal	Teva Investigational Site 703	Guimarães
Portugal	Teva Investigational Site 705	Porto
Portugal	Teva Investigational Site 704	Vila Nova de Gaia
Spain	Teva Investigational Site 119	A Coruña
Spain	Teva Investigational Site ES044	A Coruña
Spain	Teva Investigational Site 113	Alcorcón
Spain	Teva Investigational Site ES048	Alcorcón
Spain	Teva Investigational Site 101	Barcelona
Spain	Teva Investigational Site 102	Barcelona
Spain	Teva Investigational Site 132	Barcelona
Spain	Teva Investigational Site 133	Cáceres
Spain	Teva Investigational Site 114	Córdoba
Spain	Teva Investigational Site 111	Jaén
Spain	Teva Investigational Site 105	Laredo
Spain	Teva Investigational Site 120	Lugo
Spain	Teva Investigational Site 109	Madrid
Spain	Teva Investigational Site 110	Madrid
Spain	Teva Investigational Site 124	Madrid
Spain	Teva Investigational Site 126	Madrid
Spain	Teva Investigational Site 134	Madrid
Spain	Teva Investigational Site 136	Madrid
Spain	Teva Investigational Site 108	Malaga
Spain	Teva Investigational Site ES049	Malaga
Spain	Teva Investigational Site 118	Málaga
Spain	Teva Investigational Site 123	Málaga
Spain	Teva Investigational Site 135	Manacor
Spain	Teva Investigational Site 128	Murcia
Spain	Teva Investigational Site 103	Oviedo
Spain	Teva Investigational Site 107	Pamplona
Spain	Teva Investigational Site 130	Ponferrada
Spain	Teva Investigational Site 131	Pontevedra
Spain	Teva Investigational Site 139	Santa Cruz de Tenerife
Spain	Teva Investigational Site 117	Santander
Spain	Teva Investigational Site 106	Santiago de Compostela
Spain	Teva Investigational Site 112	Sevilla
Spain	Teva Investigational Site 122	Sevilla
Spain	Teva Investigational Site 125	Sevilla
Spain	Teva Investigational Site ES046	Sevilla
Spain	Teva Investigational Site 129	Terrassa
Spain	Teva Investigational Site 140	Teruel
Spain	Teva Investigational Site 104	Valencia
Spain	Teva Investigational Site 115	Valencia
Spain	Teva Investigational Site 116	Valencia
Spain	Teva Investigational Site 127	Valencia
Spain	Teva Investigational Site 121	Vic
Spain	Teva Investigational Site 138	Zaragoza
Sweden	Teva Investigational Site 401	Lund
United Kingdom	Teva Investigational Site 804	Atherstone
United Kingdom	Teva Investigational Site 803	Beccles
United Kingdom	Teva Investigational Site 813	Belfast
United Kingdom	Teva Investigational Site 816	Birkenhead
United Kingdom	Teva Investigational Site 815	Bolton
United Kingdom	Teva Investigational Site 812	Bridgwater
United Kingdom	Teva Investigational Site 807	Chippenham
United Kingdom	Teva Investigational Site 817	Doncaster
United Kingdom	Teva Investigational Site 811	Hinckley
United Kingdom	Teva Investigational Site 801	Hitchin
United Kingdom	Teva Investigational Site 821	Nantwich
United Kingdom	Teva Investigational Site 824	Norwich
United Kingdom	Teva Investigational Site 806	Portsmouth
United Kingdom	Teva Investigational Site 808	Royal Leamington Spa
United Kingdom	Teva Investigational Site 820	Sandbach
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 802	Watford
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

Sponsors (1)

Lead Sponsor	Collaborator
Teva Pharmaceuticals Europe

Countries where clinical trial is conducted

Croatia,  Denmark,  Ireland,  Italy,  Netherlands,  Norway,  Portugal,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients whose respiratory disease is well controlled	Questionnaires capture descriptive, qualitative responses	1 Day
Secondary	Patient Satisfaction Score	A 10-point scale (where 1 = "not at all satisfied" and 10 = "extremely satisfied") is used to assess the patients' satisfaction	1 Day
Secondary	Proportion of patients who comply with treatment according to Morisky Medication Adherence Scale (MMAS-8)	The 8-item MMAS-8 is a self-reported instrument to measure medication adherence	1 Day
Secondary	Most Important Inhaler Features (MIIF) questionnaire	MIIF is a 10-point rating scale (where 1 = "not at all easy" and 10 = "extremely easy") for the 5 most important features	1 Day
Secondary	Percentage of Participants with Adverse Events		3 years