AzTrials
AzTrials

AsthmaSPRINTNCT02419872

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

An observational study of Asthma and Chronic Obstructive Pulmonary Disease, run by Teva Pharmaceuticals Europe at 141 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Asthma, Chronic Obstructive Pulmonary Disease
What is being tested?
Marketed antagonists
How many people
1,743 participants
Where
141 sitesin 10 countries
Study dates
31 May 2015to 7 Apr 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

141 sites in 10 countries.

141 sites in 10 countries

Spain43 sites

  • Teva Investigational Site 119

    A Coruña

  • Teva Investigational Site ES044

    A Coruña

  • Teva Investigational Site 113

    Alcorcón

  • Teva Investigational Site ES048

    Alcorcón

  • Teva Investigational Site 101

    Barcelona

  • Teva Investigational Site 102

    Barcelona

  • Teva Investigational Site 132

    Barcelona

  • Teva Investigational Site 133

    Cáceres

  • Teva Investigational Site 114

    Córdoba

  • Teva Investigational Site 111

    Jaén

  • Teva Investigational Site 105

    Laredo

  • Teva Investigational Site 120

    Lugo

  • Teva Investigational Site 109

    Madrid

  • Teva Investigational Site 110

    Madrid

  • Teva Investigational Site 124

    Madrid

  • Teva Investigational Site 126

    Madrid

  • Teva Investigational Site 134

    Madrid

  • Teva Investigational Site 136

    Madrid

  • Teva Investigational Site 108

    Málaga

  • Teva Investigational Site 118

    Málaga

  • Teva Investigational Site 123

    Málaga

  • Teva Investigational Site ES049

    Málaga

  • Teva Investigational Site 135

    Manacor

  • Teva Investigational Site 128

    Murcia

  • Teva Investigational Site 103

    Oviedo

  • Teva Investigational Site 107

    Pamplona

  • Teva Investigational Site 130

    Ponferrada

  • Teva Investigational Site 131

    Pontevedra

  • Teva Investigational Site 139

    Santa Cruz de Tenerife

  • Teva Investigational Site 117

    Santander

  • Teva Investigational Site 106

    Santiago de Compostela

  • Teva Investigational Site 112

    Seville

  • Teva Investigational Site 122

    Seville

  • Teva Investigational Site 125

    Seville

  • Teva Investigational Site ES046

    Seville

  • Teva Investigational Site 129

    Terrassa

  • Teva Investigational Site 140

    Teruel

  • Teva Investigational Site 104

    Valencia

  • Teva Investigational Site 115

    Valencia

  • Teva Investigational Site 116

    Valencia

  • Teva Investigational Site 127

    Valencia

  • Teva Investigational Site 121

    Vic

  • Teva Investigational Site 138

    Zaragoza

Other trials in Spain

Italy29 sites

  • Teva Investigational Site 513

    Ancona

  • Teva Investigational Site 31

    Bari

  • Teva Investigational Site 512

    Brescia

  • Teva Investigational Site 502

    Brindisi

  • Teva Investigational Site 514

    Catania

  • Teva Investigational Site 9

    Chieti

  • Teva Investigational Site 22

    Florence

  • Teva Investigational Site 505

    Foggia

  • Teva Investigational Site 20

    Genova

  • Teva Investigational Site 30

    Lecco

  • Teva Investigational Site 509

    Legnago

  • Teva Investigational Site 3

    Modena

  • Teva Investigational Site 11

    Naples

  • Teva Investigational Site 8

    Naples

  • Teva Investigational Site 14

    Orbassano

  • Teva Investigational Site 508

    Palermo

  • Teva Investigational Site 516

    Parma

  • Teva Investigational Site 501

    Pavia

  • Teva Investigational Site 10

    Perugia

  • Teva Investigational Site 18

    Pietra Ligure

  • Teva Investigational Site 506

    Pisa

  • Teva Investigational Site 510

    Pordenone

  • Teva Investigational Site 503

    Roma

  • Teva Investigational Site 21

    Sassari

  • Teva Investigational Site 24

    Scafati

  • Teva Investigational Site 515

    Sesto San Giovanni

  • Teva Investigational Site 507

    Siena

  • Teva Investigational Site 4

    Torino

  • Teva Investigational Site 511

    Verona

Other trials in Italy

United Kingdom24 sites

  • Teva Investigational Site 804

    Atherstone

  • Teva Investigational Site 803

    Beccles

  • Teva Investigational Site 813

    Belfast

  • Teva Investigational Site 816

    Birkenhead

  • Teva Investigational Site 815

    Bolton

  • Teva Investigational Site 812

    Bridgwater

  • Teva Investigational Site 807

    Chippenham

  • Teva Investigational Site 817

    Doncaster

  • Teva Investigational Site 811

    Hinckley

  • Teva Investigational Site 801

    Hitchin

  • Teva Investigational Site 821

    Nantwich

  • Teva Investigational Site 824

    Norwich

  • Teva Investigational Site 806

    Portsmouth

  • Teva Investigational Site 808

    Royal Leamington Spa

  • Teva Investigational Site 820

    Sandbach

  • Teva Investigational Site 805

    Thaxted

  • Teva Investigational Site 818

    Thornton-Cleveleys

  • Teva Investigational Site 819

    Tollerton

  • Teva Investigational Site 809

    Trowbridge

  • Teva Investigational Site 802

    Watford

  • Teva Investigational Site 822

    Wells-next-the-Sea

  • Teva Investigational Site 810

    Winchester

  • Teva Investigational Site 814

    Wolverhampton

  • Teva Investigational Site 823

    Wymondham

Other trials in United Kingdom

Croatia13 sites

  • Teva Investigational Site 1011

    Dubrovnik

  • Teva Investigational Site 1001

    Karlovac

  • Teva Investigational Site 1007

    Karlovac

  • Teva Investigational Site 1015

    Metković

  • Teva Investigational Site 1014

    Pula

  • Teva Investigational Site 1012

    Rijeka

  • Teva Investigational Site 1005

    Samobor

  • Teva Investigational Site 1004

    Sisak

  • Teva Investigational Site 1013

    Varaždin

  • Teva Investigational Site 1006

    Zadar

  • Teva Investigational Site 1002

    Zagreb

  • Teva Investigational Site 1003

    Zagreb

  • Teva Investigational Site 1008

    Zagreb

Other trials in Croatia

Denmark7 sites

  • Teva Investigational Site 201

    Aalborg

  • Teva Investigational Site 202

    Aarhus

  • Teva Investigational Site 207

    Copenhagen

  • Teva Investigational Site 204

    Hvidovre

  • Teva Investigational Site 205

    Kolding

  • Teva Investigational Site 203

    Næstved

  • Teva Investigational Site 206

    Roskilde

Other trials in Denmark

Netherlands7 sites

  • Teva Investigational Site 606

    Alkmaar

  • Teva Investigational Site 604

    Grubbenvorst

  • Teva Investigational Site 601

    Harderwijk

  • Teva Investigational Site 602

    Helmond

  • Teva Investigational Site 607

    Hoofddorp

  • Teva Investigational Site 603

    Hoorn

  • Teva Investigational Site 605

    Rotterdam

Other trials in Netherlands

Portugal7 sites

  • Teva Investigational Site 702

    Aveiro

  • Teva Investigational Site 707

    Barcelos

  • Teva Investigational Site 706

    Braga

  • Teva Investigational Site 701

    Covilha

  • Teva Investigational Site 703

    Guimarães

  • Teva Investigational Site 705

    Porto

  • Teva Investigational Site 704

    Vila Nova de Gaia

Other trials in Portugal

Ireland6 sites

  • Teva Investigational Site 905

    Enniscorthy

  • Teva Investigational Site 904

    Lifford

  • Teva Investigational Site 903

    Mallow

  • Teva Investigational Site 901

    Sligo

  • Teva Investigational Site 906

    Tramore

  • Teva Investigational Site 902

    Youghal

Other trials in Ireland

Norway4 sites

  • Teva Investigational Site 302

    Hamar

  • Teva Investigational Site 303

    Holter

  • Teva Investigational Site 301

    Oslo

  • Teva Investigational Site 304

    Oslo

Other trials in Norway

Sweden1 site

  • Teva Investigational Site 401

    Lund

Other trials in Sweden

About this study

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

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

Read the 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

Being tested
Marketed antagonists
Medical subject headings
Asthma, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Marketed antagonistsDrug

    Also called as prescribed

    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

Study groups in NCT02419872
Study groupRoleWhat they receive
Patient ParticipantsPatients are confirmed to have either Persistent Asthma or COPD
Receives: Drug: Marketed antagonists

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of patients whose respiratory disease is well controlled

    Questionnaires capture descriptive, qualitative responses

    Measured: 1 Day

Secondary outcomes (4)

  1. Patient Satisfaction Score

    A 10-point scale (where 1 = "not at all satisfied" and 10 = "extremely satisfied") is used to assess the patients' satisfaction

    Measured: 1 Day

  2. 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

    Measured: 1 Day

  3. 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

    Measured: 1 Day

  4. Percentage of Participants with Adverse Events

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Apr 2015 (estimated)
  2. Study start31 May 2015
  3. Primary completion7 Apr 2017
  4. Study completion7 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,743 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02419872
Sponsor's protocol ID
BFS-AS-40087
Acronym
SPRINT
Status last verified
Nov 2017
First submitted
14 Apr 2015
Last updated
7 Nov 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma and Chronic Obstructive Pulmonary Disease, run by Teva Pharmaceuticals Europe at 141 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 141 sites in Spain, Italy, United Kingdom, Croatia, Denmark and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of patients whose respiratory disease is well controlled (time frame: 1 Day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02419872.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in