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

November 3, 2017 updated by: Teva Pharmaceuticals Europe

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1743

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patient Participants
Patients are confirmed to have either Persistent Asthma or COPD
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
Other Names:
  • as prescribed

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of patients whose respiratory disease is well controlled
Time Frame: 1 Day
Questionnaires capture descriptive, qualitative responses
1 Day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Satisfaction Score
Time Frame: 1 Day
A 10-point scale (where 1 = "not at all satisfied" and 10 = "extremely satisfied") is used to assess the patients' satisfaction
1 Day
Proportion of patients who comply with treatment according to Morisky Medication Adherence Scale (MMAS-8)
Time Frame: 1 Day
The 8-item MMAS-8 is a self-reported instrument to measure medication adherence
1 Day
Most Important Inhaler Features (MIIF) questionnaire
Time Frame: 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
1 Day
Percentage of Participants with Adverse Events
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teva Pharmaceuticals Europe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 31, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 7, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 7, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BFS-AS-40087

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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