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OpenTrials
Completed

NCT Number: NCT02419872

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Teva Investigational Site 1011, Dubrovnik, Croatia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Marketed antagonists

Drug

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

Primary outcomes

  1. Percentage of patients whose respiratory disease is well controlled

    Time frame: 1 Day

    Questionnaires capture descriptive, qualitative responses

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Percentage of Participants with Adverse Events

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Teva Pharmaceuticals Europe

Industry

Registry information

Official study 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

Acronym: SPRINT

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 17, 2015
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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