Skip to main content
OpenTrials
Completed

NCT Number: NCT02015767

Patient Registry of Roflumilast In Real Life

A patient registry to capture real life data and demonstrate the performance of roflumilast (Daxas®) in a standard clinical practice.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pleven, Bulgaria

Loading trial locations.

About this study

The drug being tested in this observational study design is called roflumilast, but not as an therapeutic intervention. Roflumilast is approved for and marketed globally for maintenance treatment of severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment.

This study will capture real life data and demonstrate the performance of roflumilast in a standard clinical practice. The study will enroll approximately 1350 (EU)+600(North Asia) patients. This multi-centre trial will be conducted in at least 4 EU and 2 North Asian countries.

The overall time to participate in this study is 12 months. No visits, diagnostic procedures or monitoring will take place, which would not happen had the patient not been included in the study.

Participants will be followed according to usual practice and data recorded approximately at 6 months and at 12 months of roflumilast treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed informed consent to the data collection
  • Roflumilast (Daxas®) treatment initiated in Roflumilast (Daxas®) naïve patients at the time of registry

Exclusion criteria

There are no exclusion criteria per se. However it is expected that patients are treated according to locally approved marketing authorisation.

Treatment and study plan

Primary outcomes

  1. Number of observed exacerbations

    Time frame: 12 months

    Number of exacerbations observed during the study period and per patient per year

Secondary outcomes

  1. Severity of exacerbations

    Time frame: 12 months

    Severity of exacerbations (proportion of exacerbations requiring systemic corticosteroid treatment and/or antibiotics or requiring hospitalization).

  2. Seasonal variation of exacerbation

    Time frame: 12 months

    Seasonal variation of exacerbation during Roflumilast treatment.

  3. Number of hospitalizations due to COPD exacerbations

    Time frame: 12 months

    Number of hospitalizations due to Chronic obstructive pulmonary disease (COPD) exacerbations per patient per year.

  4. Change from Baseline in lung function parameters (FEV1 and FEV1/FVC)

    Time frame: Baseline and Month 12

    Change in lung function parameters parameters FEV1(Forced Expired Volume measured after 1 second expiration) and FEV1/FVC (Forced Vital Capacity) from Baseline to the last recorded value and to the end of the study.

  5. Change from Baseline in blood oxygen saturation

    Time frame: Baseline and Month 12

    Change in blood oxygen saturation assessed with pulse oximetry from Baseline to the last recorded value and the end of the study.

  6. Percentage of compliance to treatment

    Time frame: 12 months

    Estimated percentage of prescribed doses taken since the last date of data collection.

  7. Changes in concomitant administration of COPD maintenance treatments

    Time frame: 12 months

    Changes in concomitant administration of COPD maintenance treatments since start of roflumilast treatment.

  8. Health status using the COPD Assessment Questionnaire (CAT)

    Time frame: Baseline, Month 6 and Month 12

  9. Change from Baseline in breathlessness

    Time frame: Baseline and Month 12

    Change in breathlessness assessed using the Modified Medical Research Council (mMRC) dyspnoea scale, from Baseline to the end of observation.

  10. Number of Participants with adverse Drug Reactions (ADRs)

    Time frame: 12 months

    An ADR is a response to an observed medicinal product which is noxious and unintended resulting not only from the authorised use of a medicinal product at normal doses, but also from medication errors and uses outside the terms of the marketing authorisation, including the misuse and abuse of the medicinal product.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 19, 2013
Registry last updated
Jun 23, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.