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Completed

NCT Number: NCT02187926

Evaluation of Clinical Effectiveness of Roflumilast in Routine Practice, in Chronic Obstructive Pulmonary Disease (COPD) Patients in Greece

The purpose of this study was to examine the characteristics of patients selected for treatment with roflumilast and the effectiveness and safety of roflumilast in patients with severe or very severe COPD treated in Hospital and outpatient specialist ward settings in Greece.

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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

40 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The drug being observed in this study is called roflumilast. Roflumilast is used to treat people who have chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis with a history of worsening symptoms. This study looked at side effects and the lung function of people who take roflumilast. The study enrolled 2577 patients who were already prescribed roflumilast as an add on to bronchiodilator treatment by their healthcare provider. This multi-centre trial was conducted in Greece. The overall time to participate in this study was up to 6 months. Participants were evaluated during routine appointments with their healthcare provider.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be diagnosed with COPD at stages 3 or 4 according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines.
  • Have the clinical phenotype of chronic bronchitis with cough and sputum production (with or without emphysema).
  • Already be receiving treatment for their disease (inhaled bronchodilators (long-acting beta2-agonists (LABA), long-acting muscarinic antagonists (LAMA), short-acting beta2-agonists (SABA), short-acting muscarinic antagonist (SAMA)), inhaled corticosteroids (ICS), combination of inhaled bronchodilators and corticosteroids.
  • Be aged over 40 years

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Change from Baseline in Forced Expiratory Volume in First Second (FEV1) at Month 6

    Time frame: Baseline and Month 6

    FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.

  2. Change From Baseline in Forced Vital Capacity (FVC) at Month 6

    Time frame: Baseline and Month 6

    Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.

  3. Change From Baseline in Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity (FEV1/FVC) at Month 6

    Time frame: Baseline and Month 6

    The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation.

Secondary outcomes

  1. Change from Baseline in Forced Expiratory Volume in First Second (FEV1) at Month 6

    Time frame: Baseline and Month 6

    FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.

  2. Percentage of Participants with Chronic Obstructive Pulmonary Disease (COPD) Exacerbations

    Time frame: Month 3 and Month 6

    A COPD exacerbation is an event characterised by a worsening in the patient's baseline dyspnoea, or cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management, and may be accompanied by increased wheeze, chest tightness, purulent sputum and symptoms of cold and/or fatigue.

  3. Percentage of Participants requiring Hospitalizations due to Exacerbations of COPD

    Time frame: Up to Month 6

  4. Change from Baseline in Clinical COPD Questionnaire (CCQ) Total Score

    Time frame: Baseline and Months 3 and 6

    Quality of life will be evaluated using the Clinical COPD Questionnaire (CCQ) 10-item questionnaire. The questions in the CCQ are divided into three area's, or domains: Symptoms: items 1, 2, 5 and 6; Functional state: items 7, 8, 9 and 10; Mental state: items 3 and 4. Individual items within the CCQ are equally weighted. The total score is calculated by adding the scores of the ten items and dividing that number by ten (= number of items). The total CCQ score, and the score on each of the three domains, varies between 0 (very good health status) to 6 (extremely poor health status).

  5. Change from Baseline in MRC Dyspnea Scale

    Time frame: Baseline and Months 3 and 6

    The Medical Research Council (MRC) breathlessness (dyspnea) scale comprises five statements that describe almost the entire range of respiratory disability: 1 - Not troubled by breathlessness except on strenuous exercise; 2 - Short of breath when hurrying or walking up a slight hill; 3 - Walks slower than contemporaries on level ground because of breathlessness, or has to stop for breath when walking at own pace; 4 - Stops for breath after walking about 100m or after a few minutes on level ground; 5 - Too breathless to leave the house, or breathless when dressing or undressing. The highest numbered question to which the subject answered 'Yes' is the Dyspnea Scale Score.

  6. Patient's Satisfaction with Roflumilast

    Time frame: Baseline and Months 3 and 6

    Is the perception of the participant according to the scale provided.

  7. Physician's Satisfaction with Roflumilast

    Time frame: Baseline and Months 3 and 6

    Is the perception of Physician taking into consideration the effectiveness and the tolerability of the drug.

  8. Change From Baseline in Forced Vital Capacity (FVC) at Month 3

    Time frame: Baseline and Month 3

    Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.

  9. Change From Baseline in Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity (FEV1/FVC) at Month 3

    Time frame: Baseline and Month 3

    The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation.

  10. Compliance to treatment

    Time frame: 6 months

    According to physician's judgment

  11. Number of participants with adverse drug reactions (ADR)

    Time frame: 6 months

    An ADR is any response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis or therapy of diseases or for the restoration, correction or modification of physiological function.

  12. Concomitant administration of inhaled bronchodilators and corticosteroids

    Time frame: 6 months

    Concomitant administration of inhaled bronchodilators and corticosteroids, either separately or in combination.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Observational Study for the Evaluation of Clinical Effectiveness in Routine Practice of Daxas® (Roflumilast), in Approximately 2700 Patients With Severe and Very Severe COPD (Chronic Obstructive Pulmonary Disease) in Greece

Acronym: ATLAS

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 11, 2014
Registry last updated
Dec 5, 2016

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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