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

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

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

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

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

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.

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).

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.

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

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

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

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

According to physician's judgment

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.

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