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

Chronic Obstructive Pulmonary Disease Clinical Trial

— ATLAS  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02187926
• Other study ID #: RO-2455-401-GR
• Status: Completed
• Phase: N/A
• First received: April 29, 2014
• Last updated: December 1, 2016
• Start date: May 2011
• Est. completion date: December 2013

Study information

• Verified date: September 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2577
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Forced Expiratory Volume in First Second (FEV1) at Month 6	FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.	Baseline and Month 6	No
Primary	Change From Baseline in Forced Vital Capacity (FVC) at Month 6	Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.	Baseline and Month 6	No
Primary	Change From Baseline in Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity (FEV1/FVC) at Month 6	The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation.	Baseline and Month 6	No
Secondary	Change from Baseline in Forced Expiratory Volume in First Second (FEV1) at Month 6	FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation.	Baseline and Month 6	No
Secondary	Percentage of Participants with Chronic Obstructive Pulmonary Disease (COPD) Exacerbations	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.	Month 3 and Month 6	No
Secondary	Percentage of Participants requiring Hospitalizations due to Exacerbations of COPD		Up to Month 6	No
Secondary	Change from Baseline in Clinical COPD Questionnaire (CCQ) Total Score	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).	Baseline and Months 3 and 6	No
Secondary	Change from Baseline in MRC Dyspnea Scale	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.	Baseline and Months 3 and 6	No
Secondary	Patient's Satisfaction with Roflumilast	Is the perception of the participant according to the scale provided.	Baseline and Months 3 and 6	No
Secondary	Physician's Satisfaction with Roflumilast	Is the perception of Physician taking into consideration the effectiveness and the tolerability of the drug.	Baseline and Months 3 and 6	No
Secondary	Change From Baseline in Forced Vital Capacity (FVC) at Month 3	Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.	Baseline and Month 3	No
Secondary	Change From Baseline in Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity (FEV1/FVC) at Month 3	The FEV1/FVC ratio represents the percentage of vital capacity expelled from the lungs during the first second of a forced exhalation.	Baseline and Month 3	No
Secondary	Compliance to treatment	According to physician's judgment	6 months	No
Secondary	Number of participants with adverse drug reactions (ADR)	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.	6 months	Yes
Secondary	Concomitant administration of inhaled bronchodilators and corticosteroids	Concomitant administration of inhaled bronchodilators and corticosteroids, either separately or in combination.	6 months	No