Clinical trial NCT02187926: Evaluation of Clinical Effectiveness of Roflumilast in Routine Practice, in Chronic Obstructive Pulmonary Disease (COPD) Patients in Greece
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Drug therapy
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-07-11
Enrollment: 2577
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients prescribed roflumilast in Greece.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Forced Expiratory Volume in First Second (FEV1) at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Forced Vital Capacity (FVC) at Month 6
timeFrame: Baseline and Month 6
measure: Change From Baseline in Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity (FEV1/FVC) at Month 6
timeFrame: Baseline and Month 6
Secondary outcomes:
measure: Change from Baseline in Forced Expiratory Volume in First Second (FEV1) at Month 6
timeFrame: Baseline and Month 6
measure: Percentage of Participants with Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
timeFrame: Month 3 and Month 6
measure: Percentage of Participants requiring Hospitalizations due to Exacerbations of COPD
timeFrame: Up to Month 6
measure: Change from Baseline in Clinical COPD Questionnaire (CCQ) Total Score
timeFrame: Baseline and Months 3 and 6
measure: Change from Baseline in MRC Dyspnea Scale
timeFrame: Baseline and Months 3 and 6
measure: Patient's Satisfaction with Roflumilast
timeFrame: Baseline and Months 3 and 6
measure: Physician's Satisfaction with Roflumilast
timeFrame: Baseline and Months 3 and 6
measure: Change From Baseline in Forced Vital Capacity (FVC) at Month 3
timeFrame: Baseline and Month 3
measure: Change From Baseline in Ratio of Forced Expiratory Volume After 1 Second to Forced Vital Capacity (FEV1/FVC) at Month 3
timeFrame: Baseline and Month 3
measure: Compliance to treatment
timeFrame: 6 months
measure: Number of participants with adverse drug reactions (ADR)
timeFrame: 6 months
measure: Concomitant administration of inhaled bronchodilators and corticosteroids
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References: