Status:
COMPLETED
The Effect of Beclomethasone/Formoterol in Extra-fine Formulation on Quality of Life and SAD in COPD Patients.
Lead Sponsor:
Alfredo Antonio Chetta
Collaborating Sponsors:
University of Parma
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Brief Summary
In patients with chronic obstructive pulmonary disease (COPD), small-airway dysfunction (SAD) is considered a key element and a functional consequence of the pathology. However, the exact role of SAD ...
Detailed Description
In recent years, there has been a growing interest in deepening the contribution of small airways (with a diameter \<2mm) to the clinical expression of Chronic Obstructive Pulmonary Disease (COPD). I...
Eligibility Criteria
Inclusion
- a documented diagnosis of COPD defined according to the guidelines of the American Thoracic Society (ATS) / European Respiratory Society (ERS);
- smokers or former smokers with a smoking history of at least 10 pack / years;
- subjects with a post-bronchodilator forced expiratory volume at the 1st second (FEV1)/ forced vital capacity (FVC) ratio of \< 0.7 and a FEV1 \<50% pred;
- subjects with a high impact of the COPD on their health status (CAT≥10);
- clinical history of at least 1 moderate exacerbation / year;
- COPD patients being treated with BDP/FF NEXThaler® 100/6 μg in extra-fine formulation no more than 1 (one) week before enrollment.
Exclusion
- an exacerbation in the four weeks prior to enrollment;
- other coexisting lung diseases (bronchial asthma, restrictive diseases or bronchiectasis) and severe co-morbidities associated with COPD, such as uncontrolled cardiovascular disease, pneumonia or cancer;
- pregnant patients;
- subjects unable to meet the criteria of acceptability and repeatability of pulmonary function tests, according to the ATS / ERS document
Key Trial Info
Start Date :
May 31 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 23 2019
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04421742
Start Date
May 31 2017
End Date
May 23 2019
Last Update
June 9 2020
Active Locations (1)
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1
Department of Medicine and Surgery, Respiratory Disease and Lung Function Unit, University of Parma, Italy
Parma, Italy, 43125