The aim of the study is to evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and obstructive sleep apnea (OSA)
Background: The prevalence of obstructive sleep apnea (OSA) is high in patients with severe uncontrolled asthma and can worsen asthma control. Previous observational studies demonstrated that CPAP treatment could improve control in patients with mild-moderate asthma. Nevertheless, there are no studies in patients with severe uncontrolled asthma. Primary objective: To evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and OSA. Methodology: Multicenter, prospective, randomized, controlled clinical trial with parallel groups in subjects with severe uncontrolled asthma who are older than 18 years and without sleepiness (Epworth sleepiness scale score ≤10). All included subjects will undergo conventional polysomnography and those with an apnea-hypopnea index (AHI) ≥15/hour will be randomized in a 1:1 ratio to receive conservative treatment or conservative treatment plus CPAP. Monitoring will be carried out during12 months. Patients will be evaluated at inclusion, at 1 month, 6 and 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
138
Subjects allocated to this arm will receive continuous positive airway pressure (CPAP)
Subjects allocated to this arm will receive hygienic and dietary counselling
Hospital Clinic Barcelona
Barcelona, Spain, Spain
RECRUITINGAsthma control questionnaire
To evaluate the impact of CPAP treatment on asthma control based on the Asthma control questionnaire (ACQ)
Time frame: 12 months
Asthma control test
To evaluate the impact of CPAP treatment on asthma control based on the Asthma control test (ACT)
Time frame: 12 months
Lung function- forced expiratory volume in the first second (FEV1) in spirometry
To evaluate the impact of CPAP treatment on FEV1 (ml) on spirometry
Time frame: 12 months
Lung function-forced vital capacity (FVC) in spriometry
To evaluate the impact of CPAP treatment on FVC (ml) on spirometry
Time frame: 12 months
Prevalence of OSA in severe uncontrolled asthma
Determine the prevalence of OSA in patients with severe uncontrolled asthma
Time frame: Baseline
Inflammatory profile
Plasma proteins from peripheral blood samples will be used to analyze an inflammatory panel using a high-throughput, multiplex immunoassay technology based on Proximity Extension Assays (PEA) at baseline and after CPAP treatment
Time frame: Baseline, 6 and 12 months
Quality of life (Abbreviated Asthma Quality of life Questionnaire- mini-AQLQ questionnaire)
Study whether OSA ans its treatment affects quality of life in subjects with severe uncontrolled asthma based on the punctuation obtained in the mini-AQLQ questionnaire. Higher scores indicate better quality of life
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Time frame: 12 months
Exacerbations
Number of excarbations the year before starting the study and at 12-month of treatment in both arms
Time frame: From enrollment to the end of the study at 12 months