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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 AOS.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative treatment | Active Comparator | Subjects allocated to this arm will receive hygienic and dietary measures counselling |
|
| CPAP treatment | Experimental | Subjects allocated to this arm will receive treatment with continuous positive airway pressure (CPAP) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP treatment | Device | Subjects allocated to this arm will receive continuous positive airway pressure (CPAP) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Asthma control questionnaire | To evaluate the impact of CPAP treatment on asthma control based on the Asthma control questionnaire (ACQ) | 12 months |
| Asthma control test | To evaluate the impact of CPAP treatment on asthma control based on the Asthma control test (ACT) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function- forced expiratory volume in the first second (FEV1) in spirometry | To evaluate the impact of CPAP treatment on FEV1 (ml) on spirometry | 12 months |
| Lung function-forced vital capacity (FVC) in spriometry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mireia Dalmases, MD | Contact | +34932275746 | mdalmase@clinic.cat |
| Name | Affiliation | Role |
|---|---|---|
| Mireia Dalmases, MD | Hospital Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic Barcelona | Recruiting | Barcelona | Spain | 08036 | Spain |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| D015596 | Nutrition Assessment |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| Hygienic and dietary advice | Other | Subjects allocated to this arm will receive hygienic and dietary counselling |
|
To evaluate the impact of CPAP treatment on FVC (ml) on spirometry
| 12 months |
| Prevalence of OSA in severe uncontrolled asthma | Determine the prevalence of OSA in patients with severe uncontrolled asthma | 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 | Baseline 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 | 12 months |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012138 |
| Respiratory Therapy |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |