Tokyo, Aug. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062433) titled 'Clinical Utility of the Aerobika Oscillating Positive Expiratory Pressure Device for Airway Secretion Clearance in Patients with Asthma and Allergic Bronchopulmonary Mycosis (ABPM): A Prospective Observational Study' on Aug. 3.

Study Type: Observational

Primary Sponsor: Institute - National Hospital Organization Sagamihara National Hospital

Condition: Condition - Asthma and Allergic Bronchopulmonary Mycosis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to evaluate the effect of adjunctive Aerobika use on sputum symptoms, as assessed by the CASA-Q sputum domain, in patients with asthma and allergic bronchopulmonary mycosis (ABPM). Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 18 years-old = Gender - Male and Female Key inclusion criteria - Inclusion Criteria 1. Outpatients aged 18 years or older who have been receiving standard treatment for asthma or allergic bronchopulmonary mycosis (ABPM) at our institution. (The diagnosis of ABPM will be based on Reference 4.) 2. Patients who have not experienced an asthma exacerbation or recurrence of ABPM within 24 weeks prior to obtaining informed consent. 3. Patients whose treatment for the underlying disease has remained unchanged for at least 12 weeks prior to obtaining informed consent, whose disease condition is stable, and who continue to have chronic sputum symptoms. * Chronic sputum symptoms are defined as sputum symptoms persisting for at least 12 weeks as confirmed by interview. In addition, a CASA-Q sputum symptom domain score of 80 or less must have been confirmed on two occasions separated by at least 4 weeks during the screening period and at study entry. ** Rationale for the cutoff value of 80: In patients with severe asthma eligible for biologic therapy, 79% had a CASA-Q sputum symptom domain score of 80 or less, whereas only 42% had a score of 60 or less (Reference 6). To include a broader range of patients with asthma, a cutoff value of 80 was adopted in this study. 4. Patients who are considered by the treating physician to have no contraindication to continued use of Aerobika. 5. Patients who have provided written informed consent for the use of Aerobika. Key exclusion criteria - Exclusion Criteria 1. Patients who are unable to understand or properly use the Aerobika device. 2. Patients who have experienced an asthma exacerbation or recurrence of ABPM within the previous 24 weeks. 3. Patients currently using other airway clearance or sputum clearance devices. 4. Patients with comorbid conditions that may affect study assessments, including autoimmune diseases and heart failure. 5. Patients who are pregnant or have untreated pneumothorax, progressive hemoptysis, elevated intracranial pressure, hemodynamic instability, or other conditions in which Aerobika use may be inappropriate. 6. Patients deemed unsuitable for participation in the study by the principal investigator or sub-investigators. Target Size - 60

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 03 Month 25 Day Date of IRB - 2026 Year 03 Month 26 Day Anticipated trial start date - 2026 Year 07 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071453

Disclaimer: Curated by HT Syndication.