JPRN-jRCT1052230157RecruitingPhase 3
Home High-Flow Therapy for Stable Bronchiectasis Patients: A Multicenter Randomized Crossover Trial - FLOBE
Tomii Keisuke0 sites30 target enrollmentStarted: December 26, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •1. Patients who include all the following (1)-(3)
- •(1) Meet the criteria about bronchiectasis diagnosis proposed by Aliberti (i, ii)
- •i) Meet the two conditions of the three following: coughing most of the week, developing phlegm most of the week, having a history of acute exacerbations
- •ii) Meet one or more conditions of the following on CT: bronchial inner diameter/bronchial artery diameter >= 1.0, bronchial outer diameter/bronchial artery diameter >= 1.0, lack of narrowing of the bronchial periphery, visual confirmation of the small airways
- •(2) Meet the criteria both i and ii as a clinical condition
- •i) CAT1[cough] >= 3 and CAT2[sputum] >= 3
- •ii) CAT total score >= 20
- •(3) Meet the criteria either i, ii, or iii as symptoms of respiratory failure
- •i) Arterial blood gas at rest; PaO2 < 70torr
- •ii) Arterial blood gas at rest; PaCO2 > 45torr
- •iii) Nocturnal hypoventilation
- •2. Age >= 18 years
- •3. Written informed consent provided
Exclusion Criteria
- •1. With uncontrolled kidney failure or cardiovascular failure
- •2. With malignant tumor
- •3. Having acute illness requiring treatment
- •4. With chronic respiratory illness as follows:
- •(1) Uncontrolled COPD
- •(2) Uncontrolled bronchial asthma
- •(3) Non-tuberculous mycobacterial pulmonary disease with sputum culture-mycobacteria positive or within 6 months before treatment
- •(4) Cystic fibrosis
- •(5) Obstructive sleep apnea syndrome
- •5. Current smoker or ex-smoker: smoking history pack-year>20
- •6. Exacerbation of bronchiectasis within 2 weeks
- •7. Changes in symptomatic treatment or rehabilitation within 4 weeks
- •8. Active airway breeding within 6 weeks
- •9. Treating with Noninvasive Positive Pressure Ventilation within 6 weeks
- •10. History of surgery to the chest and/or paranasal sinus
- •11. Pregnancy
- •12. Ineligible for the study judged by physicians due to dementia or mental illness
- •13. Ineligible for the study judged by physicians due to accompanying symptom
- •14. Participating in other studies
- •15. Difficulty using HFNC at home due to physical,mental, and social problems
- •16. Ineligible for the study judged by physicians due to some reasons
Investigators
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