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Home High-Flow Therapy for Stable Bronchiectasis Patients: A Multicenter Randomized Crossover Trial (FLOBE)

Home High-Flow Therapy for Stable Bronchiectasis Patients: A Multicenter Randomized Crossover Trial (FLOBE)

Tomii Keisuke

Kobe City Medical Center General Hospital

2-1-1 Minatojima-minamimachi, Chuo-ku Kobe, Hyogo

ktomii@kcho.jp

Hirabayashi Ryosuke

Kobe City Medical Center General Hospital

2-1-1 Minatojima-minamimachi, Chuo-ku Kobe, Hyogo

+81-78-302-4321

rhirabayashi0405@kcho.jp

Not Recruiting

Dec. 26, 2023

Interventional

randomized controlled trial

open(masking not used)

active control

crossover assignment

treatment purpose

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

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 intervention 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

Both

Bronchiectasis

Patients are randomly assigned by a centralized system in a 1:1 ratio to one of two open-label treatment groups:
(A group) For the first 6 weeks, patients get usual care and HFNC (High-Flow Nasal Cannula oxygen therapy). Next 6 weeks, they get only usual care.
(B group) For the first 6 weeks, patients get only usual care. Next 6 weeks, they get usual care and HFNC.

Total score for St. Georges Respiratory Questionnaire

1) Each component score for SGRQ (Symptom, Activity, Impact)
2) The number of times and days of hospitalization by exacerbations of symptoms in the first and next 6 weeks.
3) Total score for Quality of Life Bronchiectasis Questionnaire
4) Score for COPD assessment test
5) Respiratory function (FVC, FEV1, FEV1% etc.)
6) Arterial blood gas in the early morning: pH, PaCO2, PaO2, HCO3-, BE
7) 6-minute walk distance
8) Score for Leicester Cough Questionnaire
9) Sputum Symptoms: color scale, amount, the difficulty of phlegm expulsion (VAS scale), the score of image evaluation (Bhalla score, the number of mucous plug)
10) CRP

+81-78-302-5176

Sept. 27, 2023

No

none