Bronchiectasis
Conditions
Interventions
Experimental group:SIMEOX 3 times per week for 3 weeks, concurrent N-acetyl-L-cysteine (NAC) 0.6 g/tablet.
Observational group:N-acetyl-L-cysteine (NAC)0.6g
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: ? Age >18 years ? HRCT or thin layer CT diagnosis of bronchiectasis, in complication with chronic obstructive pulmonary disease, asthma, post-infection patients ? Stable period, defined as no significant changes in respiratory symptoms during day and at night for 4 consecutive weeks, and no acute exacerbation of bronchitis or acute upper respiratory tract infection occurred in 4 consecutive weeks ? High sputum volume, number of daily sputum coughs >10 times/d ? Able to correctly use SIMEOX airway clearance technology after guidance and can tolerate it; ? Sign informed consent
Exclusion criteria
Exclusion criteria: ? Patients with active tuberculosis or other respiratory infections ? Significant arrhythmia or hemodynamic instability ? Tracheotomy ? Inability to perform forced expiratory manoeuvres ? Cough and expectoration difficulty ? Recent episode of massive haemoptysis, defined as more than 100 ml per 24 hours ? Pneumothorax in the past six months ? Acute exacerbation ? In complication with other serious systemic diseases or mental abnormalities ? Smokers with a smoking index greater than 20 pack-years* *Smokers' smoking index (pack-years) was derived from an online smoking index calculator and recorded at the time of patient enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adherence rate to SIMEOX treatment (number of SIMEOX treatments performed/number of SIMEOX treatments planned) over 21 days of treatment.;Quality of life changes Bronchiectasis-Respiratory Symptoms Scale (QoL-B-RSS) scores between baseline and 21-day follow-up.;Occurrence rate during the entire study (3-month FU for Simeox group, 21-day FUfor control group) of acute symptom exacerbations such as pulmonary exacerbation,new moderate-to-severe hemoptysis or worsening of preexisting mild hemoptysis,pneumothorax (confirmed by imaging) and of new atelectasis or worsening of preexisting atelectasis (CT imaging analysis). ; | — |
Secondary
| Measure | Time frame |
|---|---|
| 24h sputum volume and sputum properties change;Vital signs (blood routine, liver and kidney function, ECG);serum CRP; serum cytokines;sputum microbiome analysis; respiratory function examination (FEV1, FVC, FEF 25-75);SIMEOX questionnaire (pain, fatigue);mucus plugging in bronchi/bronchioles (CT imaging analysis);pulmonary hyperinflation measured by air trapping zones (CT imaging analysis);Frequency and severity of bronchiectasis (CT imaging analysis);Leicester Cough Questionnaire (LCQ);Bronchiectasis Severity Index, BSI;St. George's Respiratory Questionnaire (SGRQ);Patient Global Impression of Severity (PGI-S) and IBS Patient GlobalImpression of Change (PGI-C);Work Productivity and Activity Impairment: General Health (WPAI-GH);Cough symptom score; | — |
Countries
China
Contacts
Public ContactSONG Yuanlin
Zhongshan Hospital, Fudan University
Outcome results
None listed