
The MONACO Cell Therapy Study: Monocytes as an Anti-fibrotic Treatment After COVID-19
Pulmonary FibrosisInterstitial Lung Disease1 moreUp to a third of patients who recovered from SARS coronavirus (SARS-CoV) had a 20% decline in lung function with a long term reduction in exercise capacity and SF-36 health status a year after infection. Similar outcomes are now being reported in COVID-19 patients, with interstitial lung disease (fibrosis) and long term lung function decline being a common feature. Anti-fibrotic monocytes/macrophages are important for the clearance of partially degraded collagen fragments of fibrotic extracellular matrix, in particular fibrillary-type collagen. MON002 is an autologous monocyte product, cultured in vitro prior to intravenous delivery into patients with post-COVID-19 lung fibrosis.

The Efficacy and Safety of Tocilizumab for Severe RP-ILD Secondary to Systemic Diseases
Rapid Progressive Interstitial Lung DiseasesThere is no confirmed drug therapy for RP-ILD. Prognosis is poor of regular treatment. The study is designed to compare efficacy and safety of tocilizumab versus regular treatment in participants with severe RP-ILD secondary to systemic diseases.

The Effects of Inhaled Budesonide-formoterol-glycopyrronium in Moderate-to-severe COPD
Pulmonary DiseaseChronic ObstructiveThe fixed-dose combination product Budesonide/Glycopyrronium/Formoterol Fumarate Inhalation Aerosol, BGF pMDI and dual combination product Glycopyrronium/Formoterol Fumarate Inhalation Aerosol , GFF pMDI are developed for maintenance treatment for patients with COPD. There are still some unmet medical needs and evidence gaps in COPD therapy, such as could BGF Inhalation Aerosphere reverse the disease progression such like airway-remodelling? Could BGF Inhalation Aerosphere reduce inflammation in small airways? Before differences proven between medication groups, pilot study is needed. This 52 weeks, Single-center, prospective, interventional pilot study could help discovering intervention effect of BGF and GFF on small airways through OCT measurement, which would show outcome of AEROSPHERE™ Delivery Technology on COPD patients.

Rehabilitation With HHFNC in COPD in Nocturnal NIV
Chronic Obstructive Pulmonary DiseaseHumidified High Flow Nasal Cannula (HHFNC), with optional supplemental oxygen delivery, has evolved in recent years with an increasing number of papers that show a better meet with respiratory demand, decrease oxygen dilution, increased Functional Residual Capacity (FRC), dead space washout, more tolerate than Non Invasive Ventilation (NIV) and provide heated and humidified gas. HHFNC is mainly used in intensive care settings or in acute respiratory diseases for the treatment of mild to moderate acute hypoxic respiratory failure and ventilator weaning. The aim of this study is to evaluate, in patients with Chronic Obstructive Pulmonary Disease (COPD) in nocturnal NIV, according to the European Respiratory Society (ERS) and American Thoracic Society (ATS) guidelines, whether HHFNC during rehabilitation has an additional effect in increasing the distance in 6 Minute Walking Distance (6MWD) compared to the control group with nocturnal NIV without HHFNC treatment. As secondary objectives, we expect a decrease in Emergency Department (ED) accesses, General Practitioner (GP) unplanned visits, hospitalizations and an improvement of the quality of life and patient satisfaction.

A Trial of Procalcitonin in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease...
ProcalcitoninChronic Obstructive Pulmonary DiseaseCurrent antibiotic prescription for patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is generally based on the Anthonisen criteria in The Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guideline, that has a potential risk of antibiotics overuse. The dilemma is to identify patients who are most likely to benefit from antibiotics while avoiding unnecessary antibiotic use. Procalcitonin (PCT), a more sensitive and specific biomarker of bacterial infection than other conventional laboratory tests, has the potential to determine those patients in whom antibiotics would be beneficial. It is unclear whether PCT-guided antibiotic therapy is safe and effective for inpatients with AECOPD. The investigators aim to conduct a 2-arm, multicenter randomized controlled trial in China to determine whether PCT-guided antibiotic therapy will reduce the antibiotic prescription rate for AECOPD without negatively impacting the treatment success rate, compared with the GOLD guideline antibiotic recommendations.

Iron and Chronic Obstructive Pulmonary Disease (COPD) Exercise Trial
Chronic Obstructive Pulmonary DiseaseThis phase II single centre, double blind, placebo-controlled, randomised trial aims to test the hypothesis that intravenous iron improves exercise performance in Chronic Obstructive Pulmonary Disease (COPD) as measured by constant rate cycle ergometry.

Non-invasive Positive Pressure (NPPV ) for Severe Stable Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary DiseaseHypercapnic Respiratory FailureAssessment of the effect and safety of noninvasive positive pressure ventilation for severe stable chronic obstructive pulmonary disease

Sustained Lung Inflation and Pulmonary Mechanics in Preterm Infant
Preterm BirthRespiratory Distress Syndrome1 moreLung protection should start in the delivery room where, from the first breaths, the preterm infant can be helped to clear the lung fluid and to recruit alveolar spaces and establish the functional residual capacity (FRC). Sustained lung inflation (SLI) applied at birth in the delivery room has been demonstrated to lead to clearance of lung fluid and achievement of a precocious functional residual capacity (FRC) both in animal and human studies. SLI associated to an adequate positive end expiratory pressure (PEEP) may help the efficacy of the respiratory effort in lung of preterm infants at risk for respiratory distress syndrome (RDS) and reduce need of mechanical ventilation (MV). Further studies are required to evaluate the clinical utility of this maneuver. The ability to monitor what happens to the lungs while applying different recruitment maneuvers in preterm infants would allow the definition of a procedure that allows optimal assistance to improve the FRC. One promising approach is provided by the forced oscillation technique (FOT). During forced oscillations, a small amplitude sinusoidal pressure stimulus is applied to the airway opening and the mechanical response of the respiratory system is studied by means of the total respiratory input impedance (Zin). Zin is a complex number that can be expressed as real part, called resistance (Rrs), and imaginary part, called reactance (Xrs). Particularly, it has been recently shown that Xrs measured at 5 Hz is very sensible to changes in the mechanics of lung periphery and provides accurate information about lung volume recruitment and derecruitment. The main purpose of this work is to apply FOT to the assessment of lung function in newborns submitted to SLI at birth. The investigators hypothesized that the application in the delivery room of the SLI in the preterm infant is effective in achieving a greater FRC and therefore a greater value of Xrs compared to a control group not treated with the SLI.

Pulmonary Gas Exchange Response to Indacaterol in COPD
Chronic Obstructive Pulmonary DiseaseTo evaluate the pulmonary gas exchange response to a therapeutic high dose of inhaled indacaterol (300 mcg) in 20 outpatients with stable symptomatic COPD B and D GOLD 2011 groups. Measurements on a single day before and after 60 and 120 minutes of indacaterol will include arterial PO2, PaCO2 and pH. AaPO2; SaO2 (by pulse oximetry) and oxygen and carbon dioxide in exhaled breath, systemic arterial pressure and heart rate will also be measured/calculated. Cardiac output will be directly measured by bio-impedance.

MSC for Treatment of Interstitial Lung Disease After Allo-HSCT
Lung DiseasesInterstitial2 moreInterstitial lung disease (ILD) is the late pulmonary complications after allogeneic hematopoietic stem cell transplantation (allo-HSCT) leading to high morbidity and mortality. At present, the treatment for ILD after allo-HSCT remains in discussion. In this study, the efficacy of mesenchymal stem cells (MSCs) combined azithromycin as well as glucocorticoid as the treatment of ILD will be evaluated in the recipients of allo-HSCT.