Salmeterol-Fluticasone Combined Inhaled Therapy for Non-cystic Fibrosis Bronchiectasis
BronchiectasisThe objective of this study is to assess the efficacy and safety of Salmeterol-Fluticasone (ICS and LABA)combined inhaled therapy for non-cystic fibrosis(non-CF)bronchiectasis patients with chronic airflow obstruction. Moreover, subgroup analysis is performed to explore which populations of bronchiectasis patients this treatment is suitable for.
Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis
Non-CF BronchiectasisThe purpose of this study is to evaluate the effect of tobramycin inhalation solution (TIS) once daily compared tot placebo in patients with non-CF bronchiectasis. The primary endpoint is a reduction of exacerbations of the disease during the treatment period. Next to this parameter the investigators expect to show a significant beneficial effect on lung function parameters, QoL, bacterial load of pathogens in sputum and tobramycin resistance.
Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)...
BronchiectasisThe purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.
Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)
Non Cystic Fibrosis BronchiectasisThis study (ARD-3150-1202, ORBIT-4) will evaluate the safety and efficacy of inhaled Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history of pulmonary exacerbations and chronic P. aeruginosa infections.
Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
BronchiectasisThe purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14 days over 48 weeks.
Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin by a Novel Device in Patients...
BronchiectasisBronchiectasis is a persistent and frequently progressive condition characterized by dilated and thick-walled bronchi retaining sputum. The main symptoms of bronchiectasis are cough and chronic sputum production. Until now, most patients with non-CF bronchiectasis receive inhaled tobramycin every other month, by use of a nebulizer. However, this delivery system has several disadvantages, like a low lung deposition and pollution with tobramycin in the surrounding environment. With an efficient dry powder inhaler (DPI), a three to six fold higher lung deposition compared to a nebulizer can be obtained. Therapy with a DPI is also less time consuming compared to nebulisation. We will investigate dry powder tobramycin (DP tobramycin) in a novel device in patients with non-CF bronchiectasis. The main objectives of this study are to investigate the pharmacokinetic properties of DP tobramycin at different dosages together with the local tolerability of DP tobramycin via the Cyclops® at different dosages.
Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant...
EmphysemaChronic Obstructive Pulmonary Disease (COPD)6 moreThe purpose of this research study is to learn about the safety of transplanting lungs obtained from non-heart-beating donors (NHBDs) that have been ventilated (attached to a breathing machine or ventilator to deliver oxygen) and perfused with a lung perfusion solution (Steen solution™, made by Vitrolife). This ventilation and perfusion will be done outside the body (ex-vivo) in a modified cardiopulmonary bypass circuit (the kind of device used routinely during most heart surgeries). The purpose of performing ex-vivo perfusion and ventilation is to learn how well the lungs work, and whether they are likely safe to transplant.
Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis
BronchiectasisThe purpose of this study is to find out if bacterial load in the airways can be reduced after inhalation of ciprofloxacin for 28 days.
Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis...
Non-Cystic Fibrosis BronchiectasisThe purpose of this study is to evaluate the safety and efficacy of Ciprofloxacin for Inhalation in the treatment of patients with non-cystic fibrosis (CF) bronchiectasis.
Bronchiectasis in Chronic Obstructive Pulmonary Disease (COPD) Patients: Role of Prophylaxis
BronchiectasisPulmonary Disease1 moreBronchiectasis is a chronic pulmonary disease characterized by an irreversible dilatation of the bronchi. The current view of the pathogenesis of bronchiectasis considers initial colonization of the lower respiratory tract by different microorganisms as the first step leading to an inflammatory response characterized by neutrophil migration within the airways and secondary secretion of a variety of tissue-damaging oxidants and enzymes such as neutrophil elastase and myeloperoxidase. Persistence of microorganisms in the airways because of impairment in mucus clearance may lead to a vicious circle of events characterized by chronic bacterial colonization, persistent inflammatory reaction, and progressive tissue damage. The exact prevalence of bronchiectasis in COPD patients is not known. It would be important to assess the prevalence, the kind of bronchiectasis and the bacterial colonisation. These are all important features that can be related to the natural history of COPD and to the therapeutic management of patient with COPD and bronchiectasis. Recent data indicate that macrolide long-term treatment and inhaled steroids therapy are both associated with a reduced rate of exacerbation, bronchial colonization and inflammation The present study will address, on a relatively large number of patients, the prevalence of bronchiectasis in COPD subjects using a multislice CT scan technique applied in all the units and centrally analysed by Unit 2 and 4. This analysis will determine the presence and the morphology of bronchiectasis. Bacterial colonization and inflammatory parameters will be evaluated on blood and exhalate bronchial condensate. Concerning bacterial colonization molecular biology techniques (Qualitative PCR and quantitative real time PCR) will be applied. ELISPOT technique for the evaluation of specific immune response will be used.Electron and optical microscopy techniques will be applied on bronchial biopsy samples obtained in a subgroup of patients enrolled. During the second study year, a randomized trial on patients with bronchiectasis will be performed. Patients will be randomized to receive a macrolide or inhaled steroids or standard of care for 6 months with a follow-up of 6 months. All the inflammatory, microbiologic and functional parameters described above will be recorded. A clinical and functional evaluation will be applied looking to number of exacerbations, quality of life, respiratory function parameters.