Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo
BronchiectasisPulmonary Disease1 moreThe rationale of this study is to conduct a summative (i.e., validation) usability test of Ciprofloxacin Dry Powder for Inhalation (DPI) and the associated Instructions for Use.
A Pilot Study to Investigate Administration of Mannitol Via a Novel Dry Powder Inhaler Device
HealthyBronchiectasisA novel dry powder inhaler device will be used to administer mannitol to healthy subjects and subjects with bronchiectasis in single doses higher than previously given.The main objective is to assess tolerability of these doses using the new device.
The Efficacy of Azithromycin in Treating Children With Non Cystic Fibrosis Bronchiectasis
Non Cystic Fibrosis Bronchiectasis in ChildrenBronchiectasis is characterized by a permanent and abnormal dilatation of a part of the bronchial tree. An accumulation of mucus in the respiratory tract ensues, resulting in frequent bacterial infections and eventual destruction of the lungs. Clinically, patients present with a chronic productive cough and episodes of acute respiratory exacerbations. Chronic respiratory failure can follow. Although its prevalence is largely unknown, bronchiectasis is considered to be a rare and orphan disease. There are numerous causes for this disease: sequelae of respiratory infections, immunodeficiency, genetic diseases like cystic fibrosis, primary ciliary dyskinesia….The focus of this study will be on non cystic fibrosis bronchiectasis in children. Due to a lack of pediatric clinical trials, the management of children with this disease is widely based on the management of adults or patients with cystic fibrosis or pan-bronchiolitis. The treatment is based on respiratory physiotherapy, prevention of infections, administration of inhaled corticosteroids and anti biotherapy for acute exacerbations. Recently, some studies have demonstrated the efficacy of a family of antibiotics, the macrolides, in the treatment of cystic fibrosis or pan-bronchiolitis in children. Indeed, taken 3 times a week during a long period of time, the macrolides, and specifically the azithromycin have shown some anti-inflammatory and tissue repairing properties, in addition to their antimicrobial properties. Moreover, several studies conducted in the adult population have shown that the use of azithromycin has led to significant reduction in the frequency of respiratory exacerbations as well as an improvement in the quality of life. The efficacy of azithromycin in these respiratory diseases has led to enlarge its use for the long term treatment of bronchiectasis. Yet, this type of treatment has no marketing authorization application. No studies have been conducted in children, but individual examination of patients with bronchiectasis treated with azithromycin suggests an improvement of their symptoms. Thus, the use of azithromycin in the treatment of bronchiectasis in children seems to be a promising therapy. However, its efficacy needs to be demonstrated by clinical trials led on a pediatric population with an adequate number of patients and a strong methodology in order to ensure validity and reliability of the results. Therefore the investigators decided to conduct a comparative, prospective multicenter randomized study in this population. This study intends to include 100 patients already treated by azithromycin for at least 6 months. After inclusion, they will be randomized in two groups of 50 patients each. The first group will continue the treatment and the other one will discontinue it. The patients will be followed from the inclusion period (M0) until the onset of the first exacerbation for a maximum of 6 months (M6), with an intermediate health care visit after 3 months (M3). In case of exacerbation, a health care visit will be scheduled; the patient will receive the appropriate treatment and he will be suspended from the study. The duration of follow up for each patient is dictated by the occurrence of the first respiratory exacerbation, a maximum of 6 months .The total inclusion period is 12 months and the total duration of the study is 18 months.
Autologous Transplantation of Bronchial Basal Cells for Treatment of Bronchiectasis
BronchiectasisBronchiectasis is a disease resulted from progressive destruction of bronchi with no effective drug for its treatment. In this study, we intends to carry out a single-centered, non-randomized and self-controlled clinical trial at an early phase. During the process, autologous bronchial basal cells (BBCs) will be dissected from trial tissue from bronchoscopic brushing. Then the BBCs will be expanded and detected by quality control. In the following, qualified BBCs will be injected directly into the lesion by fiberoptic bronchoscopy after lavage. After six-month observation, the investigators will evaluate the safety and effectiveness of the treatment by measuring a serial of indicators, including occurrence of adverse events, the CT imaging of dilated bronchi, pulmonary function, 6 minute walk distance (6MWD), the distance-saturation product (DSP), St. George's Respiratory Questionnaire (SGRQ), FACED scoring and bronchiectasis severity index (BSI) evaluation.
Inhalations of Ultra-low Doses of Melphalan for the Treatment of Non-cystic Fibrosis Bronchiectasis...
Non-cystic Fibrosis BronchiectasisThis non-randomised open-label prospective pilot study evaluates the safety and efficacy of inhalations of ultra-low doses of alkylating drug melphalan for the treatment of non-cystic fibrosis bronchiectasis. All patients will receive 0,1 mg of melphalan in 5 daily inhalations 1 time per day.
A Study to Access Safety and Efficacy of Nebulized Tobramycin in Patients With Bronchiectasis
BronchiectasisThis is a study to evaluate the efficacy,indications,adverse reactions and resistance of combined administration of nebulized tobramycin compared with systemic administration alone in patients with Bronchiectasis in acute exacerbation of Bronchiectasis.
Efficacy and Safety of An'Ningpai Expectorant in Non-CF Bronchiectasis
Bronchiectasis AdultThe objective of this study was to assess whether the long-term use of oral An'Ningpai Enteric Soft Capsuleson (300 mg, three times daily, 12 months) might reduce the incidence of exacerbations and improve the quality of life in patients with Non-CF bronchiectasis.
Effects of Traditional Chinese Medicine on Bronchiectasis Patients
BronchiectasisThe aim of this study is to evaluate the effectiveness of Traditional Chinese Medicine (TCM) on patients with clinically stable bronchiectasis by a multi-center, randomized, double-blind, controlled trial: one, TCM treatments based on syndrome differentiation; the other, a placebo of TCM treatment.
Different Phenotypes of Bronchiectasis
BronchiectasisBronchiectasis is defined as abnormal chronic dilatation of one or more bronchi. Patients have a structural abnormality of the bronchial wall that predisposes them to bacterial infection likely due to impaired mucus clearance. A vicious cycle of chest infections and chronic lung inflammation can lead to further damage of the bronchial wall and spread of disease to normal areas of bystander lung.
Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients With Acute Exacerbation...
BronchiectasisThe therapy of bronchoalveolar lavage and local amikacin injection as one of the treatment of bronchiectasis developed in recent years.this study is aim to evaluate the Clinical Efficacy and Safety of Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients with Acute Exacerbation of Bronchiectasis.