Clinical & Systems Medicine Investigations of Smoking-related Chronic Obstructive Pulmonary Disease...
Chronic Obstructive Pulmonary DiseaseEmphysema3 moreChronic Obstructive Pulmonary Disease (COPD) is an increasing global health problem, which primarily increases among the female population. The purpose of this study is to perform in-depth clinical and molecular characterizations of early stage COPD patients, as well as healthy never-smoker and at-risk smoking control populations to identify molecularly related subgroups patients, including gender-related sub-phenotypes of COPD.
Abituzumab in SSc-ILD
Systemic Sclerosis-associated Interstitial Lung DiseaseThe purpose of this trial was to compare two doses of abituzumab with placebo and determine whether abituzumab was more effective, safer, would be better tolerated and could provoke better immune response than placebo in the treatment of participants with SSc-ILD who already receive constant doses of mycophenolate.
Monitoring Response to Orkambi in Cystic Fibrosis Lung Disease by Inhaled Xenon MRI
Cystic FibrosisThis is an observational study for children with Cystic Fibrosis (CF) who are eligible based on their CF gene type. One group will be called the treatment group because they have the gene type (homozygous F508del) that makes them clinically eligible through their CF care provider to begin treatment with the new FDA approved CF drug called orkambi. For the control group, children will be enrolled who have a similar CF gene type (heterozygous F508del) but are not eligible to be prescribed orkambi. The two groups will be followed for four visits over about 3 to 4 years to observe changes in the lungs. Methods to measure the changes in lung disease will include: MRI with non-FDA approved inhaled xenon gas to take detailed images of the lungs, Pulmonary Function Tests (PFT), Lung Clearance Index (LCI), Baseline CT image of the lungs if not ordered as part of usual clinical care. The first two visits will be done before starting clinical treatment with orkambi and will be a minimum of 28 days apart and up to 18 months. The third visit will be scheduled about 3 months after starting orkambi and the fourth visit about 18 months later. For the control group, the timing of visits will be similar to treatment group and visits may be scheduled around annual CF care visits.
A Population-based Investigation of Asthma in the Telemark Region of Norway
Obstructive Lung DiseasesRespiratory Symptoms1 moreRespiratory conditions impose an enormous burden on the individual and the society. According to the WHO World Health Report 2000, the top five respiratory diseases - including asthma and COPD - account for 17% of all deaths and 13% of all Disability-Adjusted Life Years (DALYs). Obstructive lung diseases are among the most common chronic diseases in working-aged populations affecting ~40 million individuals in Europe. The greatest economic burden of respiratory diseases on health services and lost production in the EU is due to COPD and asthma, at about €20 billion each for healthcare and €25 billion and €15 billion, respectively, for lost production. For Norway, there are no estimates of asthma prevalence for the country as a whole, but 80/1000 women and 55/1000 men used asthma medication in 2013 according to the national prescription register. Estimated annual deaths in Norway due to COPD were 4070 in 2015, which is 30% higher than for lung cancer. Unfortunately, a substantial proportion of patients are still difficult to treat. This underlines the need for better primary prevention and more knowledge regarding causes and exacerbating factors. Several risk factors for chronic respiratory diseases are identified, most important tobacco smoke, closely followed by air pollution and occupational exposure. However, according to recent reviews there is a lack of understanding regarding environmental risk factors and mechanisms of how these affect respiratory health, the importance of biological markers and comorbidity, and of socioeconomic risk factors. Moreover, there is a need for assessment of interactions between risk factors and between the individual and the environment. Telemark has a high proportion of craft- and industrial workers providing exposure contrasts. Furthermore, the use of medication against respiratory diseases and the rate of sick leave are higher in Telemark than elsewhere in Norway. Moreover, the county has a high rate of disability. There are previous studies from other parts of Norway, which have estimated the occurrence of respiratory diseases and provided valuable knowledge regarding some risk factors. However, these studies use crude measures of self-reported exposure and do not provide sufficient information on how to target intervention and implement effective prevention. In contrast to the Telemark study, these studies have not included register data or advanced modelling of environmental exposure.
ADVAIR DISKUS® (Fluticasone Propionate/Salmeterol) Inhaler Versus SEREVENT DISKUS® (Salmeterol)...
Pulmonary DiseaseChronic ObstructiveThis study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease). The study will last 12 weeks. At the end of 12 weeks of treatment, subjects will stop the study medicines for 2 weeks. The study will involve 6 visits to the clinic. Subjects who elect to undergo bronchoalveolar lavage (BAL) procedures will have 8 study visits. Subjects will give sputum, blood, and in some cases BAL samples. Subjects will have breathing tests and will complete diary cards during the study. All study medicines and examinations will be given at no cost to the study subjects. Both medicines used in this study have been approved by the US FDA.
IC14 Antibodies to Treat Individuals With Acute Lung Injury
Respiratory Distress SyndromeAdult1 moreThis is a phase II, randomized, double-blind, placebo-controlled, safety and efficacy study of a recombinant chimeric monoclonal antibody against CD14 (IC14) in hospitalized patients with acute lung injury (ALI).
Hospital-Based Program for Treatment of Severe Cardiopulmonary Disease With Inhaled Nitric Oxide...
Pulmonary HypertensionLung Disease3 moreThe purpose of this program is to evaluate the logistic issues and patient requirements for chronic pulsed INOmax delivery in ambulatory, home-care patients. To understand patient needs, patients with a variety of underlying diseases will be included. Safety of chronic therapy will be monitored by serial measurements of methemoglobin, platelet function assay and reported adverse events.
Molecular Epidemiology of ARDS
Acute Respiratory Distress SyndromeLung DiseasesTo examine the possible relationship between genetic factors and the acute respiratory distress syndrome (ARDS).
AirWaze - Easy and Advanced Tools for CBCT Guided Lung Interventions
Lung DiseasesThe goal of this clinical trial is to assess the overall usability of the Philips AirWaze investigational device in patients indicated for CBCT-guided navigation bronchoscopy procedure. The main questions it aims to answer are to assess the: overall usability of the device accuracy of the tool-in-lesion confirmation scan Participants will undergo bronchoscopy with the new navigation device and additional confirmation scans. Follow-up visit at 7days will be performed.
Defining a Technique for the Use of Cryogenic Catheters for Biopsy and Ablation for the Diagnostic...
Lung DiseasesDeveloping a standardized methodology for the use of novel cryogenic catheters for transbronchial cryobiopsy and cryoablation of pulmonary lesions.