Active clinical trials for "Lung Diseases"

Chronic obstructive pulmonary disease (COPD) is characterized by persistent respiratory symptoms (including breathlessness, cough, and sputum production), which has a substantial impact on health-related quality of life (HRQoL). Medical treatment of COPD aims to reduce these symptoms, reduce exacerbations, and improve patients' ability to perform exercise and daily activities. TRIXEO is a triple therapy indicated as a maintenance treatment in adult patients with moderate-to-severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist. The RECORD study is a prospective, non-interventional study to be conducted in the United Kingdom (UK) and Germany. The study aims to generate data to describe the real world effectiveness of TRIXEO for patients with COPD who receive TRIXEO in routine clinical practice. It also aims describe patients HRQoL, physical activity and treatment satisfaction, and will explore patients' sleep quality and adherence to inhalers in the real-world. This data may provide important information for practicing physicians. The study will include approximately 500 patients with moderate to severe COPD from approximately 50 sites (including hospitals and GP practices) in Germany. Patients eligible for TRIXEO therapy may be enrolled by their treating physicians. The decision to treat with TRIXEO must be independent of the study and made by the treating physician according to the patients' medical need and local routine clinical practice. Patients' data will be collected for 12 months after starting therapy with TRIXEO. Demographic and clinical data will be extracted from patients' health care records. Patient reported outcomes will be collected remotely by asking patients to answer questionnaires on health status and HRQoL, physical activity, sleep quality, treatment satisfaction, and inhaled medication adherence through electronic surveys.

The inflammation associated with COPD is characterized by a prominent infiltration of neutrophils in lung tissue and airways. The CXC chemokine receptor type 2 (CXCR2) plays a pivotal role in neutrophil recruitment to the lungs resulting in progressive fibrosis, airway stenosis, and destruction of the lung parenchyma characteristic of COPD. There is a paucity of novel therapies that target these symptoms, and there are no currently available therapies that modify disease progression in COPD. Danirixin (GSK1325756) is a selective CXCR2 antagonist being developed as a potential anti-inflammatory agent for the treatment of COPD and influenza. This study is a mechanistic study which aims to evaluate the effect of danirixin in reducing neutrophil extracellular traps (NETs) formation (or NETosis). Subjects will be randomized (3:1) to receive danirixin hydrobromide (HBr) 35 milligram (mg) orally twice daily or matching placebo for 14 days. Subjects may continue to use rescue medication(s) and inhaled COPD maintenance medication(s) during the study. The study will consist of a screening period of up to 30 days, a 2 week treatment period, and a 1-week follow-up visit via phone call. Approximately 50 subjects will be screened to obtain approximately 24 subjects to complete the study.

The objective of this exploratory study is to examine the utility of high resolution computed tomography (HRCT) to measure changes in functional pulmonary imaging parameters as a function of long term iNO administrationusing the device INOpulse for 4 weeks in relation to Patient Reported Outcome (PRO) and exercise tolerance in subjects with WHO Group 3 PH associated with COPD on LTOT. Changes from baseline to 4 weeks of pulsed iNO and after 2 weeks of withdrawal from pulsed iNO will be evaluated.

This is a pilot study to investigate the effect of danirixin hydrobromide 35 milligram (mg) tablets on lung function and health related quality of life (HRQoL) in subjects with mild to moderate airflow obstruction and a demonstrated history of decline in forced expiratory volume in one second (FEV1). Specifically, this study aims to assess whether or not danirixin has the potential to impact disease progression in subjects with a COPD progression score indicating they are likely to decline based on 5 year data from a COPDGene study and support the conduct of a larger Phase III study for disease progression. Subjects will receive either placebo or danirixin 35 mg tablets (as hydrobromide hemihydrate salt) twice daily for 52 weeks (12months). Study subjects will continue with their standard of care inhaled medications (i.e. long acting bronchodilators with or without inhaled corticosteroids) while receiving study treatment. This study will be an ancillary study within the COPDGene study investigating the enrichment strategy for assessing disease progression. Potential subjects most likely to decline from the well established COPDGene cohort, will be based on data collected over the initial 5 year period. With the use of an enriched population, it is anticipated that one year of treatment will be sufficient to detect a trend in altering disease progression. Approximately 130 subjects will be screened to enroll 100 subjects in this study. The data from this study will provide useful information in determining whether to progress to a Phase III study to explore an indication for slowing disease progression.

This study examines the potential benefit of a new antibiotic, Solithromycin, for the long-term treatment of Chronic Obstructive Pulmonary Disease (COPD). Solithromycin is hypothesised to work by reducing inflammation in the lungs of patients with COPD. Stable COPD patients will receive treatment with solithromycin for 28 days and comparisons will be made between any effects observed with Solithromycin and a placebo. This will include any changes in inflammatory proteins, lung function and reported symptoms.

Respiratory 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.

Study to evaluate the safety of combivent delivered in two different formulations (hydrofluoroalkane (HFA) or chlorofluorocarbon (CFC)) from a metered dose inhaler (MDI), using a cumulative dose response model in patients with COPD.

The 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.

Chronic 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.

This 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.