Active clinical trials for "Lung Diseases"

The purpose of this study is to compare to nasal and buccal oxygen administration in patients undergoing Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration .

This study is designed to test whether the Inflammacheck™ device is easy to use by healthcare professionals who would be using it in a clinic setting or in primary care. The data collected during this study will be used as part of the evidence needed to get the CE (Conformité Européenne) marking for the device. CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). CE marking is essential for any medical devices used in the UK or the EU.

The purpose of this study is to evaluate whether nocturnal breathing and sleep of patients with chronic obstructive pulmonary disease (COPD) are disturbed during a stay at moderate altitude.

Preference study: Genuair® (Pressair™) vs Breezhaler® (Neohaler™) inhalers in patients with COPD

The purpose of this study is to determine the important change in the Short Physical Performance Battery (SPPB) when used in patients with lung disease. The SPPB is a simple physical test that measures balance and the functioning of the legs. It has been widely used in healthy elderly populations and predicts hospital admission and the onset of disability. The SPPB has not previously been used in patients with lung disease, and it is not clear what change in this test is considered meaningful and worthwhile by patients or doctors (the minimal clinically important difference: MID). Knowing what the MID for the SPPB will allow researchers and doctors to evaluate the effectiveness of current and new treatments, and to detect improvement or deterioration in the condition of patients.

Objective: To characterize FeNO levels that may be indicative of eosinophilic airway inflammation in patients with chronic obstructive airways disease Number of participants: Approximately 200 subjects will be enrolled Reference product: NIOX MINO® Instrument (09-1100) Performance assessments: Fractional Exhaled Nitric Oxide (FeNO) Measurements will be performed according to the "Perform FeNO Measurement" guidelines on page 7 of the NIOX MINO® User Manual Safety assessments: The Investigator is responsible for the detection, reporting, and documentation of events meeting the definition of an Adverse Event (AE) and/or Serious Injuries as provided in this clinical investigation plan from the time that informed consent has been provided and during the study period Criteria for evaluations: This is an observational, pilot study and there are currently no plans for a formal statistical analysis. Information gained from this study may used to design subsequent studies in patients with chronic obstructive airways disease. Information collected will be summarized in a clinical study report but will not be subject to formal hypothesis testing

Chronic Obstructive Pulmonary Disease (COPD) is a prevalent disease. In the investigators country, underdiagnosis has been estimated in around 80% of subjects. Early detection is done mainly in primary care but due to actual situation new alternatives have been proposed to decrease underdiagnosis. This present study promote by a multidisciplinary research team (respiratory medicine, primary care, nurse and pharmacist) raise the objective of evaluate the effect of a COPD case finding program guide by spirometry in community-pharmacies. From the results of a pilot-study conducted in 13 community-pharmacies in Barcelona, in which the investigators showed the feasibility of spirometry in community-pharmacies for the early detection of COPD, the investigators have design a second phase to evaluate the effect of this strategy. 100 Barcelona's community-pharmacies during 6 months will select high risk customers and will conduct a spirometry in agreement with the design protocol. 3600 spirometries is the establish objective. Participants hospitals will train pharmacist in spirometry and also control spirometry quality daily by a telematic pathway. Spirometry results will be evaluate in terms of effect and costs. The investigators will also evaluate the impact of this program in the health system by numbers of subjects diagnosed and follow up in primary care.

Most patients with chronic lung disease underestimate their actual walking ability due to low confidence. To better understand the relationships between lung function, self-efficacy for walking (confidence in ability to walk a defined distance), actual walking ability for the same distance gait speed and physical activity level-PAL- (total energy expenditure/resting metabolic rate). Quality of life, self efficacy for activity questionnaires, physical activity level measurement, 4-meter gait speed and 6-minute walk distance will be measured.

Pneumonia remains an important cause of morbidity and mortality in older adults with obstructive lung disease. Risk factors for pneumonia, including episodes associated with a hospital admission, have been extensively characterized in clinical trials and observational studies of patients with COPD, and include older age, lower predicted FEV1 (<50%), prior COPD exacerbations, dyspnea , normal to low body mass index (<25), current smoking and certain co-morbid conditions (e.g. dementia). The use of inhaled corticosteroids (ICS) has also been identified, as associated with an increased risk of pneumonia in patients with COPD. The primary objective of this study is to estimate the magnitude of known risk factors and the outcomes of pneumonia requiring hospitalization and the potential effect modification of these risk factors by ICS use. The primary endpoints will be severe pneumonia, defined as community-acquired pneumonia (CAP) resulting in hospitalization and/or death and hospital-acquired pneumonia (HAP) diagnosed after two days in the hospital. As a secondary endpoint, CAP that did not result in hospitalization or death will be examined. As a secondary objective, we will describe characteristics for those patients who develop pneumonia requiring hospitalization compared to those with pneumonia not requiring admission. This study will use the General Practice Online Database (GOLD), formerly referred to as the General Practice research Database (GPRD), a primary care electronic medical record database. A new user cohort will be defined among patients with COPD who are 45 years and older in the United Kingdom. Patients will be considered a new user of ICS-containing medications if they had not received a prescription for an ICS-containing medication in the prior year. The comparator treatment group will be new users of long-acting bronchodilators (LABD), including long-acting beta-agonists (LABA) or long-acting antimuscarinics (LAMA). In the one year washout period, all new users could not have either ICS-containing medications or LABD. Prior to conducting the analysis, feasibility analyses will be conducted to evaluate of the number of pneumonia events and the number of new users separately to examine the available precision based on the study design. Patients will be followed from the date of their first eligible prescription (Cohort Entry Date) until the earliest of the following: date of study end point (first pneumonia event of interest), date of treatment end (up to 60-day gap allowed for each inhaler), date of transfer to a new practice, date of ICS initiation (among LABD new users), death or study end (end of available data). As part of the primary analysis, patients will be examined for their first severe pneumonia (severe CAP, HAP). As a secondary analysis, time to non-severe CAP will be examined. Incidence rates of the pneumonia outcomes will be calculated as the number of patients experiencing an event divided by the person-years at risk. Multivariable analysis will be performed using Cox proportional hazard model with adjustment for confounders and medication exposure. To adjust for differences confounding by severity due to differences in prescribing between ICS-containing medications and LABD, propensity scores (PS) will be utilized using inverse probability of treatment weighting (IPTW). The propensity score will be estimated to model the probability of a patient receiving ICS-containing medication prescription versus receiving a LABD prescription given a patient's observed set of baseline covariates. Effect modification (statistical interaction) will be evaluated based on available theory and include ICS medication use by known risk factors for pneumonia (BMI<21, BMI 21-24.9, BMI ≥25, age, GOLD stage III/IV, MRC dyspnea score ≥4, history of pneumonia diagnosis, current smoking status, social deprivation quartiles). Additional interactions may be evaluated. To test proportionality of the hazard functions, model diagnostics will be performed. To compare severe pneumonia with non-severe pneumonia in patients with COPD, characteristics of patients experiencing non-severe CAP vs. severe CAP or HAP will be tabulated. To assess differences between treatments, clinical and patient characteristics will be compared using the chi-square tests or Wilcoxon tests for categorical or continuous data, respectively. Severe CAP and HAP may be combined. Modeling of clinical and patient characteristics may be considered using logistic regression using CAP vs. severe CAP and then with severe CAP vs. HAP. Additional analysis or adjustments to the analytic or modeling strategy will be performed if the data warrants. A more detailed modeling strategy, including generation of the propensity scores and Cox modeling, will be created in a separate analysis plan. Adjustments to the a priori plan will be described in the final study report.

Weaning of mechanical ventilation (MV) is an essential part in management of patients with Chronic Obstructive Pulmonary Disease (COPD) when critically ill. The best strategy to be used has not been established. Objective: To compare the Spontaneous Breathing Trial (SBT) in Pressure Support Ventilation with SBT through "T" tube in weaning of MV in patients with COPD. Design: Randomized Clinical Trial. Methods: This study will include patients with COPD, admitted to the Intensive Care Unit of Hospital Nossa Senhora da Conceição, undergoing MV for at least 48 hours. When considered by the care team ready for SBT, they will be randomized to one of the following strategies: SBT in Pressure Support or SBT through "T" Tube. The primary endpoint of this study will be the reduction in the days spent on MV. Other outcomes measured will be mortality, extubation and success rate, time to weaning of MV, length of ICU stay and incidence of tracheostomy.