View clinical trials related to Lung Diseases, Obstructive.
Filter by:The study is a Phase 2 Study to establish the safety and efficacy of a drug called Ivacaftor (VX-770) in patients with chronic obstructive pulmonary disease (COPD), chronic bronchitis, and acquired CFTR dysfunction as detected by sweat chloride analysis. The design is a pilot, randomized (3:1, active:placebo), double-blind, placebo-controlled study. Approximately 40 subjects with COPD will be randomized.
The purpose of this study is to evaluate the dose-response of different doses of CHF 5259 pMDI on lung function and other clinical outcomes, to identify the optimal dose(s) in terms of benefit/ risk ratio for further development in the target subject population.
Chronic Obstructive Pulmonary Disease (COPD) is a common respiratory disease characterized by airflow limitation that is progressive and not fully reversible. Patients with acute exacerbation of COPD must be hospitalized, as for further increase in airway resistance, pulmonary alveolar excessive expansion, diaphragm fatigue and neural respiratory drive. In recent years, Pulmonary rehabilitation is recognized as a core component in the comprehensive management of COPD, EDP as a means of rehabilitation can alleviate diaphragmatic fatigue, improve ventilation function, reduce the neural respiratory drive in patients with COPD during hospitalization, but still lack of evidence based medicine. Surface EMGdi can accurately evaluate neural respiratory drive, its detection is non-invasive, simple and safety .Therefore,Neural respiratory drive by surface EMGdi can be used as an important index for evaluating the therapeutic efficacy of AECOPD patients during hospitalization. In the present study, about 40 patients with COPD will be recruited as research subjects .And the investigators aim to explore the effect of EDP on diaphragmatic function and neural respiratory drive in patient with AECOPD.Contrast analysis will be conducted to evaluate the effects of EDP on patients with AECOPD, which may provide a reasonable basis for the clinical application of EDP to AECOPD patients.
Pulmonary rehabilitation is recognized as a core component of the management of individuals with chronic obstructive respiratory disease, which has become first-line treatment besides drug therapy. However, in the current clinical evaluation system of pulmonary rehabilitation, there is still a lack of simple, objective index,which can be monitored at any time.Neural respiratory drive , as an important physiological index, is closely related to the symptoms and the severity of the disease. It may be a sensitive indicator to evaluate the effectiveness of pulmonary rehabilitation. Surface EMGdi can accurately evaluate neural respiratory drive , its detection is non-invasive, simple and safety . In recent years, with the development of signal detection and analysis technology, EMG recording is more stable, but as the related research samples were low, surface diaphragm EMG has not yet the establishment of standardization. Therefore, based on the previous work, the project was carried out in a multicenter randomized controlled study,in which the stable stage of COPD patients were included in different ways of pulmonary rehabilitation training, a comprehensive clinical assessment will be conducted before and after training. Compared with the traditional evaluation methods and standard esophageal diaphragmatic electromyography, surface EMGdi detect the changes of neural respiratory drive in patients with COPD,that can help to explore the application value of surface EMGdi in the assessment of chronic obstructive pulmonary disease with pulmonary rehabilitation, to provide a basis for the promotion of the diaphragm and the optimization of pulmonary rehabilitation program.
Some patients who have multiple long-term health conditions have significant challenges accessing needed services despite available primary care and social services resources. Patient navigation programs may help those with complex health conditions improve their care and outcomes and if delivered by community health navigators (CHNs) who have close community ties, these programs have the potential to reduce barriers to care and increase access to coordinated, person-centred care. The ENCOMPASS program aims to improve the care and health outcomes for high-risk patients by linking patients with chronic disease with a CHN to help them navigate the health system, facilitate communication between patients and providers, improve patients' understanding of their conditions and treatment plans, and support patients in their self-management. In Canada, patient navigation programs have not been well studied or broadly implemented in patients with chronic disease, making a comprehensive evaluation of ENCOMPASS important. This program has great potential to improve care for patients with chronic diseases in primary care.
Up to 90% of consulting Acute Exacerbation (AE) of COPD patients are prescribed an antibiotic(1). Rates of inappropriate antibiotic prescription percentage can be as high as 65%(2). Excessive use of antibiotics is correlated with higher prevalence of antimicrobial resistance(3). There are insufficient data regarding the overprescribing antibiotics in AECOPD in our country.Therefore the investigators aimed to investigate the patients factors that are associated with the prescription of antibiotic for inappropriate indication in AECOPD.This is an observational cross sectional study.Population: AECOPD patients with AB(antibiotic) prescription Exposure: Presence of patient factors, Comparison: Absence of Patient factors, Outcome: Prescription of antibiotic for inappropriate indication. Sampling: Consecutive patients presenting to pharmacy between Monday and Friday. Date between January 1 2017 to January 1 30 2019. Primary Outcome:Prescription of antibiotic for inappropriate indication according to Anthonisen criteria for AECOPD Anthonisen criteria:-Worsening of dyspnea - Increased sputum volume - Increased sputum purulent 3/3 →Type 1 or severe AE 2/3 →Type 2 or moderate AE 1/3 →Type 3 or mild AE AB indicated/useful in Type 1 or severe AE, and Type 2 or moderate AE if sputum is purulent The data will be obtained from the database. Exposure: Patient factors that lead to inappropriate antibiotic prescription (will be considered together in analysis due to confounding) FEV1% Age Current smoker Comorbidities (Charlson comorbidity index) having Frequent exacerbations (≥2 past year) Use of oral steroids Polypharmacy Quality control:Detailed MOP will be developed, A manual for protocol will be written and used to inform the pharmacist,Pharmacist will be trained; to speak to participants in a neutral manner for written informed consent for the security ID(identity) data of the patients,This study will not affect the time period of the participants to access his/her drug. The pharmacy will use the questionnaire within the time period planned. A checklist for exclusion criteria will be developed. A plan for missing data will be developed. Null hypothesis: Patient factors are not associated with the prescription of antibiotics for inappropriate indications in patients with AECOPD Alternative hypothesis: Patient factors are associated with the prescription of antibiotics for inappropriate indications in patients with AECOPD Analysis The data will be analysed using SPSS version 22.0 The investigators will compare exposure variables between inappropriate and appropriate prescription groups Continuous variables - t test or Mann Whitney Binary- chi square test The investigators will use logistic regression to measure the associations between patient factors and the outcome of prescription of antibiotics for inappropriate indication Sample size and power Sample size to estimate CI of 15% around 25 to 50% prevalence of inappropriate prescription with p=0.05 and Power 80% Expected proportion0,25 128 0,50 171 Sample size and power For logistic regression - estimate 30% prevalence (n=143), or about 42 events . The investigators also need 5-10 events for each variable in the model, so this provides sufficient power for 4 to 8 factors. Limitations This study will just determine an association not causality The investigators won't be able to determine if the participant is truthful to the pharmacist The history of participants will be assessed from hospitals e-database - potential for missing data. The Anthonisen criteria for identifying inappropriate AB for AECOPD are still debatable The investigators can not modify many of the patient factors, but may be able to identify patients at higher risk of inappropriate antibiotics Ethics The project will be submitted to the ethical committee of Dr. Suat Seren Chest Disease Hospital Oral and written informed consent will be obtained from all subjects The study will be conducted in accordance with "Good Clinical Practice Guideline" Relevance This study will be the first one to evaluate an association between patient factors and prescription of antibiotic for inappropriate indication in an outpatient clinic of patients with AECOPD in Turkey. Subsequent studies should evaluate physician factors prescription of antibiotic for inappropriate indication.
A study to assess the pharmacokinetics and safety of two doses of PT010 and a single dose of PT003 in healthy Chinese adult subjects
People with COPD have more air in their lungs than other people (this problem with high lung volumes is called "hyperinflation"). Unfortunately this is unhelpful as breathing at higher lung volumes requires more effort and contributes to breathlessness. When anyone exercises, they breathe more quickly. People with COPD have narrowed airways, which makes breathing out difficult. When they breathe more quickly they may not be able to breathe out fully before they need to take the next breath in. This means that the volume of air in their lungs tends to increase further during exercise, which makes breathing even more difficult. This problem is called "dynamic hyperinflation". Pulmonary rehabilitation is one of the most helpful interventions for people with COPD and most of the benefit gained is from exercise. Anything that helps people increase the amount of exercise they can perform should lead to further improvements. Non-invasive positive pressure ventilation is a method of supporting a person's normal breathing. The ventilator delivers a flow of air at low pressure as you breathe out, which helps patients to breathe out more completely. The device also detects when patients start to breathe in and delivers a stronger flow of air at a higher pressure, helping them to take a deeper breath in. Previous research studies have shown that when people with COPD use non-invasive ventilation during exercise they are able to exercise for longer and are less breathless. The purpose of this study is to assess whether a new portable non-invasive ventilation device, called the VitaBreath, helps people with COPD recover from breathlessness during the exercise breaks more quickly (by reducing "dynamic hyperinflation", described above) and to exercise for longer overall. The VitaBreath device is small and light, weighing 0.5 kilograms (just over one pound). It is handheld and battery powered.
Thirty-two subjects diagnosed with COPD were enrolled, received each study treatment and completed the follow-up assessments. During each of the four study periods, subjects were admitted to the clinic on Day -1 and housed overnight until after the last spirometry measurement. Serial pulmonary function tests were performed and PK (pharmacokinetics) samples collected up to 25 hours. Subjects were discharged from the clinic on Day 2 after evaluations.
This Pilot study evaluates the use of a new device called Inflammacheck and whether it can consistently measure hydrogen peroxide levels in exhaled breath condensate. It will also assess whether exhaled breath condensate hydrogen peroxide levels as measured by Inflammacheck can differentiate people with asthma and COPD from healthy individuals.