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236 active trials for COPD

Multidisciplinary Management of Severe COPD

Chronic Obstructive Pulmonary Disease (COPD) is a common chronic disease that is characterized by persistent airflow limitation, that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases, particularly cigarette smoking. Latest updates of the Global Burden of Disease emphasize the dramatic size of the problem. In 2015, 3,2 million people died from COPD worldwide, an increase of 11,6% compared with 1990. The overall prevalence of COPD increased by 44,2% and was associated with a significant increase of disability-adjusted life years. In Sweden the prevalence of COPD is approximately 8% bringing the annual total estimated cost for society of 9.1 billion SEK. About 1/3 of patients with COPD undergo periods of acute worsening of respiratory symptoms, particularly dyspnea. Acute worsening of respiratory symptoms is associated with increased in-hospital mortality (up to 20%), short term- (up to 60% at 1 year) and long-term mortality (> 50% at 5 years) and high risk of re-hospitalization. Because patients with COPD often suffer concomitant disorders that significantly worsen their health status and vital prognosis, the management of the patients is not only the management of COPD but must include identification and treatment of other concomitant chronic diseases. Accurate diagnosis, assessment of severity, and long-term interdisciplinary management of both COPD and concomitant chronic diseases in patients with COPD could be associated with a decreased number of hospitalizations and deaths, improved quality of life and decreased health care utilization in the following 3 years. This longitudinal study will evaluate the effectiveness of detailed phenotyping and comprehensive multidisciplinary management of COPD and multimorbidity in patients. This is a prospective, open label, cohort study using design of intervention and registries data. The anticipated study time is 5 years, with 3 years of intervention (including 2 years of recruitment period) and 1-year data collection from the National Registries. The study will compare number of rehospitalizations from all causes of patient recruited after a hospitalization due to acute exacerbations of COPD to control patients included from the Swedish Airway Register (SAR). The selection of the control population within the SAR is based on risk score matching. At the first visit a thorough individual's assessment will be performed. The assessment includes information about demographics, COPD and exacerbations, medical history, comorbidities, vital parameters, blood and sputum tests and assessment of quality of life. Based on the outcome from the assessment and disease phenotype, personalized care plans will be prepared and given to the patients, including dietary program, adjusted exercise program, psychological counselling, treatment of comorbidities etc. Patients will come for planned follow-up visits, according to the protocol. The last visit will take place at 5th year after the study start. The "end of study" is defined as last visit of the last subject or if the effectiveness of the intervention is shown before. Data collected at eCRFs will be combined with the data from SAR and complemented with data from Swedish National Registries.

Start: May 2021
Effect of Muscle Energy Technique on Clinical and Functional Levels in Chronic Obstructive Pulmonary

The primary aim of this study is to examine the effect on pain characteristics by applying muscle energy technique to patients with moderate chronic obstructive pulmonary disease.Secondary aim, clinical status of muscle energy technique in moderate chronic obstructive pulmonary patients: assessment of dyspnea and functional levels: kinesiophobia, muscle strength and endurance of neck muscles, hand grip strength, functional capacity, daily living activity, exercise habits, exercise efficiency, self-confidence, posture and to examine its effects on quality of life. 52 volunteer participants, 35 and 65 years old, diagnosed with moderate COPD, will be divided into muscle energy technique group (MET) (n = 26) and control group (CG) (n = 26) using randomization (minimization) method. Individuals in the KET group will be applied muscle energy technique to certain muscles (Scalene(anterior-medius-posterior),Levator scapula,Sternocloidomastoideus, Upper trapezius, Pectoral muscles, Serratus anterior, Latissimus dorsi muscles) 3 days a week for 4 weeks and home exercise program applications will be requested. Individuals to be included in the study as a control group will be asked to apply home exercise programs 3 days a week for 4 weeks. All individuals included in the study will be re-evaluated parameters before, after and 6 weeks after the study. In our study, the sociodemeographic information of the individuals who signed the voluntary consent form will be recorded. Pain Intensity Visual Analogue Scale (VAS), pain screening and evaluation of clinical features Brief Pain Inventory, pressure pain threshold of trapezoidal muscle and cervical paravertebral muscles with algometer, assessment of dyspnea with Medical Research Council (MRC) Dyspnea Scale, Fear of re-injury due to movement and activity Using the Tampa Kinesophobia Scale (TKS), measurement of muscle strength of neck muscles Digital Hand-Held Dynamometer (HHD), evaluation of neck muscles endurance with body weight and sandbag measurement of hand grip strength Hand Grip dynamometer, with the six-minute walking test of functional capacity, daily life activity with the Glittre GYA test, effectiveness of exercise Exercise wounds and barriers scale, Postural analysis with Newyork Posture Scale, health-related quality of life the St. George's Respiratory Questionnaire (SGRQ), general health-related quality of life Short Form SF-36 questionnaire will be evaluated using.

Start: January 2021
MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology

Lung magnetic resonance imaging (MRI) with proton and inhaled inert gases has demonstrated a clinical ability to provide valuable structural and functional information in lung disease. Advances in lung MRI methods have led to our department handling clinical imaging referrals from local and national respiratory units. Hyperpolarised Xenon-129 gas MRI is now the gold-standard MRI modality used in clinical practice for asthma and COPD in Sheffield. In this new study we will use Xenon gas MR imaging and 19F gas MR imaging to obtain physiological, structural, and functional information about patients with known respiratory disease, namely asthma and COPD. Up to 20 patients with asthma and up to 20 patients with COPD will be recruited. Study visits will involve lung function tests and imaging using proton MRI, hyperpolarised xenon gas MRI, and 19F perfluoropropane MRI. After initial baseline assessments, patients will be followed up after 3 and 6 years to investigate the utility of MRI and lung function measurements in tracking disease progression over time. In addition, during the COVID-19 pandemic will also be studying the long term effects of this novel disease. We will use Xenon gas MR imaging and pulmonary vascular 1H MR imaging to obtain physiological, structural, and functional information about patients with COVID-19, including hospitalised patients and mild, non-hospitalised COVID-19 patients. Participants may be invited for baseline assessments during the symptomatic phase of the disease and/or be followed up after 6, 12, 24 and 52 weeks (in line with clinical follow up for hospitalised patients) to investigate long term effects of this novel disease. Our novel approach will provide mechanistic insight in to clinical observations such as : (i) why previously healthy patients can respond so poorly to oxygen/ventilation therapy, (ii) why patients respond to proning, and (iii) whether this is caused by alveolar-capillary interstitial changes and /or microvascular clotting in the pulmonary vasculature (leading to V/Q mismatch), and (iv) whether these acute changes lead to long term interstitial lung disease.

Start: September 2019
Fissure Closure With the AeriSeal System for CONVERTing Collateral Ventilation Status (CONVERT)

This is a prospective, open-label, multi-center, single-arm study to be conducted at up to 15 investigational sites. The Study plans to enroll 140 subjects with severe emphysema and collateral ventilation in the target lobe. This protocol is designed to evaluate the utility of the AeriSeal System to occlude collateral air channels in a target lung lobe with collateral ventilation (CV) and convert the target lung lobe to having little to no collateral ventilation. Subjects can then receive Zephyr Valves to achieve atelectasis in the targeted lobe, once AeriSeal has converted the CV+ lobe to a CV- one. Therefore, the study will have two Stages: • Stage 1 will address the closure of the lobar fissure gaps (or collateral air channels) to block collateral ventilation (CV) with the AeriSeal System; conversion of the CV+ target lobe to CV-. Conversion of collateral ventilation will be evaluated by Chartis after 45 days. In the case of unsuccessful conversion, a second treatment of AeriSeal may be attempted, provided that the total application volume from both the initial and the repeat treatments does not exceed 40 mL in up to three (3) segments. Clinical Assessments post-AeriSeal will be conducted at 28 and 45 days after first treatment and repeated after the second treatment, if applicable. For the purpose of protocol follow-up, the Day 45 post-AeriSeal final treatment will equal Day 0 for Stage 2. • Stage 2 will include successfully converted subjects; CV+ to CV- conversion in Stage 1. Converted CV- target lobes will follow standard of care and receive CE marked Zephyr Endobronchial valves per the Zephyr IFU to perform bronchoscopic lung volume reduction (BLVR). Clinical assessments will be conducted at 45 Days, 3 and 6-months post-Zephyr Valve procedure.

Start: December 2020
COmmunity Patients at Risk of Viral Infections Including SARS-CoV-2

Patients with a respiratory disease are at higher risk of poor outcomes due to worsening of symptoms caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and other respiratory infections. New therapies are needed for treating high risk patients at early stages of an infection. This study will assess the feasibility and safety of using an inhaled nitric oxide generating solution, RESP301, as a self-administered treatment following flare-up of symptoms. RESP301 is a liquid solution which produces nitric oxide in the lungs when inhaled using a nebuliser. The components of RESP301 are already used in clinical practice and inhaled nitric oxide is used as a treatment for newborns and patients with Chronic Obstructive Pulmonary Disease (COPD). In a laboratory setting, RESP301 has been shown to be effective against respiratory viruses, including SARS-CoV-2. This study aims to recruit approximately 150 adult patients with COPD or bronchiectasis in the United Kingdom (UK). A minimum of 70 participants will receive a test dose of RESP301 during a screening visit. Response to the test dose will be monitored. Participants who tolerate the test dose will continue in the study and should contact the study team if they experience exacerbation symptoms in the next 52 weeks. Following a call with the site team to discuss symptoms, participants will receive RESP301 delivered to their home to self-administer for 7 days. The study duration for each participant will be at most 57 weeks, including the study visit and monthly calls. Participants who start the course of study treatment, will receive daily calls during the treatment period and will also be followed up after they complete the treatment.

Start: April 2021