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Lung Diseases, Obstructive clinical trials

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NCT ID: NCT05311306 Active, not recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

REported Outcomes in COPD With Trixeo in Real worlD in Germany

RECORD
Start date: March 15, 2022
Phase:
Study type: Observational

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.

NCT ID: NCT05309356 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Using Clinical Prediction Models to Improve Treatment for Patients With Chronic Obstructive Pulmonary Disease (COPD)

Start date: March 21, 2023
Phase: N/A
Study type: Interventional

Chronic Obstructive Pulmonary Disease (COPD) is a chronic disease of the lungs that affects more than 2.5 million Canadians. Patients with COPD experience episodes of lung attacks (or exacerbations). During these attacks, patients experience an intense increase in symptoms, such as breathlessness and cough. It is challenging to decide which patients should be put on treatments that would reduce the risk of such lung attacks. The digitization of health records in many clinics and hospitals means complex risk prediction algorithms can be used to predict the risk of lung attacks to enable personalized care. In this study, our team will implement a risk prediction tool (called ACCEPT) into the electronic health records in two teaching hospitals in Vancouver, British Columbia (BC), Canada. A clinical study will be conducted to evaluate if the use of this tool results in patients with COPD receiving better care with better outcomes, and if they are more satisfied with the care they are receiving.

NCT ID: NCT05306743 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

PRagmatic EVAluation of a Quality Improvement Program for People Living With Modifiable High-risk COPD.

PREVAIL
Start date: September 23, 2022
Phase: N/A
Study type: Interventional

A 3-year cluster randomized controlled trial of the impact of a quality improvement and clinical decision support package versus usual care for patients with modifiable high-risk chronic obstructive pulmonary disease with or without a current diagnosis.

NCT ID: NCT05299385 Recruiting - Lung Cancer Clinical Trials

The Study for Evaluating the Clinical Effectiveness and Safety of Respiratory Rehabilitation Software 'Redpill Breath'(COPD, Asthma, Lung Cancer, Etc.)

Start date: January 13, 2022
Phase: Phase 3
Study type: Interventional

The purpose of the study is to prove the clinical superiority of respiratory rehabilitation software "Redpill Breath" and evaluate the clinical improvement effect by 6-minute walk test of the software, compared to the manual rehabilitation management for those who need respiratory rehabilitation(COPD, Asthma, Lung Cancer, etc.)

NCT ID: NCT05297279 Recruiting - Clinical trials for COPD, Chronic Obstructive Pulmonary Disease

OMEGA - Dietary Intervention - COPD Trial

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

A randomized controlled trial of a food delivery dietary intervention targeting increased omega-3 intake to determine whether dietary modifications can improve Chronic Obstructive Pulmonary Disease (COPD) outcomes and attenuate the adverse effects of particulate matter on respiratory health. Investigators believe that study results will comprehensively address the impact of an evidence-based nutrition intervention on COPD health and provide a framework for dietary intervention within other chronic diseases disproportionately impacting susceptible, low-income populations.

NCT ID: NCT05295355 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Effect of Tiotropium Bromide Combined With Odaterol on Small Airway Remodeling in Patients With Mild to Moderate Chronic Obstructive Pulmonary Disease

Start date: January 25, 2021
Phase: N/A
Study type: Interventional

72 patients with mild to moderate chronic obstructive pulmonary disease were planned to be enrolled in this study and then treated with olodaterol combined with thiotropium bromide, and thiotropium bromide, respectively, for 52 weeks. To assess the effect of the test drug on small airway remodeling in patients.

NCT ID: NCT05292950 Recruiting - Asthma Clinical Trials

Study of ARO-MUC5AC in Healthy Subjects and Patients With Muco-Obstructive Lung Disease

Start date: June 27, 2022
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of ARO-MUC5AC in normal healthy volunteers (NHVs), patients with moderate-to-severe asthma and patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). In part 1 NHVs will receive a single dose of ARO-MUC5AC or placebo. In part 2 of the study, NHVs, adult patients with asthma, and adult patients with COPD will receive 3 doses of ARO-MUC5AC or placebo.

NCT ID: NCT05292196 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease (COPD)

A Phase II Clinical Trial of TQC3721 Suspension for Inhalation

Start date: May 20, 2022
Phase: Phase 2
Study type: Interventional

TQC3721 suspension for inhalation is a PDE3/4 inhibitor developed by Chia Tai Tianqing Pharmaceutical Group Co., LTD., which can simultaneously achieve bronchial smooth muscle relaxation and anti-inflammatory effects. This is a randomized, double-blind, placebo-parallel, phase II trial of the efficacy and safety of inhaled TQC3721 suspension/placebo at different doses in patients with moderate to severe chronic obstructive pulmonary disease. Objective To evaluate the efficacy, safety and tolerability of TQC3721 inhalation suspension in the treatment of moderate to severe Chronic Obstructive Pulmonary Disease (COPD).

NCT ID: NCT05287555 Recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Efficacy of Telemetry-assisted Care in Home Home Vented COPD

TeleInterVENT
Start date: April 25, 2022
Phase: N/A
Study type: Interventional

This study in patients suffering of Chronic Obstructive Pulmonary disease (COPD) aims to investigate whether telemonitoring of their non invasive ventilation (NIV) device together with targeted, tailored intervention in case of increasing symptoms or ventilation abnormalities improves the therapy adherence and effectiveness and can reduce the need for hospitalizations.

NCT ID: NCT05286918 Not yet recruiting - Clinical trials for Pulmonary Disease, Chronic Obstructive

Antibiotic Stewardship in AECOPD Through CRP-Guided Management

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Objectives: To determine whether CRP-guided antibiotic treatment for managing AECOPD in adult patients attending Emergency Departments leads to reduced antibiotic duration, without non-inferior COPD health status with usual care. Hypothesis to be tested: (i) The antibiotic duration in AECOPD patients will be significantly lower for CRP-guided antibiotic discontinuation than usual care; and (ii) COPD health status as measured by the Clinical COPD Questionnaire has no statistically significant difference between two groups. Design and subjects: Multi-center, single-blind, open-label, randomized, combined superiority (antibiotic duration) and non-inferiority (COPD health status) trial in 1,184 adult AECOPD patients presented to A&E. Instruments: Clinical COPD Questionnaire and EuroQol-5D Interventions: Both intervention and control groups follow usual care with GOLD strategy. The intervention group will be recommended to test for serum CRP daily. Antibiotic prescription is considered when CRP >5mg/dL. Once CRP has declined to <5mg/dL and the patient was afebrile for past 48 hours, antibiotic discontinuation will be considered. Communication with Receiving Ward Staffs: Participants in the study may transfer to another departments after treatment/ care in A&E. The following communication would be conducted: - A handover note that informs the receiving ward staffs about patients' enrolment to the trial, group assignment, and previous treatments given in A&E. The note would also suggest the investigations for the receiving ward staffs. - Telephone handover about intervention group and investigations of the study, and treatments given in A&E to ward. Main outcome measures: The antibiotic duration (total number of antibiotic days) within 28 days and recovery in terms of COPD health status (Clinical COPD Questionnaire total scores) within 14 days from randomisation. Data analysis: Intention-to-treat and cost-effectiveness analyses will be performed. The outcome assessors and data analysts will be blinded to group allocation. Expected results: The intervention group will exhibit reduction in antibiotic duration at 4-weeks, without negatively impacting on COPD health status, compared with the control group.