Active clinical trials for "Respiratory Tract (Lung and Bronchial) Diseases"

Coverage Africa is a nested study in the large Anticov platform trial that aims to generate data on new early treatment strategies for mild/moderate COVID-19 patients in resource-limited-settings to reduce the number progressing to severe forms requiring hospitalization, thereby relieving the burden on health care systems and contributing to "flattening the curve" in contexts where none pharmaceutical intervention such as quarantine are difficult to implement in large urban settings. Treating early when the virus is still present might also limit transmission. Coverage Africa will be conducted in Guinea and Burkina Faso. The main objective is to conduct an open-label, multicenter, randomized, adaptive platform trial to test the safety and efficacy of several marketed products, including antiviral therapies versus control in mild/moderate of coronavirus disease 2019 (Covid-19) in resource-limited-settings. The study aims to recruit 600 patients in both countries, one site in Guinea and two sites in Burkina Faso. The current assessed treatments are now the association of Fluoxétine/Budésonide compared with a control arm: paracetamol. The adaptive design trial will allow for the removal of drugs, or the addition of new study arms when new data becomes available. Data on the primary efficacy parameters and safety will be integrated with the primary endpoint based on an oxygen saturation percentage (SpO2) ≤ 93% or death within 14 days after randomization to treatment, including death for any reason. Study will run until August 2022. However, with the proposed adaptive design, the study could also be interrupted for success earlier than planned with the identification of a treatment that significantly reduces hospitalization rate as evidence by results from the primary endpoint.

This phase II/III trial compares the addition of radiation therapy to the usual treatment (immunotherapy with or without chemotherapy [carboplatin, pemetrexed, paclitaxel, nab-paclitaxel]) versus (vs.) usual treatment alone in treating patients with non-small cell lung cancer that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic) whose tumor is also negative for a molecular marker called PD-L1. Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that uses high energy x-rays to kill tumor cells and shrink tumors. This method uses special equipment to position a patient and precisely deliver radiation to tumors with fewer doses over a shorter period and may cause less damage to normal tissue than conventional radiation therapy. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make DNA and may kill cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. The addition of radiation therapy to usual treatment may stop the cancer from growing and increase the life of patients with advanced non-small cell lung cancer who are PD-L1 negative.

MAGELLAN is a phase-I dose escalation trial that aims to identify the maximum tolerated dose (MTD) of MR-guided SBRT of ultracentral lung Tumors (primary objective). Thus, a maximum of 38 patients with ultracentral lung tumors (overlap of the planning target volume with the proximal bronchial tree and/or esophagus) will receive MR-guided SBRT including gated dose delivery and daily plan adaptation on a 0.35 MR-linac System. Dose levels are as follows: 0 (de-escalation): 10 x 5.0Gy 1 (start): 10 x 5.5Gy 2: 10 x 6.0Gy 3: 10 x 6.5Gy Dose escalation is performed according to a time-to-event continual reassessment method (TITE-CRM) with backup element. Patients are observed individually for 12 months to detect potential dose limiting toxicity (DLT = primary endpoint) and for a total of 24 months to detect potential tumor relapse.

This study will evaluate safety and efficacy of FF/UMEC/VI via ELLIPTA® inhaler. ELLIPTA is a registered trademark of GlaxoSmithKline group of companies.

This is an open-label, randomised, multicenter, Phase II study. This study is planned to enroll 80 eligible patients to receive durvalumab combined with up to 4 cycles of etoposide and platinum-based chemotherapy (EP). And approximately 64 patients who complete the 4 cycles of durvalumab + EP treatment and don't have progressive diseases (Non-PD patients) will be randomized in a 1:1 ratio to receive maintenance treatment durvalumab + anlotinib (Arm 1) or durvalumab (Arm 2) until confirmed progressive disease. Prophylactic cranial irradiation (PCI) is allowed at the investigators' discretion as per SoC guidance for ES-SCLC. Patients will attend a safety follow up visit 90 days after last dose of durvalumab. Tumor assessments will be performed at Screening with follow-up at Week 6 ±1 week and Week 12 ±1 week from the date of the first cycle treatment, and then every 8 weeks ±1 week until confirmed objective disease progression.

Primary objective: to investigate the efficacy of Mepolizumab 100 milligram (mg) every month compared to placebo in reducing validated Sinonasal Outcome Test -22 score and on reducing endoscopic Nasal Polyp Score. The participants have a triad of chronic rhinosinusitis with nasal polyps (CRSwNP), asthma and non-steroidal anti-inflammatory drug exacerbated respiratory disease (NERD). The investigators will evaluate whether mepolizumab reduces the need for increased drug dosage (topical corticosteroid or bronchodilator dosage) and improves lung and nasal function more effectively than placebo. This first visit ensures the inclusion and exclusion criteria of the subject. If necessary, NERD will be verified by an ASA challenge test at a second additional visit. Participants have also 6 visits, on four of which subcutaneous injection of the study product is administered. During visits, a clinical examination, airway function tests, and nasal, blood, urine, and stool samples are also taken to elucidate predictive biomarkers of severely symptomatic NERD patients.

Osimertinib is a third-generation EGFR (Epidermal growth factor receptor) TKI(Tyrosine kinase inhibitor) for the management of NSCLC(non-small cell lung cancer) harbouring EGFR(Epidermal growth factor receptor) T790M mutation after acquired resistance to previous first-generation EGFR (Epidermal growth factor receptor) TKI(Tyrosine kinase inhibitor) therapy. Moreover, osimertinib was approved or the treatment of patients with EGFR(Epidermal growth factor receptor) mutant NSCLC (non small cell lung cancer) in the first-line setting based on the clinical trial. The clinical activity and favorable toxicity profile of osimertinib has led to broadly research into this drug as a strategy to inhibit and prevent drug resistance in EGFR(Epidermal growth factor receptor) mutant NSCLC (non small cell lung cancer). Evidences of benefit from EGFR (Epidermal growth factor receptor) TKI(Tyrosine kinase inhibitor) in EGFR(Epidermal growth factor receptor) mutant NSCLC (non small cell lung cancer) patients have been increasing in early stages as well as in advance stages. Therefore, adjuvant or neo adjuvant EGFR (Epidermal growth factor receptor) TKI(Tyrosine kinase inhibitor) in operable NSCLC(non small cell lung cancer) patients could improve survival in EGFR(Epidermal growth factor receptor) mutant NSCLC (non small cell lung cancer) patients. Acquired resistance by widespread clinical use has become a hot clinical problem. A variety of target therapies are being developed to overcome tolerance to osimertinib to improve this outcome. This is an approach that should improve the molecular and clinical understanding of the drug resistance. Specifically, we want to investigate innate drug resistance and tumor microenvironment to osimertinib by performing single-cell RNA sequencing (scRNA-seq). and single cell research is obviously needed to develop cancer therapeutic strategies.

Allergic rhinitis (AR) is an immunoglobulin E-mediated inflammatory disease1 caused by hypersensitivity of the immune system to an allergen, affecting 100 million people in Europe 2and 400 million of the global population.The etiology of AR is multifactorial, resulting primarily from genetic predisposition, immunological response, and environmental pollutants.AR traditionally has been classified as seasonal (SAR) or perennial (PAR) depending on the causes and duration of symptoms. Some patients with AR prefer complementary and alternative medicine for their symptoms, with nearly 20% receiving acupuncture. According to the updated practice parameter of rhinitis in 2020, the use of acupuncture for the treatment of AR was not recommended due to a lack of well-controlled studies. The sphenopalatine ganglion (SPG), located under a thin (1-2 mm) layer of mucosa in the pterygopalatine fossa, consists of sensory fibers that innervate the nasopharynx, nasal cavity, and palate.Several studies have reported the benefit of SPG stimulation in chronic cluster headache and acute ischaemic stroke. Compared with traditional acupoints selected on basis of traditional meridian theory, acupuncture at SPG(inserting a needle through SPG acupoint (near ST7, Xiaguan) to reach and directly stimulate the SPG) may help patients ameliorate nasal symptoms immediately and improve quality of life by increasing sympathetic nerve excitability, but the evidence is inconclusive. We have designed this three-armed, randomized trial to investigate the efficacy and safety of acupuncture at SPG for the treatment of SAR. We hypothesize that acupuncture at SPG plus rescue medication is superior to sham acupuncture plus RM and RM alone in the treatment of SAR.

Patients with moderate to severe acute exacerbation of chronic obstructive pulmonary disease are often complicated with hypercapnia and respiratory failure, so they need to be admitted to ICU for monitoring and respiratory support treatment. Noninvasive ventilation has become the first-line respiratory support for the treatment of AECOPD with hypercapnia and respiratory failure. However, 26-54% of AECOPD patients with hypercapnia and respiratory failure eventually fail to receive noninvasive ventilation and need endotracheal intubation and invasive ventilation to maintain effective gas exchange. For these patients, the in-hospital survival rate is only 31-76%, and the prognosis is poor. In AECOPD patients with high risk of noninvasive ventilation failure and expected need of intubation, timely giving other ways of respiratory support to reduce blood CO2 may avoid patients receiving tracheal intubation and invasive ventilation, thus avoiding related complications and adverse prognosis. As a new type of respiratory support technology, ECCO2R is worthy of attention in monitoring and evaluation of support effect in AECOPD patients with respiratory failure. It is urgent that ECCO2R can effectively alleviate respiratory failure, avoid complications related to tracheal intubation, improve quality of life and reduce mortality.

The purpose of this research study is to learn about the effects of the medication ixazomib in participants with scleroderma/systemic sclerosis including its safety and tolerability, its effects on skin, lungs and other organs, and its effects on overall health and quality of life.