Ostroda

Researchers are evaluating the effects and safety of AZD6793 tablets in adults aged 40 years and older who have moderate to very severe chronic obstructive pulmonary disease (COPD). This is a Phase IIb, multicenter, randomized, double-blind, placebo-controlled study involving approximately 1160 participants at around 400 sites worldwide. The study aims to compare three different doses of AZD6793 against placebo tablets over 24 weeks to assess how well the treatment works and its safety profile in this population. Participants will be randomly assigned to one of four groups receiving either one of three doses of AZD6793 or a placebo in equal proportions. The treatment involves oral administration of AZD6793 tablets or placebo tablets daily for 24 weeks. The study is designed with parallel groups and includes careful dose-ranging to evaluate different levels of the investigational drug. During the study, participants will be monitored for the annualized rate of moderate or severe COPD exacerbations from baseline up to 24 weeks. Assessments include lung function tests such as pre- and post-bronchodilator FEV1/FVC ratios, symptom questionnaires like the COPD Assessment Test (CAT), and documentation of COPD exacerbation history. Safety will be continually evaluated through clinical assessments and laboratory tests throughout the treatment period.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). These participants must have a history of COPD for at least one year and have experienced multiple COPD exacerbations despite using inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on those who have had at least two moderate or one severe exacerbation in the prior year while on inhaled triple or dual therapy. Participants will receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and up to 76 weeks. After the treatment period, there will be a 12-week off-treatment safety follow-up to monitor any lasting effects or safety concerns. During the study, researchers will assess the participants' lung function and monitor the annual rate of moderate or severe COPD exacerbations. Participants will undergo screening to confirm eligibility based on lung function tests, eosinophil counts, and symptom scores. Safety will be closely monitored throughout the treatment and follow-up periods to evaluate adverse effects and overall participant health.

Researchers are conducting a multicenter, randomized, non-inferiority trial to compare the performance and safety of Debrisoft Duo with Debrisoft Pad in the debridement of various wounds. The study aims to confirm how well Debrisoft Duo works, collect safety data on expected adverse events, and identify any unexpected adverse events during routine use. The wounds studied include diabetic ulcers, arterial ulcers, venous ulcers, pressure ulcers, postoperative wounds healing by secondary intention, burns and scalds, epidermolysis bullosa, traumatic wounds, and surgical wounds. Participants are randomly assigned to have their wounds debrided with either the two-sided Debrisoft Duo pad or the one-sided Debrisoft Pad during a single study visit. During this visit, patients undergo a clinical examination and wound photographs are taken to assess the wound. The wound area must be larger than 4 cm2 and covered with at least 30% debris, necrosis, slough, or fibrotic tissue. The entire wound should be visible in one photo taken from a distance of 25-30 cm. Throughout the study visit, researchers monitor wound changes, focusing on the reduction of fibrinous and necrotic tissue using the W.H.A.T. measure within one day. Patients are assessed clinically, and photos document wound status to evaluate treatment effects. Safety data is collected to detect any adverse events related to the devices. The study does not include a long-term follow-up period beyond this single visit assessment.

Researchers are evaluating the performance and safety of two types of PHMB-impregnated biocellulose wound dressings in treating patients with infected venous leg ulcers. This multicenter, open-label, randomized controlled study focuses on patients with slight to moderate wound exudation, comparing Suprasorb®X+PHMB Pro with Suprasorb®X+PHMB dressings. The study aims to assess the rate and severity of wound maceration after treatment. Eligible patients with slight or moderate wound exudation are randomly assigned to receive either Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB dressing applied with compression therapy. Patients with high wound exudation enter a 7-day run-in period receiving superabsorbent dressings and monitored compression therapy, along with systemic antimicrobial treatment if needed. After this period, if exudation decreases to a moderate level and eligibility criteria are met, they are randomized to one of the two treatment groups. Patients receive assigned dressings for 21 (±2) days or until complete healing, continuing compression and antimicrobial therapy as required. Participants are assessed at baseline, interim, and end-of-treatment visits for wound parameters. Dressing changes may occur as needed between visits. After 3 weeks of treatment, the study concludes for each patient, and any further care is outside the study scope. The main outcome measured is the rate and severity of wound maceration after treatment with Suprasorb®X+PHMB Pro or Suprasorb®X+PHMB.