Ostroda

Researchers are evaluating the effect of AZD6793, an oral medication, in adults with moderate to very severe chronic obstructive pulmonary disease COPD. This Phase IIb, randomized, double-blind, placebo-controlled study involves approximately 970 participants across about 350 global sites. The trial aims to compare the efficacy and safety of two different doses of AZD6793 against placebo over a 24-week period. Participants will be randomly assigned to one of three groups receiving either dose 1 of AZD6793, dose 2 of AZD6793, or a matching placebo tablet. The study medication is taken orally and the trial lasts for 24 weeks. The study is designed as a parallel-group format with a 111 allocation ratio among the three arms. During the study, participants will be monitored through various assessments including lung function tests measuring forced expiratory volume FEV1, questionnaires evaluating breathlessness, cough, sputum, and quality of life, and tracking of COPD exacerbation events. Blood samples will be collected to measure plasma concentrations of AZD6793. Safety and efficacy outcomes will be evaluated up to 24 weeks, with the main outcome being the rate of moderate or severe COPD exacerbations.

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. This phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on participants already receiving inhaled maintenance therapy and who have experienced multiple COPD exacerbations in the previous year. The trial aims to understand tezepelumabs impact on reducing COPD flare-ups and improving lung function compared to placebo. Participants are randomly assigned to receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. The treatment period lasts between 52 and 76 weeks, followed by a 12-week safety monitoring period without treatment. Throughout the study, participants continue their inhaled COPD therapies, and their health is closely tracked to assess the study drugs effects. During the trial, participants will undergo various assessments including lung function tests, questionnaires measuring respiratory symptoms and quality of life, and blood tests to monitor drug levels and immune responses. Researchers will measure the annual rate of moderate or severe COPD exacerbations and other health outcomes over the study period. Safety will be monitored throughout treatment and during the follow-up period, with visits scheduled regularly to collect data and support participant care.

Researchers are evaluating the performance and safety of Debrisoft Duo compared to Debrisoft Pad for wound debridement. This study aims to confirm how well Debrisoft Duo works and to collect data on expected and unexpected adverse events when used as intended during routine care. The trial is designed as a multicenter, randomized, non-inferiority controlled clinical investigation involving patients with various wounds such as diabetic ulcers, arterial ulcers, pressure ulcers, burns, and surgical wounds. Participants will be randomly assigned to receive wound debridement with either the investigational Debrisoft Duo, a two-sided pad featuring a unique textured side to loosen adherent wound debris, or the comparator Debrisoft Pad, a one-sided pad without the textured side. Treatment occurs during a single study visit where clinical examinations and wound photographs will be taken to assess the debridement. During the visit, researchers will evaluate the reduction of fibrinous and necrotic tissue using standardized measures and investigator assessments. They will also monitor device-related adverse events, wound bed condition changes, pain levels, debridement time, product usage, and both patient and user satisfaction. The study focuses on safety and performance outcomes measured within one day after treatment, with participation limited to adult patients aged 18 and older.

Researchers are evaluating two types of PHMB-impregnated biocellulose wound dressings, SuprasorbXPHMB Pro and SuprasorbXPHMB, to compare their performance and safety in treating patients with infected venous leg ulcers. This multicenter, open-label, randomized parallel group controlled study focuses on patients with slight to moderate wound exudation, aiming to improve treatment outcomes for this condition. Patients with high wound exudation may first undergo a 7-day run-in period receiving superabsorbent dressings and monitored compression therapy, including systemic antimicrobial drugs if needed. After this, eligible patients will be randomly assigned to receive either SuprasorbXPHMB Pro or SuprasorbXPHMB dressings. All patients will receive their assigned dressing for about 21 days, or until complete wound healing occurs, alongside continued compression therapy and systemic antimicrobial treatment as required. Participants will be assessed at baseline, interim, and end-of-treatment visits for wound characteristics, exudation levels, infection status, pain, quality of life, and product usability. Dressing changes may occur as needed during the study. The main outcome measured is the rate and severity of skin maceration after three weeks of treatment. The study lasts about three weeks, after which further treatment is managed outside the trial.