Ibague

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the effectiveness and safety of QMF149, a combination of indacaterol acetate and mometasone furoate, compared to budesonide in children aged 6 to less than 12 years with asthma. This Phase 3, double-blind, randomized, active-controlled, two-period, two-treatment cross-over study focuses on children with asthma who have lung function (FEV1) at or above 50% of the predicted normal value. The study aims to show whether QMF149 is superior to budesonide in improving asthma control. The study lasts up to 37 weeks and includes several phases: a screening period of up to 3 weeks, a 3-week run-in period where all participants receive fluticasone propionate, a first 12-week treatment period with either QMF149 or budesonide delivered once daily via Breezhaler, a 3-week washout period with fluticasone propionate, a second 12-week treatment period where participants switch treatments, and a 4-week safety follow-up where patients return to standard care as appropriate. The treatments are given once daily through an inhaler device. Participants attend scheduled visits every 3 weeks during screening and run-in, every 6 weeks during treatment periods, and a follow-up visit after safety monitoring. Assessments include lung function tests (FEV1), inhaler technique checks, symptom questionnaires, and monitoring of side effects. Researchers evaluate changes from baseline in trough FEV1 after each 12-week treatment to measure lung function. Safety information and survival status are collected at the end of the follow-up period.

Researchers are conducting a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). Participants must have experienced at least two moderate or one severe COPD exacerbations in the year before joining and be receiving inhaled maintenance therapy. The study focuses on adults who continue to experience symptoms despite current treatments and aims to assess the impact of tezepelumab on COPD exacerbations. Participants will be randomly assigned to 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 may extend up to 76 weeks. After the treatment period, there will be a 12-week safety follow-up phase to monitor participants after stopping the study drug. The study compares tezepelumab to placebo to determine its efficacy and safety over this extended period. During the study, participants will undergo regular assessments to monitor their COPD status and any exacerbations. The main outcome measured is the annual rate of moderate or severe COPD exacerbations from the start of treatment through up to 76 weeks. Safety and tolerability will also be closely monitored throughout the treatment and follow-up periods. This long-term involvement ensures comprehensive data on how tezepelumab affects COPD progression and exacerbation frequency.

Researchers are evaluating the effects of live Environmental Music Therapy (EMT) and pre-recorded music on anxiety, stress, pain, and well-being in adult patients and their caregivers waiting in emergency unit rooms at two hospitals in Colombia. The study aims to improve mental health and quality of care in these settings, addressing the limited previous research on music's impact in emergency waiting areas. This multi-center randomized clinical trial compares three groups: standard care with live EMT, standard care with pre-recorded music, and standard care alone. The live Environmental Music Therapy involves improvised music played for about 20 minutes, featuring slow to moderate tempos and simple melodies designed to create relaxing moments. The pre-recorded music intervention follows the same protocol. Participants are randomly assigned to one of the three groups using a secure envelope system, and the interventions take place in the emergency waiting rooms. The control group receives only the usual standard care without music exposure. Participants complete questionnaires measuring state anxiety, stress, pain, and well-being before and immediately after the 20-minute intervention. The primary measure is the six-item State-Trait Anxiety Inventory (STAI-6), while secondary measures include Visual Analogue Scales (VAS) for pain and stress and the Well-Being Numerical Rating Scales (WB-NRSs). The study monitors responses to assess how music interventions may influence emotional and physical states during emergency room waits.

Researchers are investigating the mental health of parents of preterm newborns who face stress, anxiety, and depression due to prolonged stays in neonatal intensive care units (NICUs). The study aims to evaluate whether music therapy songwriting combined with standard care helps reduce postpartum depression risk in these at-risk parents compared to standard care alone. Additionally, the study explores parents' personal experiences with music therapy during their infant's NICU stay. The trial uses a multicenter, mixed-method approach including a randomized clinical trial and a qualitative study. Parents receive either music therapy songwriting sessions plus standard care or standard care alone during their infant's hospitalization. The music therapy involves nine sessions where parents create and sing a personalized song with support from a music therapist, including options for original songs or parodies and incorporation of family messages. Final sessions focus on singing with their infant and optionally recording the song. Participants are assessed for depression and anxiety using established scales at baseline and weekly for three weeks during intervention. Secondary measures include resilience, coping, stress, and mental well-being. Researchers also conduct interviews to understand parents' experiences of music therapy songwriting. The study tracks changes in mental health scores and gathers qualitative insights to inform NICU support strategies.

Researchers are evaluating the bronchodilator effect, systemic exposure, safety, and tolerability of two doses of inhaled glycopyrronium compared to placebo in children aged 6 to less than 12 years with moderate to severe asthma. This Phase II study aims to determine the appropriate dose of inhaled glycopyrronium for developing a fixed dose combination treatment including indacaterol, mometasone, and glycopyrronium for this pediatric population. Participants must have asthma with a forced expiratory volume in one second (FEV1) between 60% and 90% of the predicted normal. The study is a double-blind, placebo-controlled, randomized, three-treatment, three-period, six-sequence crossover trial. It includes four phases: Screening, Run-in, Treatment, and Follow-up. During the Run-in and Treatment phases, participants continue their background asthma controller therapy containing salmeterol xinafoate and fluticasone propionate. The Treatment phase lasts 10 weeks, consisting of three two-week treatment periods with either 12.5 µg glycopyrronium bromide, 25 µg glycopyrronium bromide, or placebo inhaled via Breezhaler capsules. Two-week washout periods separate each treatment period. Participants who stop treatment early will have an Early Termination Visit, and all participants will have a safety follow-up call 30 days after their last treatment. Throughout the study, participants attend clinic visits for assessments including spirometry to measure trough FEV1 at the start and end of each treatment period. Researchers monitor efficacy, pharmacokinetics, pharmacodynamics, safety, and tolerability. Parents or legal guardians complete electronic diaries and attend all visits with the child. Total participation time from screening to follow-up is about 20 weeks, including safety monitoring after treatment ends.

Researchers are evaluating VX-147 for its effectiveness, safety, tolerability, and how the body processes it in adults and children aged 10 to 65 who have apolipoprotein L1 (APOL1)-mediated proteinuric kidney disease. This study is a Phase 2/3 trial designed to better understand treatment options for this specific kidney condition. Participants will receive either VX-147 or a placebo, both given as oral tablets. The study is double-blind and placebo-controlled, meaning neither participants nor researchers know who receives the active drug or placebo during the treatment period. The trial consists of two parts: Part A focuses on treatment effects over at least 48 weeks, while Part B involves continued safety and tolerability observation for approximately four years after the last participant enrolls. Throughout the study, participants will undergo regular assessments including measurements of urine protein to creatinine ratio and kidney function via estimated glomerular filtration rate (eGFR). Safety is monitored by tracking adverse events and serious adverse events. Data will be collected during the treatment period and followed long-term to evaluate both efficacy and safety outcomes, with some measures assessed at interim and final analyses over at least two years.

This research aims to assess the long-term safety of secukinumab in participants who have finished a previous Novartis secukinumab trial and are judged by their investigator to benefit from continued treatment but cannot access the marketed secukinumab form. The study focuses on individuals with autoimmune or inflammatory conditions and is conducted as a Phase 4 trial to monitor treatment safety over an extended period. Participants will receive secukinumab through subcutaneous injections using pre-filled syringes. The study is open-label and multi-center, designed for patients continuing secukinumab therapy after completing a parent study or in cases where the parent study ended prematurely for non-safety reasons. Treatment continuation depends on investigator judgment regarding benefit and risk balance. During the study, participants will be observed for up to two years to evaluate safety by tracking any adverse or serious adverse events. The study includes regular assessments to monitor participant health and treatment effects. Consent and communication with investigators are essential, and participants may sign informed consent or assent forms according to age and local laws. Overall participation duration and detailed safety monitoring are key components of the study.