Colchester

Researchers are evaluating the clinical and endoscopic effects of guselkumab in children aged 2 to 17 years with moderately to severely active Crohns Disease who show clinical response at Week 12. This Phase 3 study focuses on assessing the treatments impact at the end of a one-year maintenance period in pediatric participants with this condition. The trial is sponsored by Janssen Research & Development, LLC. Participants first receive guselkumab either intravenously or subcutaneously based on their body weight during a 12-week open-label induction phase. Those who respond at Week 12 are then randomly assigned to one of two subcutaneous guselkumab dosing regimens for a double-blind maintenance phase lasting up to Week 48. Non-responders at Week 12 enter an open-label maintenance phase with guselkumab subcutaneous dosing up to Week 48. Throughout the study, participants undergo clinical and endoscopic evaluations to measure remission and response rates, including endoscopic scores and clinical remission at Week 52. Additional assessments include growth measurements such as weight and height changes, and plasma concentrations of guselkumab. Safety is monitored with adverse event tracking up to Week 64, with the total duration of participation spanning just over one year.

This research aims to evaluate the long-term safety and explore the efficacy of astegolimab in adults aged 40 to 90 years with chronic obstructive pulmonary disease COPD. It focuses on participants who have completed a 52-week placebo-controlled treatment period in previous studies GB43311 or GB44332. The study is a phase 3, open-label extension to gather extended safety information on this drug in COPD patients. Participants from the parent studies who qualify will receive subcutaneous injections of astegolimab every two weeks throughout the study until it ends. This open-label extension allows all participants to receive the active drug without placebo comparison. The study continues treatment beyond the initial 52-week period to monitor long-term effects. During the study, participants will be monitored for adverse events up to 12 weeks after their last dose of astegolimab. Researchers will collect safety data to understand the incidence of any side effects. The study involves regular assessments and follow-ups to ensure participant well-being, with the total duration lasting until July 2034.

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 efficacy and safety of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease COPD who are receiving inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on adults aged 40 to 80 years who have experienced multiple COPD exacerbations in the year prior to enrollment. The trial aims to assess tezepelumabs impact compared to placebo on COPD exacerbations and lung function. Participants will receive monthly subcutaneous injections of one of two doses of tezepelumab or a matching placebo. Treatment duration ranges from a minimum of 52 weeks to a maximum of 76 weeks. Following the treatment period, participants will undergo a 12-week off-treatment safety follow-up to monitor any lasting effects. Throughout the study, participants will be regularly assessed for COPD exacerbations, lung function changes measured by forced expiratory volume FEV1, and quality of life using questionnaires such as the St. Georges Respiratory Questionnaire and COPD Assessment Test. Blood samples will be collected to measure drug levels and immune responses. Safety and efficacy will be closely monitored, with total participation lasting up to approximately 88 weeks including follow-up.

Researchers are conducting the American Lung Association ALA Lung Health Cohort, a multi-center, long-term observational study focusing on young adults aged 25 to 35 without severe lung disease. The study aims to understand lung health by examining various factors such as environmental exposures, physical activity, biomarkers, and respiratory cell activity to identify early markers and targets to prevent chronic lung diseases. Participants will undergo an initial baseline assessment to measure lung function, including pre-bronchodilator forced expiratory volume in one second FEV1 and forced vital capacity FVC. After this, regular remote contacts through text, email, mail, or phone will be used to follow up with participants for up to 4.5 years. Pending additional funding, the study may be extended beyond 5 years to explore long-term changes in lung health. During the study, participants will provide contact information and undergo lung function tests. Follow-up data will be collected remotely to monitor lung health over time. Researchers will track lung function measures and gather information on environmental and lifestyle factors. Safety and participant status will be monitored regularly, with the total study duration potentially extending beyond 5 years depending on funding.

Researchers are studying whether the drug omalizumab can help people aged 40 and older who have Chronic Obstructive Pulmonary Disease COPD and are allergic to common indoor allergens such as pet dander, cockroaches, or dust mites found in their homes. This phase 2 clinical trial aims to understand how omalizumab affects COPD symptoms and exacerbations in this specific group. Participants will receive either omalizumab injections or placebo injections normal saline given under the skin in the arm or leg at a clinic. The dose and frequency of injections are determined by the participants weight and blood IgE levels, with injections given monthly 12 doses or twice monthly 24 doses over a 12-month treatment period. Before treatment, there is a screening period lasting 1 to 3 months, and after the final injection, there will be a follow-up call one month later. During the study, participants will visit the clinic regularly to receive injections and be monitored for side effects. The main outcome measured is the rate of COPD flare-ups during the 12 months of treatment. Participants will also undergo assessments including lung function tests and allergy evaluations. The total time involved in the study is about 16 months from screening through follow-up.

Researchers are studying Idiopathic Pulmonary Fibrosis IPF and other chronic fibrosing interstitial lung diseases ILDs with a progressive phenotype through the IPF-PRO and ILD-PRO Registries. This prospective registry collects data on the natural history, healthcare experiences, quality of life, and treatments of participants diagnosed with IPF or other chronic fibrosing ILDs. Blood samples and chest imaging studies are also gathered and stored for future research. The registry originally enrolled over 1000 participants with IPF and expanded to include other fibrosing ILDs with progressive phenotypes, aiming to enroll up to 1000 additional patients in each phase.

Researchers are investigating how highly effective cystic fibrosis transmembrane conductance regulator CFTR modulators affect chronic rhinosinusitis CRS and problems with the sense of smell olfactory dysfunction in young children with cystic fibrosis. This observational study includes two groups of children aged 2 to 8 years those receiving highly effective modulator therapy HEMT and a control group not receiving HEMT. The goal is to understand if early use of HEMT improves sinus health and smell function over two years. Children in the HEMT group will have assessments before starting the modulator therapy and then again at one year and two years after starting treatment. Meanwhile, the control group will have similar assessments at baseline, one year, and two years without HEMT to observe the natural progression of their condition. The therapy studied includes ivacaftor or elexacaftortezacaftorivacaftor, prescribed by their doctors. Participants will undergo sinus MRI scans to measure sinus opacification and olfactory bulb volume, as well as objective smell tests and quality of life surveys at each visit. These evaluations will help track changes in sinus disease and olfactory function over time. The study is led by the University of California, Los Angeles and will continue through June 2029.