Boerne

Researchers are studying the effects of galvokimig compared to a placebo in adults aged 40 to 80 who have moderate-to-severe chronic obstructive pulmonary disease COPD with chronic bronchitis. The study aims to measure the time until the first acute exacerbation of COPD AECOPD in this group. This phase 2 trial seeks to understand how galvokimig may impact disease flare-ups and patient outcomes. Participants will be randomly assigned to one of three groups two different dose levels of galvokimig or a matching placebo, all given as injections. The treatment period lasts between 24 and 52 weeks. The study uses a quadruple-blind design, meaning neither participants nor the researchers know which treatment is given to ensure unbiased results. During the trial, participants will be monitored for lung function through tests like forced expiratory volume in 1 second FEV1, as well as assessed for respiratory symptoms using questionnaires such as the St. Georges Respiratory Questionnaire-COPD-specific version SGRQ-C. Researchers will record the rate and severity of COPD exacerbations and track any adverse events. The primary outcome focuses on the timing of the first moderate or severe AECOPD up to 60 weeks. Safety and quality of life are also evaluated throughout the study.

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 studying the effects and safety of the medicine PF-07275315 for adults aged 35 to 80 with moderate to severe chronic obstructive pulmonary disease COPD. COPD makes breathing difficult and reduces quality of life. This clinical trial aims to evaluate PF-07275315 compared to placebo to assess its potential as a treatment for COPD. Participants will receive either multiple injections of PF-07275315 or placebo shots in a clinic over 24 weeks for the Phase 2 part and 52 weeks for the Phase 3 part. The study uses a randomized and parallel design to compare outcomes between the groups. Phase 2 participants will have 11 clinic visits over about 40 weeks, while Phase 3 participants will have 18 visits over about 68 weeks. During the trial, participants will undergo lung function tests including forced expiratory volume FEV1 measurements, and assessments of COPD exacerbations. Researchers will monitor safety, adverse events, and changes in respiratory symptoms and quality of life. The study includes regular clinic visits for treatment and evaluations, with the total duration depending on the phase of participation.

Researchers are evaluating the safety and effects of a medicine called PF-07275315 for treating adults with moderate-to-severe asthma that is not well controlled. The study focuses on adults aged 18 to 70 who have had asthma for at least 12 months and have been on regular maintenance treatments. Asthma is a condition that makes breathing difficult and can reduce quality of life and daily functioning. Participants will receive either PF-07275315 or a placebo through multiple injections under the skin during clinic visits over a 12-week period. The study is randomized and blinded, meaning neither participants nor researchers know who receives the medicine or placebo. The trial includes several experimental groups receiving different doses of PF-07275315 and a group receiving placebo to compare safety and effects. The study includes a 12-week treatment phase. During about 7.5 months of involvement, participants will attend nine clinic visits. Researchers will monitor lung function using tests like forced expiratory volume in 1 second FEV1, record any side effects or adverse events, and assess asthma control and quality of life through questionnaires. Safety will be followed for 24 weeks, including lab tests, vital signs, and heart monitoring. This helps understand how PF-07275315 affects lung function and overall health in asthma patients.

Researchers are evaluating the safety, tolerability, and activity of an inhaled drug called GDC-6988 in adults with muco-obstructive diseases, including non-cystic fibrosis bronchiectasis and chronic obstructive pulmonary disease COPD. This Phase 1 clinical trial aims to understand how this inhaled treatment affects lung function and respiratory symptoms in these patients. Participants receive GDC-6988 using a dry powder inhalation device. Different groups receive varying doses and schedules one group receives a low dose followed by a high dose on the first two days, another group receives both doses twice daily for 14 days, and other groups receive low dose twice daily for 14 days. The study is open-label and conducted at multiple centers. During the study, participants undergo lung function tests, including spirometry, and provide sputum and blood samples for biomarker analysis. Researchers monitor adverse events and lung function changes for up to 6 weeks after treatment starts. They also assess changes in mucus properties and lung clearance using specialized imaging. The trial involves repeated assessments over 14 days of treatment and follow-up evaluations extending to 6 weeks.

Researchers are evaluating the efficacy and safety of tozorakimab delivered under the skin in adults with uncontrolled asthma who are already using medium-to-high doses of inhaled corticosteroids. This phase IIb, double-blind, placebo-controlled study aims to find the optimal dosing range of tozorakimab in this population. The study is sponsored by AstraZeneca and uses a randomized, parallel design to compare different doses and placebo. Participants will receive subcutaneous injections of either tozorakimab at one of two dose levels or a placebo. The study arms include dosing with tozorakimab Dose 1, tozorakimab Dose 2, or placebo, administered under the skin. The treatment period lasts from 26 to 52 weeks, during which participants will be monitored for their asthma symptoms and lung function. Throughout the study, participants will undergo assessments including lung function tests such as forced expiratory volume in 1 second FEV1, asthma control questionnaires ACQ-6, quality of life questionnaires AQLQ12, and measurements of asthma exacerbations. Blood samples will be collected to measure drug levels and immune response. Safety and adherence will be closely monitored, and the primary outcome is the annualized rate of severe asthma exacerbations over the treatment period.

Researchers are evaluating the effects of dupilumab treatment on children aged 2 to under 6 years with uncontrolled asthma andor recurrent severe asthmatic wheeze. This Phase 3 study aims to assess both the efficacy and long-term safety of dupilumab compared to a placebo. The study is conducted in two parts to thoroughly evaluate treatment outcomes and safety over an extended period. In Part A, children will be randomly assigned to receive either dupilumab or a matching placebo through subcutaneous injections over a 52-week treatment period following a 4-week screening phase. After this, there is a 12-week follow-up to monitor any ongoing effects. Participants who qualify may choose to enter Part B, an optional open-label extension where all receive dupilumab for an additional 52 weeks, followed by another 12-week safety follow-up. Throughout the study, participants will be regularly assessed for asthma exacerbations, medication use, symptom control, quality of life, and medication safety. Caregivers will complete diaries and questionnaires about asthma symptoms and control. Blood tests will monitor eosinophil levels, immune responses, and drug concentrations. The total time in the study can be up to 120 weeks, allowing researchers to observe long-term treatment effects and safety.

Researchers are evaluating the efficacy, safety, and tolerability of a subcutaneous drug called lunsekimig compared to placebo in adults aged 40 to 80 years who have inadequately controlled Chronic Obstructive Pulmonary Disease COPD with an eosinophilic phenotype. This Phase 2b3 study aims to better understand how lunsekimig might affect COPD symptoms and exacerbations in this specific group. Participants will be randomly assigned to one of three groups lunsekimig dose regimen A, lunsekimig dose regimen B, or a matching placebo. All treatments are given by subcutaneous injection during a 48-week intervention period. The study includes a screening period up to 4 weeks before treatment and an approximately 8-week follow-up after the intervention, for a total duration of up to 60 weeks. During the study, participants will have regular assessments including lung function tests and symptom questionnaires. Researchers will monitor the annual rate of moderate-to-severe COPD exacerbations as the primary outcome. Secondary measures include changes in lung function and quality of life scores, along with safety evaluations such as monitoring adverse events and laboratory tests. Blood samples will be collected to measure drug levels and antibody responses. Participants are observed throughout the treatment and follow-up periods to assess the effects and tolerability of lunsekimig.