Spearwood

Researchers are evaluating the long-term safety and effects of nerandomilast in people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously completed treatment with nerandomilast in earlier studies. The study aims to understand how well participants tolerate nerandomilast over time, and whether it helps improve lung function, delays symptom worsening, reduces hospital visits, or impacts survival. This is a Phase 3 open-label extension trial. Participants take nerandomilast tablets daily for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study follows an open-label design where all participants receive nerandomilast. There are no placebo or comparator groups in this extension phase. Throughout the study, participants regularly visit their doctors for health assessments and lung function tests. Doctors monitor any health problems or side effects experienced during treatment. The main outcome measured is whether participants experience any adverse events up to the final follow-up visit, which occurs at week 99. This close monitoring helps evaluate the long-term safety and potential benefits of nerandomilast in this patient group.

Researchers are evaluating the efficacy, safety, and tolerability of two dosing regimens of itepekimab compared to placebo as an add-on treatment to intranasal corticosteroids in adult men and women with chronic rhinosinusitis with nasal polyps (CRSwNP). This multinational, randomized, double-blind, placebo-controlled Phase 3 study includes participants aged 18 years and older who have inadequately controlled CRSwNP. The study aims to better understand how these treatments impact nasal polyp symptoms and disease control over a one-year period. Participants will be randomly assigned to receive one of two dosing regimens of itepekimab or a placebo, all administered by subcutaneous injection. All participants will continue using mometasone furoate nasal spray as standard intranasal corticosteroid therapy. Treatment will last up to 52 weeks, followed by a 20-week safety follow-up period. The study includes a total of 9 site visits and 20 phone or home visits during the participant's involvement. Participants will be involved in regular assessments including endoscopic nasal polyp scoring and nasal congestion symptom evaluations at baseline and throughout the 24 weeks, among other time points. Researchers will monitor changes in nasal polyp scores and nasal congestion scores to measure the treatment effects. Safety and tolerability will be closely followed during the treatment and safety follow-up periods, with total participation lasting up to 76 weeks for most participants, or 56 weeks for those transitioning to an extension study.

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

This research aims to assess the effectiveness and safety of eloralintide in adults with moderate to severe obstructive sleep apnea who are also obese or overweight. The study is organized under a master protocol called YDAO, which supports two separate studies: YSA1 for participants who are unable or unwilling to use Positive Airway Pressure (PAP) therapy, and YSA2 for those who have been using PAP therapy for at least three months and intend to continue it during the study. This is a Phase 3 randomized, double-blind, placebo-controlled trial focused on this specific population. Participants will receive either eloralintide or a placebo, both given by subcutaneous injection once weekly. They will be assigned to one of two groups based on their current PAP therapy use: those not using PAP (YSA1) and those continuing PAP (YSA2). The study treatment and observation will last about 76 weeks, allowing detailed evaluation over time. During the study, participants will undergo assessments including polysomnography to measure the apnea-hypopnea index (AHI) and body weight changes from baseline to week 64. Researchers will monitor weight, sleep apnea severity, and safety throughout the trial. The long participation period includes screening, treatment, and follow-up to capture comprehensive data on eloralintide’s effects and tolerability.

This research aims to evaluate the safety and effectiveness of belimumab in adults with interstitial lung disease (ILD) related to connective tissue diseases (CTDs) such as rheumatoid arthritis, lupus, and others. ILD causes lung inflammation and stiffness, reducing lung volume and leading to symptoms like shortness of breath, cough, and fatigue, significantly affecting quality of life and being a leading cause of death in these patients. The study focuses on whether adding belimumab to standard therapy can stabilize or improve lung function and relieve ILD symptoms while maintaining an acceptable safety profile. Participants will be randomly assigned to receive either belimumab or a placebo, both administered as a subcutaneous injection alongside their standard treatment. The study is a phase 3, double-blind, placebo-controlled trial designed to compare these two groups over time. Belimumab treatment is given under careful monitoring to assess its impact on lung disease progression. Throughout the study, participants will undergo assessments including lung function tests, specifically measuring forced vital capacity (FVC) at the start and after 52 weeks. Researchers will monitor changes in lung capacity to determine treatment effects. Participants will be evaluated for safety and symptom changes, with ongoing review of their ability to manage their condition. The total duration includes regular follow-ups and assessments to understand the long-term impact of the treatment.

This research aims to evaluate the long-term safety and explore the effectiveness of astegolimab in people with chronic obstructive pulmonary disease (COPD) who have already completed a 52-week treatment in previous studies GB43311 or GB44332. The study focuses on participants aged 40 to 90 years and is a Phase III open-label extension trial designed to continue monitoring patients after their initial treatment period. Participants will receive astegolimab as a subcutaneous injection every two weeks during this extension study. This treatment continues from the prior placebo-controlled phase, allowing researchers to observe any ongoing effects and safety concerns over a longer period. The study does not include a placebo group during this extension phase, and all participants receive the active treatment. Throughout the study, researchers will closely monitor participants for any adverse events up to 12 weeks after the last dose of astegolimab. Participants will be assessed regularly to ensure their safety and to gather data on the treatment's long-term impact. The total duration of participant involvement depends on when they completed the parent studies but involves continued monitoring during and after the treatment 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.

This study is open to adults and adolescents aged 12 to under 18 with bronchiectasis. People can participate in this study if they produce sputum and have had flare-ups (also called exacerbations). The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis. Participants are put into 2 groups randomly, which means by chance. One group takes BI 1291583 tablets and the other group takes placebo tablets. A placebo tablet looks like the BI 1291583 tablet but does not contain any medicine. Participants take 1 tablet once a day for up to 1 year and 6 months. Participants are in the study for up to 1 year and 8 months. During this time, participants visit the study site up to 10 times and get about 13 phone calls from the site staff. Participants regularly complete a diary on a smartphone about their bronchiectasis symptoms and study doctors regularly check for any changes. The study doctors document when participants experience flare-ups. The number of flare-ups is compared between the participants who receive BI 1291583 and those who receive the placebo. The study doctors also regularly check participants' health and take note of any unwanted effects.