Pulmonary Fibrosis

Smoking negatively affects many organs and gradually worsens health, especially lung function. It causes mild airway obstruction and slows lung growth, impacting breathing and overall quality of life. This study evaluates balloon-blowing exercises combined with abdominal and lumbar core muscle activation positions to see if they can improve lung function and quality of life in smokers. Participants will be randomly assigned to one of two groups one will perform balloon-blowing exercises with abdominal and lumbar core muscle activation three times a week for four weeks, supervised by a physical therapist. The other group will perform diaphragmatic breathing exercises with the same frequency and duration. Both interventions last four weeks, with measurements taken before and after. Participants will undergo evaluations of lung function including forced vital capacity FVC, forced expiratory volume in one second FEV1, peak expiratory flow PEF, dyspnea levels, oxygen saturation, and quality of life assessments. These measures will be collected at the start and end of the four-week period to monitor changes and effects of the exercises on respiratory health.

This NIH-sponsored study aims to characterize three biomarkers derived from 129Xe gas exchange MRI and understand how they change in response to interventions. The study focuses on markers derived from the interaction of 129Xe with pulmonary capillary red blood cells RBCs, specifically RBC transfer MRI, cardiogenic oscillations in 129Xe-RBC signal amplitude, and the 129Xe-RBC chemical shift. The study population includes healthy volunteers, patients scheduled to undergo transfusion or phlebotomy, patients with dyspnea, interstitial lung disease ILD, idiopathic pulmonary fibrosis IPF, non-specific interstitial pneumonias NSIP, chronic hypersensitivity pneumonitis cHP, sarcoid, chronic thromboembolic pulmonary hypertension CTEPH, and acute pulmonary embolism.

Researchers are evaluating the safety, tolerability, pharmacokinetics PK, and immune response of a drug called SV001 compared to a placebo in healthy adult volunteers from China. This early phase 1, randomized, double-blind, and placebo-controlled study aims to understand how SV001 behaves in the body and whether it causes any adverse effects. The study focuses on adults aged 18 to 45 years who are in good health. Participants will receive a single dose of either SV001 or a placebo. The study uses a dose-escalation design, meaning doses may increase to assess safety. The trial is conducted at a single center and uses a quadruple-blind method where participants, care providers, investigators, and outcome assessors are unaware of which treatment is given. The intervention period includes administration of the study drug followed by monitoring. During the study, participants will undergo various assessments including monitoring for any treatment-emergent adverse events, measuring drug levels in the blood over time, and checking for immune responses to SV001. These evaluations will take place over approximately one year. Researchers will also monitor participants overall health, respiratory function, and conduct laboratory tests to ensure safety throughout the trial.

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously taken nerandomilast in another study. The aim is to assess how well patients tolerate long-term treatment with nerandomilast and to evaluate whether it improves lung function and delays worsening symptoms, hospital visits, or death. This open-label extension trial is sponsored by Boehringer Ingelheim and focuses on treatment over an extended period. Participants take nerandomilast tablets for up to 1 year and 10 months while continuing their usual pulmonary fibrosis treatments. The study involves a single treatment group receiving the drug, and no placebo or comparison groups. Regular visits with doctors help monitor health and collect data during this extended treatment phase. Throughout the study, participants undergo regular lung function tests and health assessments to track any adverse events and changes in lung capacity. The main outcome measured is the occurrence of any adverse events for up to about 99 weeks. Secondary outcomes include changes in forced vital capacity and time to worsening of disease symptoms or hospitalization. The study includes ongoing safety monitoring with a total participation time of up to nearly two years.

Researchers are evaluating the effect of providing access to two types of heated tobacco products HTP on smoking reduction and abstinence among healthy adult smokers aged 21 to 65 years in the United States. This multi-site, open-label study aims to assess how using HTP devices with different flavored stick variants influences smokers ability to stop or reduce combustible cigarette use over a 3-month period. The primary goal is to measure the rate of complete cigarette abstinence in the final seven days of the study. Participants are randomly assigned to one of two study groups one using a one-piece HTP device and the other using a two-piece HTP device. Each device group includes access to four stick variantstwo menthol and two tobacco flavorsunder the brand name virto. The study includes a 90-day actual use period where participants try all four stick variants during a 1-week product trial and then continue use as they choose. The interventions are designed to explore the impact of these devices and flavors on cigarette smoking habits. Throughout the study, participants complete questionnaires via a smartphone app and undergo assessments related to cigarette use and product preferences. Researchers track cigarette reduction, switching to HTP use, time to abstinence, and adverse events over the 3-month period. The primary outcome is self-reported abstinence from combustible cigarettes in the last 7 days of the study. Secondary measures include reduction in cigarette use by at least 50%, complete switching to HTP, and safety monitoring. The total study duration spans up to 3 months with ongoing data collection and follow-up.

This research aims to understand the risk factors, prevalence, and mortality associated with progressive pulmonary fibrosis PPF in patients who have interstitial lung disease ILD with pulmonary fibrosis visible on scans, excluding those with idiopathic pulmonary fibrosis IPF. It focuses on identifying connections between patient characteristics and progression of the disease over time. Participants will have initial assessments including collection of personal and medical histories, blood samples, detailed lung imaging high resolution computed tomography, lung function tests, and a 6-minute walk test. These evaluations will be repeated at 6 and 12 months, with additional blood samples and tests to monitor disease progression. Throughout the study, researchers will track lung function, exercise capacity, blood markers, and imaging results to measure disease progression and outcomes. The main goal is to link factors like age, gender, body mass index, and lung physiology scores to PPF progression over one year. The study extends up to 36 months to observe disease prevalence and long-term outcomes.

Coughing is a common and distressing symptom for people with interstitial lung disease ILD, affecting daily activities, work, and social life. This research explores a non-drug cough control therapy combined with pulmonary rehabilitation to see if it is practical and helps reduce chronic cough lasting more than eight weeks in ILD patients. The study aims to assess how well patients accept this therapy and whether it improves quality of life, cough symptoms, and fatigue compared to standard pulmonary rehabilitation alone. Participants will join a pulmonary rehabilitation program involving aerobic and strengthening exercises, disease-specific education, and self-management as usual care. Two weeks before finishing this program, they will receive four virtual sessions of 45 to 60 minutes each, focusing on cough control education and techniques. These sessions include assessing cough, learning suppression methods, breathing retraining, and reinforcing strategies to manage cough in daily life. During the study, researchers will track enrollment and attendance to measure feasibility, along with various clinical outcomes like cough severity questionnaires, fatigue scales, breathlessness ratings, and patient satisfaction interviews. The intervention is delivered online via Zoom, allowing remote participation. The total study duration averages one year, with ongoing assessments to understand the therapys impact and participants experiences.

Researchers are studying HW241045 in a Phase Ia clinical trial to evaluate its safety, tolerability, and how it is processed in the body after a single dose. This randomized, double-blind, placebo-controlled study involves healthy adult volunteers aged 18 to 55 years to better understand the effects of this drug compared to a placebo. Participants will receive a single oral dose of either HW241045 or a placebo. The study is designed with two groups one receiving the experimental drug and the other receiving placebo, both under blinded conditions to ensure unbiased results. The trial is conducted at a single center and uses a quadruple masking approach. During the study, participants will be closely monitored for any treatment-emergent adverse events within 48 hours after dosing. Assessments include safety checks, tolerability evaluations, and pharmacokinetic measurements. Participants health will be carefully observed during this period to understand the drugs effects and side effects. The total duration of participation is determined by these assessments and monitoring schedules.

Researchers are evaluating the combination of Adebrelimab with carboplatin or cisplatin plus etoposide chemotherapy and concurrent radiotherapy as a first treatment for patients with extensive-stage oligometastatic small cell lung cancer. This Phase II open-label study aims to assess the safety and effectiveness of this regimen in this patient group. The trial is led by Nanfang Hospital, Southern Medical University and focuses on patients with limited metastatic lesions and organs affected. Participants will first receive Adebrelimab intravenously along with carboplatin or cisplatin and etoposide for two cycles during the induction phase. Next, participants undergo concurrent chemoradiotherapy, including thoracic radiation and stereotactic body radiation therapy SBRT to metastases, combined with one to two cycles of chemotherapy. Following this, they will receive one to two additional cycles of Adebrelimab combined with chemotherapy, and then continue on Adebrelimab alone as maintenance therapy until disease progression, unacceptable side effects, or withdrawal from the study. During the study, participants will be closely monitored through clinical assessments, imaging, and laboratory tests to track progression-free survival and other measures such as overall survival and response rates, with follow-up lasting up to approximately 30 months. Safety will be monitored by recording adverse events throughout the treatment and maintenance phases. The total participation time includes induction, concurrent chemoradiotherapy, maintenance, and follow-up periods to fully evaluate treatment outcomes and tolerability.

Researchers are studying how anti-fibrotic medications affect body mass composition in patients with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF. These medications, such as nintedanib and pirfenidone, often cause side effects like nausea and loss of appetite, which may change body fat and muscle amounts. Traditional methods like weight and BMI dont detect these changes well, so this study uses bioimpedance analysis BIA and muscle ultrasound to better measure body composition. The study involves patients newly starting anti-fibrotic drugs and a control group of patients with similar lung disease but not beginning these medications. BIA measures body composition quickly by attaching electrodes for about 6 seconds, while muscle ultrasound assesses thigh muscle size. Additional measurements include mid-arm circumference, physical tests like sit-to-stand and walking speed, and questionnaires on quality of life, physical activity, and gastrointestinal symptoms. Participants will provide a 3-day diet diary as well. Assessments occur before starting the medications and again after four months to track changes. Researchers will evaluate the feasibility of these measurements, the acceptability of BIA and ultrasound, and collect data on muscle strength, body weight, height, and questionnaires at both time points. The study aims to understand the impact of anti-fibrotic drugs on body composition and related physical functions in these patients over this period.