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355 active trials for Asthma

Characterizing Asthma Sputum Elasticity in the UCSF Severe Asthma Research Program

This study is designed to characterize subjects in terms of their sputum phenotype. The purpose of this study is to learn more about the impact of having abnormally elastic sputum on asthma severity by comparing subjects with severe as well as mild/moderate asthma to healthy controls. The characterization will include medical history, pulmonary function testing, imaging of the lungs and biospecimen collection.

Start: September 2015

Characterization of Adult Subjects for Asthmatic Research Studies

This study is designed to characterize subjects in terms of the nature and severity of their asthma and in terms of conditions that may alter the clinical expression of asthma. Some features will be obtained in all subjects. These include a medical history and baseline lung function tests. This characterization forms the basis for our database that facilitates research protocols.

Start: May 2010

Study of the Effect of Innate on the Inflammatory Response to Endotoxin

Background: - Innate immunity is the process by which white blood cells and other parts of the immune system sense and respond to potential infections by causing an inflammation. Researchers are interested in studying how the body responds to certain environmental factors, and whether the body s response can contribute to chronic illnesses or diseases such as asthma and certain types of cancers. Objectives: - To examine how specific genes and proteins in blood cells respond to environmental exposures. Eligibility: - Healthy volunteers between 18 and 45 years of age. Design: The study will involve one visit of 45 to 60 minutes. Participants will be screened with a brief physical examination and finger stick to determine if they are eligible to donate blood for the study, and will complete a questionnaire about any medications or other drugs (e.g., cigarettes) they may be taking. Participants will provide a blood sample for research purposes.

Start: July 2012

Innovative Steroid Treatment to Reduce Asthma Development in Children After First-time Rhinovirus Induced Wheezing

The overall objective of the study is to determine the efficacy of corticosteroids in preventing recurrent wheezing and asthma in high-risk, first-time severe wheezing children with rhinovirus infection. The secondary objectives are to determine duration and severity of each acute episode with acute expiratory breathing difficulty, the number of episodes with acute expiratory breathing difficulty, degree of pulmonary hyperreactivity and quality of life within 24 months after study entry.

Start: May 2019

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Background: - Asthma is a serious clinical and public health problem. Researchers want to collect data to better understand how bacteria and other things in the environment can affect people's asthma. Eligibility: - Nonsmoking adults age 18 - 60 who have moderate to severe asthma and are not pregnant or breastfeeding. Design: Partaicipants will complete a medical history form before the first visit. Study visits will include collecting medical history, and conducting physical exam, lung and smoking tests. Participants will give blood, urine, stool, dust, saliva, and sputum samples. Participants will take tests that measure their breathing abilities. They will give saliva samples for DNA study. They will get kits to collect stool and dust samples at home. They will fill out surveys. Participants will have visits every 6 months for 5 years. They can schedule sick visits, if needed, at no cost to the participant. For all visits, they will have asthma check-ups and get treatment, at no cost to the participant. Some participants may take part in a sub-study that includes one 4-hour visit. They will have medical history, physical exam, and lung tests. They will have urine tests to check for pregnancy and tobacco exposure. Then they will have bronchoscopy. For this, an intravenous line will be placed in an arm vein. The nose and throat will be numbed. A flexible fiber-optic tube will be inserted into their airways through the nose. Their airways will be examined and areas of their lung will be washed. A small sample of cells will be taken.

Start: September 2015

Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma

The purpose of this study is to determine the efficacy and safety of multiple CSJ117 doses (0.5; 1; 2; 4 and 8 mg) inhaled once daily compared with placebo, when added to standard-of-care (SoC) asthma therapy in adult patients with uncontrolled asthma with respect to change from baseline in FEV1 at the end of 12 weeks of treatment.

Start: September 2020

Digital Adherence Monitoring of Inhalative Therapy in Real- Life Conditions

This study is designed as a multicenter, observational, non-interventional, open label, 26-week study in order to observe how asthma control changes under treatment with Mometasone Fuorat/Indacaterol/ Glycopyrronium (MF/IND/GLY) Breezhaler® sensor system or under treatment with fixed-dose combination (FDC) triple therapy after 26 weeks of treatment.

Start: December 2020

RVA Breathes: A Richmond City Collaboration to Reduce Pediatric Asthma Disparities

The goal of this study is to evaluate a sustainable, community-engaged program to reduce asthma disparities among 5 to 11-year-old children in Richmond, Virginia. Richmond, an urban center, has been named the Asthma Capital, or "most challenging place to live in the U.S. with asthma," by the Asthma and Allergy Foundation three times in the last 5 years. To date, however, the city has no comprehensive, community-engaged asthma care program for those children at highest risk for poor asthma outcomes. To address this disparity, the study team engaged with community partners and completed a mixed-methods needs assessment to enhance understanding of the barriers and supports to asthma care for children and their families living in Richmond. Several key priority areas emerged: peer support, advocacy, treating the home as a system, increased school nurse education, and coordination with schools and providers. Working together, the community-engaged team translated needs assessment findings to RVA Breathes, a program coordinating asthma care across 4 sectors: family, home, community, and medical care.

Start: May 2018

A Study to Test if TEV-48574 is Effective in Relieving Asthma

The primary objective of the study is to evaluate the effect of TEV-48574 compared with placebo on loss of asthma control (LoAC) in adult patients with T2-low and non-T2 severe asthma uncontrolled on inhaled corticosteroids plus long-acting beta-agonists (ICS+LABA). The secondary efficacy objective is to evaluate the effect of TEV-48574 compared with placebo on a range of clinical measures of asthma control. The duration of patient participation in the study is planned to be up to approximately 30 weeks.

Start: August 2020

Measuring the Effect of Dupilumab Treatment on Mucociliary Clearance (MCC) in Subjects With Moderate to Severe Asthma

Single center, randomized, placebo- controlled study to assess change in mucociliary clearance of moderate to severe asthma patients after treatment with dupilumab or placebo.

Start: August 2021

A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild Asthma and in Healthy Volunteers

This is a phase 1, first-in-human (FIH), multi-center, randomized, double-blind, placebo-controlled study of CSL311 in patients with mild asthma. The primary objective of this study is to assess the safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD) of CSL311.

Start: November 2019

Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma

A Regional, Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Severe Uncontrolled Asthma

Start: June 2019

Longitudinal Observational Study of Severe Asthma

Background: - Asthma is a lung condition that causes difficulty breathing and decreased lung function. Some people with asthma have more severe disease symptoms. They may be less responsive to standard treatments such as steroids. Researchers want to compare severe asthmatics with mild or moderate asthmatics or people without asthma over a long period. This information may help identify new treatments for people whose asthma is not well controlled by standard medications. Objectives: - To compare severe asthmatics with mild or moderate asthmatics, and healthy volunteers, to study the progression and outcomes of the disease. Eligibility: Individuals at least 18 years of age who have been diagnosed with asthma for at least 1 year. Healthy volunteers at least 18 years of age. Design: This study will involve an initial visit to the NIH Clinical Center for all participants. Selected participants may be asked to return for repeat visits over a number of years. The test results from participants with asthma will be compared with those from the healthy volunteers. All participants will be screened with a physical exam and medical history. Participants may (but will not necessarily) have the following tests at each visit: Complete medical history and physical exam Blood, urine, sputum, and nasal cell samples Breath tests and heart and lung function tests Six-minute walk test to measure ability to exercise Imaging studies such as chest x-rays, bone density scans, and sinus scans Allergy skin testing Vocal cord exam Overnight sleep study Participants may remain on the study for as long as they are willing to participate and do not develop health problems that will interfere with the study.

Start: March 2013

Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics

The purpose of the study is to evaluate effect of benralizumab on structural and lung function changes in severe eosinophilic asthmatics. Changes will be assessed over 48 week treatment period in patients with persistent symptoms despite standard therapy of inhaled corticosteroids (ICS) plus long acting B2-agonist (LABA) with or without additional controller medication. Patients who complete treatment will enter 4 weeks follow-up period

Start: October 2019

Study in Adult Patients With Moderate to Severe Asthma

The CLI-01535AA02-2 Study is an exploratory study designed to compare two pressurised metered Dose inhalers on subject's perception of asthma symptoms.

Start: November 2021

An Exploratory Study to Characterise Changes in Airway Inflammation, Symptoms, Lung Function and Reliever Use in Adult Asthma Patients

This is a randomised, active-comparator, open-label, parallel-group, multicentre phase IV exploratory study to characterise changes in airway inflammation, symptoms, lung function, and reliever use in asthma patients using SABA (salbutamol) or anti inflammatory reliever (SYMBICORT®) as reliever medication in addition to SYMBICORT as daily asthma controller. Eligible patients diagnosed with asthma at least 6 months prior to the Screening Visit (Visit 1) and fulfilling all of the inclusion criteria and none of the exclusion criteria will continue into the Run-in Period. At Visit 2, patients will be assessed for randomisation criteria and, if met, will be randomised to receive either SYMBICORT as maintenance and reliever treatment or SYMBICORT as maintenance treatment and salbutamol as reliever treatment in a 1:1 ratio. Randomisation will be stratified by the patient's ongoing dose of inhaled corticosteroids [(ICS) low or medium] or long-acting ?2-agonist (ICS/LABA) at study entry.

Start: August 2019

Study to Evaluate the Pharmacokinetics of Tezepelumab in Children With Asthma

This study will evaluate the pharmacokinetic (PK) profile of a single subcutaneous (SC) dose of tezepelumab in children aged ? 5 to 11 years with asthma.

Start: February 2021

A Study to Compare Severe Asthma Patients Who Start Biologics and Who do Not Start (PROSPECT)

Objectives in this study is to compare the change of lung function after 24 months from baseline between the two groups; one is the patient group who decided to start biologics treatment, and another is the patient group who decided to start non-biologics treatment. The target patients are the adult uncontrolled severe asthma patients.

Start: December 2019

The Effect of Dupilumab on Lung Function and Related Changes in Airway Volumes Detectable by Functional Respiratory Imaging in Patients With Moderate-severe Asthma

Primary Objective: o To assess the effect of dupilumab on lung function and related changes in airway volumes detectable by functional respiratory imaging Secondary Objective: To evaluate the effect of dupilumab at Week 24 on bronchodynamics, hyperinflation, airway resistance, airway wall thickness, ventilation defects and mucus plugging derived from high-resolution computed tomography (HRCT) scans, patient-reported outcomes, FeNO and spirometry. To evaluate safety of dupilumab

Start: June 2020

Efficacy and Safety of Three Inhaled Dose Levels of AZD1402 Administered for Four Weeks in Adults With Asthma on Medium Dose Inhaled Corticosteroids

This is a randomised, placebo-controlled, double-blinded, multi-centre, 2-part study to assess the efficacy and safety of inhaled AZD1402. Part 1 will be performed in a lead-in cohort for each dose level to evaluate the safety and pharmacokinetics (PK) in a population with asthma controlled on medium dose inhaled corticosteroids (ICS)-long acting beta agonists (LABA) before progressing to dosing in adults with asthma who are uncontrolled on medium dose ICS-LABA in Part 2. The study will recruit participants receiving treatment with medium dose ICS with LABA for Part 1 (separate inhalers or combination product) and medium dose ICS-LABA as a combination product for Part 2 at Screening. Part 2 will be initiated for each dose level following evaluation of safety and PK at the relevant dose level in Part 1. The entire study period for each participant in both Parts 1 and 2, is approximately 3.5 months; a 2-week Screening Period, a 4 week Run-in Period, 4 weeks of Treatment Period, and 4 weeks of Follow-Up Period.

Start: March 2021