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355 active trials for Asthma

Genetics of the Early and Late Response to Allergen Challenge

The investigators are investigating the early and late responses to allergen challenge. The research participants who the investigators will study (from three cohorts) will be part of independently-approved studies involving allergen challenge. Due to the uniqueness of the cohorts for novel genetic study, it is logical that the investigators should initially undertake hypothesis-generating experiments. The investigators will obtain blood samples from the participants, both pre-challenge and post-challenge. The investigators will determine gene expression and protein differences between these samples, and investigate if there are inherited genetic differences between individuals that may predict their specific responses to allergens.

Start: August 2009

US PRECISION Implementation Study

The primary objective of this community program intervention study is to assess the process and potential benefits of integrating the AIRQ™, Asthma Checklist, and educational resources (PRECISION program) into clinical practice using either in-person or telehealth visits. The secondary objectives are to assess asthma patients' clinic visit experiences when the AIRQ™, the Asthma Checklist, and educational resources (PRECISION program) are utilized as part of a telehealth or in-person visit with their HCP, and to explore change in AIRQ™ scores from the initial visit to follow-up visit(s) (when available).

Start: April 2021

Replication of the D58 Asthma Trial in Healthcare Claims Data

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

Start: October 2020

Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS)

This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care.

Start: March 2021

Managing Asthma Patients With AMAZE™: A Novel Disease Management Platform

The primary study objective is to generate evidence as to the feasibility, usability, perceived value, and potential benefits of implementing the AMAZE™ platform into clinical practice.

Start: April 2021

Evaluating Effects of Curcumin in Moderate to Severe Asthmatics

The purpose of this investigator-initiated study is to evaluate the effects of oral curcumin supplementation versus placebo in adult patients with moderate to severe asthma. Curcumin, a derivative of turmeric, has been shown in animal models to inhibit the secretion of pro-inflammatory cytokines and decrease airway constriction and hyperreactivity with only a few observational studies available in humans with discordant results.

Start: September 2021

Comparative Effectiveness of Telemedicine in Primary Care

Leveraging a natural experiment approach, the investigators will examine rapidly changing telemedicine and in-person models of care during and after the COVID-19 crisis to determine whether certain patients could safely choose to continue telemedicine or telemedicine-supplemented care, rather than return to in-person care.

Start: March 2021

Placebo-controlled Efficacy and Safety Study of GSK3511294 in Participants With Severe Asthma With an Eosinophilic Phenotype

GSK3511294 is being developed as a long-acting (LA) injectable anti-interleukin-5 (anti-IL-5) therapy and is expected to deliver an efficacy and safety profile similar to current anti-IL-5 therapies with a reduced dosing frequency. This study is a multi-center, randomized, placebo-controlled, double-blind, parallel group design and aims to assess the efficacy and safety of GSK3511294 in participants with severe uncontrolled asthma with an eosinophilic phenotype despite standard of care (SoC) treatment with medium to high dose inhaled corticosteroids (ICS) plus at least one additional controller. All participants will receive study intervention as an adjunct therapy while remaining on their existing asthma therapy throughout the study. Assessments will include the annualized rate of clinically significant exacerbations and measures of lung function, asthma control, and safety. Approximately 375 participants will be enrolled in the study.

Start: March 2021

Acute Exacerbations Treated With BenRAlizumab (The ABRA Study)

Exacerbations of asthma and COPD are an important cause of hospital admission and the main cause of annual winter bed shortages. Despite current guideline treatment with prednisolone, 40% of patients require further treatment, 15% are readmitted and, of those hospitalised, 10% die within 3 months, all by definition treatment failures. The investigators have shown that there are two dominant patterns of airway inflammation in patients presenting with an acute episode: infection associated neutrophilic airway inflammation; and non-infection related eosinophilic airway inflammation. These patterns cannot be distinguished reliably by clinical categories (i.e. asthma or COPD) or a standard clinical assessment but are identified by the peripheral blood eosinophil count. These findings raise important questions that targeted treatment based on the blood eosinophil count would result in more efficient and effective management. However, even in patients with the right pattern of airway inflammation the beneficial effects of prednisolone have to be offset against a high potential for harm, with an estimated the number needed to harm as 5 for every 10 patients treated. Benralizumab is an interleukin-5 receptor-? monoclonal antibody, injected subcutaneously, which rapidly reduces peripheral blood eosinophils for 90 days with a satisfactory safety profile. Benralizumab treatment at stable state has been shown to increase post-bronchodilator FEV1 and reduce the rates of severe exacerbations in patients with severe eosinophilic asthma and improve lung function in patients with eosinophilic COPD. Benralizumab is an attractive candidate for the acute treatment of eosinophilic exacerbations, without the side-effects of prednisolone. The investigators propose to test the hypothesis that, for participants who have a raised eosinophil count at exacerbation, a single injection of Benralizumab alone or in combination with prednisolone will improve clinical outcomes compared to prednisolone alone. The investigators will also study the effect of prednisolone on symptoms, lung function and quality of life, in an exacerbation when the eosinophil count is not raised.

Start: March 2021

A Trial of SHR-1905 in Healthy Subjects

This is a randomized, double-blind, placebo-controlled, single dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of subcutaneous administered SHR-1905 in healthy subjects.

Start: June 2021

A Study to Investigate the Safety, Tolerability and Drug Behavior of Inhaled AZD4604 and to Investigate the Anti-inflammatory Effect of AZD4604

This first in human clinical study will assess the safety and tolerability as well as the single dose pharmacokinetics (PK) of inhaled AZD4604 in healthy volunteers (Part 1a, single ascending dose [SAD]). The single dose administration will be performed with nebulized formulation of AZD4604. Following completion of the first 4 SAD cohorts, one dose level will be repeated with a dry powder inhaler (DPI) formulation (DPI Cohort), bridging PK and safety. When at least 4 cohorts of the SAD part of the study have been completed, AZD4604 will be administered as a single intravenous (IV) or single oral (PO) dose to 2 different cohorts of healthy volunteers (Part 1b). The main purpose is to compare the PK between IV and inhaled administration as well as between oral and inhaled administration to further characterize the PK properties of AZD4604 by the various administration routes. The results will be used to improve future study design and interpretation.

Start: September 2021

Stem Cell Strategies for the Treatment of Chronic Asthma

The study is a pilot/laboratory study comparing the effects of MSC conditioned media on samples of airway cells in 3 participant groups with mild/moderate asthma (5 participants), severe asthma (5 participants), or no asthma (5 participants).

Start: August 2016

A Trial of SHR-1703 in Healthy Subjects

This is a randomized, double-blind, placebo-controlled, single dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics pharmacodynamics and immunogenicity of subcutaneous administered SHR-1703 in healthy subjects.

Start: June 2021

A Randomized Controlled Trial of AppS to Home Monitor Your Asthma

The objective of this study is to design, implement, and evaluate the impact of an adapted health information technology(IT)-enabled practice model for asthma symptom monitoring using patient-reported outcomes (PROs) in a primary care setting. Adults over 18 years of age with asthma will be recruited at four primary care clinics and randomized to either 1) asthma symptom monitoring via the mobile health (mHealth) app; or 2) usual care. The investigators will collect data on patient-reported asthma quality of life and asthma-related healthcare utilization. We will also study barriers and facilitators to implementation of the mHealth app and health IT-enabled practice model.

Start: July 2020

A 12-Week Treatment Study to Evaluate the Effectiveness of Albuterol Multidose Dry Powder Inhaler With Integrated Electronic Module Digital System (eMDPI DS) in Patients 13 Years or Older With Asthma

This is a 12-week treatment, multicenter, open-label, randomized, parallel group comparison feasibility study to evaluate the effectiveness of the Albuterol eMDPI Digital System (DS), including inhaler, App, DHP (Cloud solution), and dashboard, to optimize outcomes in patients at least 13 years of age or older with asthma. The study will consist of a screening visit, a 12-week open-label treatment period, and a follow-up telephone call (2 weeks following treatment completion). Patients with suboptimal asthma control will be enrolled in the study and randomized in a 1:1 ratio to 1 of 2 parallel groups stratified by investigational center: DS group patients utilizing the Albuterol eMDPI DS, including inhaler, App, DHP (Cloud solution), and dashboard, and CC group patients who will be treated with their standard of care albuterol-administering rescue inhalers and will not use the DS during the treatment period.

Start: October 2020

Aggravated Airway Inflammation: Research on Genomics and Optimal Operative Treatment (AirGOs Operative)

This randomized study compares operative techniques in chronic rhinosinusitis with polyposis (CRSwNP) surgery. It aims to evaluate outcomes in asthma and CRSwNP, safety and costs. The investigators want to see if patients with certain clinical and/or genetic predispositions will benefit from extended surgery. They also aim to find biomarkers for detection and management models for of severe airway inflammation and to further develop markers for progressive disease forms.

Start: October 2018

A Study to Assess the Reduction of Daily Maintenance ICS/LABA Treatment Towards Anti-Inflammatory Reliever Treatment in Patients With Severe Eosinophilic Asthma Treated With Benralizumab

This is a multicentre, randomised, open-label, parallel-group, active-controlled, phase IV study to assess the reduction of daily Symbicort® maintenance to anti-inflammatory reliever treatment only in participants with severe eosinophilic asthma on Fasenra® treatment, while maintaining asthma control.

Start: July 2020

Phosphodiesterase 4 Inhibitor, Roflumilast, and the Effects of Inhibition in Severe Asthma

This study evaluates the effects of roflumilast on restoring response ?2 adrenoreceptor agonists in low T2, obese asthmatics. One group of participants will receive roflumilast for 3 months, while the other will receive a placebo.

Start: January 2019

Observational Study of Characteristics, Treatment and Outcomes With Severe Asthma in the United States (CHRONICLE)

The CHRONICLE Study is a multi-center, non-interventional, prospective cohort study of adults with severe asthma who do not achieve control with high-dose inhaled corticosteroid (ICS) therapy with additional controllers and/or require systemic corticosteroid or monoclonal antibody therapy. Data will be collected from the healthcare provider in a uniform manner for every patient enrolled using an electronic case report form (eCRF). Data will be collected monthly from patients via web-based surveys. Patients will be followed until study discontinuation or the patient withdraws from the study or death, whichever occurs first. The expectation is that patients will be followed for a period of at least 3 years.

Start: February 2018

Registry of Asthma Patients Initiating DUPIXENT®

The primary objective of the study is to characterize the patients who initiate treatment for asthma with DUPIXENT® in a real-world setting. The secondary objectives of the study are: To characterize real-world use patterns of DUPIXENT® for asthma To assess the long-term effectiveness of DUPIXENT® in asthma patients in a real-world setting To assess effectiveness on comorbid type 2 inflammatory conditions in asthma patients treated with DUPIXENT® To collect long-term safety data on study participants in the real-world setting

Start: March 2020