Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)
Recruiting
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
Gender:
All
Ages:
Between 12 years and 80 years
Trial Updated:
11/30/2023
Locations: Research Site, Brownsburg, Indiana +1 locations
Conditions: Asthma
Study to Assess the Efficacy and Safety of Atuliflapon in Moderate-to-Severe Uncontrolled Asthma
Recruiting
This is a randomised, placebo-controlled, double-blind study to assess the efficacy and safety of Atuliflapon administered at multiple dose levels over a 12-week treatment period to adult participants with moderate to severe uncontrolled asthma.
Gender:
All
Ages:
Between 18 years and 80 years
Trial Updated:
11/28/2023
Locations: Research Site, Indianapolis, Indiana
Conditions: Asthma
BURAN: Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging
Recruiting
This study will assess the effects of benralizumab on airway dynamics in severe eosinophilic asthma in terms of quantitative computed tomography (CT)-derived measurements of pulmonary structure and function using the Functional Respiratory Imaging (FRI) platform.
Gender:
All
Ages:
Between 18 years and 70 years
Trial Updated:
11/27/2023
Locations: Research Site, Greenwood, Indiana
Conditions: Asthma
Benralizumab Airway Remodeling Study in Severe Eosinophilic Asthmatics
Recruiting
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.
Gender:
All
Ages:
Between 18 years and 70 years
Trial Updated:
11/27/2023
Locations: Research Site, Indianapolis, Indiana
Conditions: Asthma
A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma
Recruiting
This is a US study comparing the efficacy and safety of BDA MDI [Budesonide/Albuterol Sulfate (BDA) metered dose inhaler (MDI)] with AS [Albuterol Sulfate] MDI, both are administered as needed for up to 12 months.
Gender:
All
Ages:
12 years and above
Trial Updated:
11/22/2023
Locations: Velocity Clinical Research - Valparaiso, Valparaiso, Indiana
Conditions: Asthma
A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Severe Eosinophilic Asthma.
Recruiting
This study will assess the efficacy and safety of dexpramipexole as an adjunctive oral therapy in participants with inadequately controlled asthma with an eosinophilic phenotype and a history of asthma exacerbations.
Gender:
All
Ages:
Between 12 years and 99 years
Trial Updated:
11/17/2023
Locations: Research Site 20001-036, Elwood, Indiana +1 locations
Conditions: Eosinophilic Asthma, Asthma; Eosinophilic, Asthma
Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) Longer Term Follow Up
Recruiting
The overall aims of this protocol are to determine whether prenatal supplementation with vitamin C to pregnant smokers can improve pulmonary function at 10 years of age in their offspring. This is an additional continuation of the Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) trial, to follow the offspring through 10 years of age. The hypothesis for this protocol is an extension of the VCSIP trial that supplemental vitamin C in pregnant smokers can signifi... Read More
Gender:
All
Ages:
Between 6 years and 16 years
Trial Updated:
11/17/2023
Locations: Indiana University, Indianapolis, Indiana
Conditions: Asthma, Pulmonary Function, Wheezing, In Utero Nicotine
A Study to Assess the Effect of Dexpramipexole in Adolescents and Adults With Eosinophilic Asthma
Recruiting
The purpose of this study is to evaluate dexpramipexole as an add-on oral therapy in participants with inadequately controlled eosinophilic asthma to evaluate improvements in lung function, asthma control, and quality of life. In addition, the study will further evaluate the safety and tolerability of dexpramipexole in participants with eosinophilic asthma.
Gender:
All
Ages:
Between 12 years and 99 years
Trial Updated:
11/13/2023
Locations: Research Site 40001-036, Elwood, Indiana
Conditions: Eosinophilic Asthma, Asthma; Eosinophilic, Asthma Attack
Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS)
Recruiting
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.
Gender:
All
Ages:
Between 12 years and 80 years
Trial Updated:
11/13/2023
Locations: Research Site, Evansville, Indiana
Conditions: Asthma
Tezepelumab Efficacy and Safety in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma
Recruiting
A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled 28-week Phase 3 Efficacy and Safety Study of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma
Gender:
All
Ages:
Between 18 years and 80 years
Trial Updated:
11/07/2023
Locations: Research Site, Bloomington, Indiana
Conditions: Asthma
A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype
Recruiting
This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior to maintaining current treatment on the annualized rate of clinically significant exacerbations in participants with severe asthma with an eosinophilic phenotype. Throughout the study, all participants will continue their non-biologic Baseline standard of care (SoC) asthma treatment.
Gender:
All
Ages:
12 years and above
Trial Updated:
11/06/2023
Locations: GSK Investigational Site, Evansville, Indiana
Conditions: Asthma
Vitamin C Supplementation to Pregnant Smokers: Follow-up of 2 Randomized Trials Plus Changes in DNA Methylation
Recruiting
In a randomized clinical trial (RCT) published in JAMA, the investigators have provided evidence that vitamin C supplementation (500 mg daily during pregnancy) ameliorates the effects of maternal smoking during pregnancy on offspring lung function and subsequent incidence of wheeze by 48% through 1 year of age. The investigators are currently completing a second RCT of vitamin C supplementation in pregnant smokers with more robust measures of pulmonary outcomes. The purpose of this ECHO applicat... Read More
Gender:
All
Ages:
Between 6 months and 11 years
Trial Updated:
10/06/2023
Locations: Indiana University, Indianapolis, Indiana
Conditions: Asthma, Wheezing, In Utero Nicotine, Pulmonary Function