Clinical trials: Moderate to Severe Asthma
Moderate-to-Severe Asthma
Effect of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids
This study will evaluate the safety, tolerability and efficacy of a single dose level of KB003 in subjects with inadequately controlled asthma.
- Trial name
- KB003-04 (NCT01603277)
- Testing
- Anti-GM-CSF Monoclonal Antibody 400mg
- Where
- 70 sites in United States, Australia and 4 more
- Volunteers
- 160 people
- Sponsor
- Humanigen, Inc.
Asthma
Evaluation of SAR440340 and as Combination Therapy With Dupilumab in Moderate-to-Severe Asthma Participants
Primary Objective: To evaluate the effects of SAR440340 with or without dupilumab, compared to placebo, on reducing the incidence of "loss of asthma control" (LOAC) events.
- Trial name
- NCT03387852
- Testing
- SAR440340, Dupilumab, Fluticasone or Fluticasone/salmeterol combination
- Where
- 71 sites in United States, Argentina and 6 more
- Volunteers
- 296 people
- Sponsor
- Sanofi
Asthma
A Study of Omalizumab (Xolair) in Subjects With Moderate to Severe Persistent Asthma (EXTRA)
This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of subcutaneously administered Xolair as add-on therapy for the treatment of subjects aged 12-75 years old…
- Trial name
- NCT00314574
- Testing
- omalizumab (Xolair), corticosteroids, long-acting beta-agonists
- Volunteers
- 850 people
- Sponsor
- Genentech, Inc.
Asthma
A Comparison of SYMBICORT® pMDI With Budesonide HFA pMDI in African American Subjects With Asthma.
The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration, FDA) in the African American population.
- Trial name
- NCT00419952
- Testing
- Budesonide/formoterol (SYMBICORT) pMDI, Budesonide HFA pMDI
- Where
- 122 sites in United States
- Volunteers
- 742 people
- Sponsor
- AstraZeneca
Asthma
Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma
Primary Objective: To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC) once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbation in participants…
- Trial name
- NCT01312961
- Testing
- Dupilumab, Fluticasone/Salmeterol combination therapy, Fluticasone monotherapy
- Where
- 50 sites in United States
- Volunteers
- 104 people
- Sponsor
- Sanofi
Eosinophilic Asthma
Study to Evaluate the Efficacy and Safety of Reslizumab Treatment in Patients With Moderate to Severe Asthma
The primary objective of the study is to characterize the efficacy of reslizumab treatment, at a dosage of 3.0 milligrams per kilogram (mg/kg) every 4 weeks for a total of 4 doses, in improving pulmonary function in relation to…
- Trial name
- NCT01508936
- Testing
- Reslizumab
- Where
- 66 sites in United States
- Volunteers
- 511 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Asthma
GB001 in Adult Subjects With Moderate to Severe Asthma
A randomized, double-blind, placebo-controlled, dose-ranging, multi-center study to evaluate the efficacy and safety of GB001 when added to standard-of care (SOC) asthma maintenance therapy in adults with moderate to severe…
- Trial name
- NCT03683576
- Testing
- GB001
- Where
- 117 sites in United States, Austria and 9 more
- Volunteers
- 481 people
- Sponsor
- GB001, Inc, a wholly owned subsidiary of Gossamer Bio, Inc.
Asthma
AZD1419 Ph2a Study
Ph2a study planned to be run at approximately 16-18 sites in 4 EU countries (Denmark, Hungary, Poland and Sweden) enrolling approximately 170 patients to ensure 70 randomized patients with eosinophilic, moderate to severe asthma.
- Trial name
- INCONTRO (NCT02898662)
- Testing
- AZD1419
- Where
- 15 sites in Denmark, Hungary and 2 more
- Volunteers
- 81 people
- Sponsor
- AstraZeneca
Asthma
The Effect of Dupilumab on Lung Inflammation and Related Changes in Airway Volumes Detectable by Functional Respiratory Imaging in Patients With Moderate-severe Asthma
Primary Objective: To assess the effect of dupilumab on lung inflammation and related changes in airway volumes detectable by functional respiratory imaging Secondary Objective: To evaluate the effect of dupilumab at Week 24 on…
- Trial name
- VESTIGE (NCT04400318)
- Testing
- Dupilumab
- Where
- 65 sites in United States, Bulgaria and 11 more
- Volunteers
- 109 people
- Sponsor
- Sanofi
Asthma, Obesity
Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics (Glitz Asthma)
Asthmatics who are significantly overweight tend to have more severe symptoms, more flare ups, and are more likely to have poorly-controlled asthma when compared to other asthmatics.
- Trial name
- GLITZ (NCT00787644)
- Testing
- Pioglitazone
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- University of Vermont
Moderate to Severe Asthma
Phase I Assessment of Hypertonic Saline in Moderate to Severe Asthmatics
Purpose: To determine if inhaled hypertonic saline (HS) accelerates airway mucociliary clearance (MCC) in well-controlled moderate to severe asthmatics.
- Trial name
- NCT03556683
- Testing
- 3% Hypertonic Saline, 7% Hypertonic Saline, Salbutamol
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- University of North Carolina, Chapel Hill
Asthma
An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma
Primary Objective: To evaluate the efficacy of different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma.
- Trial name
- NCT01854047
- Testing
- Dupilumab, ICS/LABA therapy, Salbutamol/albuterol
- Where
- 201 sites in United States, Argentina and 14 more
- Volunteers
- 776 people
- Sponsor
- Sanofi
Asthma
Evaluation of Tiotropium 2.5 and 5 µg Once Daily Delivered Via the Respimat Inhaler Compared to Placebo in Patient With Moderate to Severe Persistent Asthma
The aim of this trial is to evaluate the safety and efficacy of 2.5 and 5 µg tiotropium over a 52-week treatment period as compared to placebo.
- Trial name
- NCT01340209
- Testing
- Tiotropium Respimat
- Where
- 55 sites in Japan
- Volunteers
- 285 people
- Sponsor
- Boehringer Ingelheim
Asthma
Pilot Study of Pioglitazone for the Treatment of Moderate to Severe Asthma in Obese Asthmatics
Asthmatics who are significantly overweight tend to have more severe symptoms, more flare ups, and are more likely to have poorly-controlled asthma when compared to other asthmatics.
- Trial name
- GLITZ Asthma (NCT00634036)
- Testing
- pioglitazone
- Where
- 2 sites in United States
- Volunteers
- 23 people
- Sponsor
- Fernando Holguin
Asthma
Study in Adult Patients With Moderate to Severe Asthma
This study assessed the influence of pink vs. white pressurized metered-dose inhaler (pMDI) actuators on asthma symptoms perception. There was no prespecified primary objective.
- Trial name
- FEEL (NCT04886999)
- Testing
- Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler A), Beclomethasone dipropionate 100 µg / Formoterol fumarate 6 µg (Inhaler B)
- Where
- 10 sites in Italy
- Volunteers
- 78 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma, GERD
Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma
The purpose of this study is to determine whether treatment with esomeprazole for 6 months will improve asthma in adult patients with moderate to severe asthma and symptoms of gastroesophageal reflux disease.
- Trial name
- RELAX (NCT00317044)
- Testing
- Esomeprazole
- Where
- 130 sites in United States, Argentina and 12 more
- Volunteers
- 961 people
- Sponsor
- AstraZeneca
Asthma (Part 1), COPD (Part 2)
Two-part Safety, Tolerability, Pharmacodynamic and -Kinetic Study of Inhaled AZD8871 in Asthmatic and COPD Subjects
This is a phase I, randomised, placebo-controlled 2-part study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD8871 delivered by inhalation, in asthmatic and chronic obstructive pulmonary disease…
- Trial name
- NCT02573155
- Testing
- Dose 1, AZD8871 50 μg (Part 1), Dose 2, AZD8871 100 μg (Part 1), Dose 3, AZD8871 300 μg (Part 1)
- Where
- 2 sites in United Kingdom
- Volunteers
- 134 people
- Sponsor
- AstraZeneca
Asthma
A Study to Evaluate the Effect of Dupilumab on Exercise Capacity in Adult Patients With Asthma
The primary objective of the study is to demonstrate that dupilumab treatment improves exercise capacity in patients with moderate-to-severe asthma.
- Trial name
- NCT04203797
- Testing
- dupilumab
- Where
- 30 sites in United States, France and 3 more
- Volunteers
- 40 people
- Sponsor
- Regeneron Pharmaceuticals
Allergic Asthma
Efficacy of Omalizumab in Adults (18-60 Years of Age) With Moderate-Severe, Persistent Allergic Asthma, Despite Receiving Inhaled Corticosteroids and Long Acting Beta-agonists
This study aims to investigate the effect of omalizumab on the number of tissue eosinophils and other markers of airway inflammation and remodeling, including thickness of the lamina reticularis, in moderate to severe asthmatics…
- Trial name
- eXplore (NCT00670930)
- Testing
- omalizumab at a dose of 0.016mg/kg/IU/mL
- Where
- 16 sites in United States, Canada and 5 more
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
Preschool Wheeze: Inflammation/Infection Guided Management
This is a single-centre, randomised-controlled trial, comparing management of preschool wheeze. It specifically aims to compare management of preschool wheeze using current clinical guidelines to management determined by…
- Trial name
- PrIGMa (NCT02517099)
- Testing
- Beclometasone, Co-amoxiclav, Azithromycin
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- Imperial College London