Functional Lung MRI for Early Treatment Response Assessment for Patients With Eosinophilic Asthma
NCT ID: NCT04512521
Last Updated: 2023-03-10
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
UNKNOWN
Total Enrollment
40 participants
Study Classification
OBSERVATIONAL
Study Start Date
2020-05-04
Study Completion Date
2025-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Patients with severe eosinophilic asthma will be placed on biologics if they continue to be uncontrolled despite maximized inhalation therapy or if they are only controlled under oral corticosteroids. Among biologics, 80% of patients respond to treatment and improve clinically, but approximately 20% are non-responders and up to date no established predictive factors for treatment response exist. Among the responders, about 30% respond very well (so-called super responders), the rest shows moderate improvements. As the lung function, one main criterion to evaluate treatment response improves in most patients with delay, the response (or non-response) to treatment can only be reliably estimated after 4 to 12 months. This can lead to prolonged use of medication in non-responders (overtreatment) on one hand and to unjustified and premature termination of therapy (undertreatment) on the other hand (GINA report 2019).
Functional lung MRI has the potential to show early changes in lung microstructure, regional ventilation and perfusion and thus has the potential for early detection of therapy response. Very promising results of dynamic regional ventilation and perfusion mapping using phase resolved functional lung (PREFUL) MRI have been shown recently.
However, if functional lung MRI can reliably detect treatment effects under Mepolizumab therapy and can help to predict a long-term patient outcome is still unknown. As these findings could directly influence clinical decision making this question is of high clinical relevance.
Functional lung MRI has the potential to show early changes in lung microstructure, regional ventilation and perfusion and thus has the potential for early detection of therapy response. Very promising results of dynamic regional ventilation and perfusion mapping using phase resolved functional lung (PREFUL) MRI have been shown recently.
However, if functional lung MRI can reliably detect treatment effects under Mepolizumab therapy and can help to predict a long-term patient outcome is still unknown. As these findings could directly influence clinical decision making this question is of high clinical relevance.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Dose Ranging Pharmacokinetics and Pharmacodynamics Study With Mepolizumab in Asthma Patients With Elevated Eosinophils
NCT01366521
Asthma
COMPLETED
PHASE2
Effect of Mepolizumab on Severe Eosinophilic Asthma
NCT04641741
Asthma
Eosinophilic Asthma
UNKNOWN
Efficacy of Mepolizumab in Severe Asthmatics on a Long Term (MESILICO)
NCT04612556
Asthma; Eosinophilic
Severe Asthma
Late-Onset Asthma
ACTIVE_NOT_RECRUITING
Exploring Asthma Exacerbations in Mepolizumab Treated Patients
NCT03324230
Asthma Brittle
COMPLETED
Effects of Mepolizumab Compared to Placebo on Airway Physiology in Patients With Eosinophilic Asthma: MEMORY Study
NCT02594332
Asthma
TERMINATED
PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Asthma is a chronic disease and affects approximately 300 million people worldwide. Of these patients 3-10% have severe asthma which is defined as asthma remaining uncontrolled despite treatment with high-dose inhaled glucocorticoids combined with other controllers (long-acting β2-agonist, long-acting antimuscarinic agent, leukotriene receptor antagonist or theophylline) and/or treatment with systemic glucocorticoids for at least 6 months. Severe asthma causes a high amount of medical expenses in asthma. For patients suffering from severe uncontrolled asthma, an IL-5 antibody (mepolizumab) has been approved for therapy when a type 2 inflammation was present. Treatment is well tolerated and a significant reduction of exacerbations, oral glucocorticoid use was reported. Another IL-5 antibody (reslizumab) and an IL-5 receptor antibody (benralizumab) are available now.
Patients with severe eosinophilic asthma will be placed on biologics if they continue to be uncontrolled under maximal therapy or if they are only controlled under oral corticosteroids. Among biologics, 80% of patients improve, 20% are non-responders, but there is no way to identify them early. Among the responders, about 30% respond very well (so-called super responders), the rest shows moderate improvements. The main problems at the moment are that lung function improvements are only delayed, the response (or non-response) can only be reliably estimated after 4 to 12 months. This leads on the one hand to prolonged use of medication in non-responders (overtreatment), on the other hand to unjustified and premature termination of therapy (undertreatment) (GINA report 2019).
Study Rationale Functional lung MRI has the potential to show early changes in lung microstructure, regional ventilation and perfusion and thus has the potential for early detection of therapy response. Very promising results of dynamic regional ventilation and perfusion mapping using phase resolved functional lung (PREFUL) MRI have been shown recently. This technique holds the promise to mature into a patient friendly sensitive MRI spirometry test, with novel clinically relevant information to guide clinical decision making and improve patient monitoring. PREFUL MRI typically uses standard 1.5T or 3T MRI equipment and is based on a routine gradient echo fast low angle shot (FLASH) sequence. PREFUL is well suited also for children, because it is a free breathing exam without the need for i.v. contrast and has a relatively short examination time. The ventilation, perfusion and dynamic flow-volume loop maps are reconstructed entirely after the image acquisition using complex registration and post processing algorithms developed and validated at Hannover Medical School. Preliminary unpublished data show that PREFUL MRI may detect changes in regional ventilation 3 months after anti IL 5 antibody therapy treatment.
However, if functional lung MRI can reliably detect changes at 3 months of Mepolizumab treatment and can predict long term patient outcome is still unknown, which is of high clinical relevance for future clinical decision making.
The aim of this study is to examine if early treatment changes of Mepolizumab treatment can be detected at 3 months measured by functional lung MRI and predict clinical outcome at 12 months of treatment.
Patients with severe eosinophilic asthma will be placed on biologics if they continue to be uncontrolled under maximal therapy or if they are only controlled under oral corticosteroids. Among biologics, 80% of patients improve, 20% are non-responders, but there is no way to identify them early. Among the responders, about 30% respond very well (so-called super responders), the rest shows moderate improvements. The main problems at the moment are that lung function improvements are only delayed, the response (or non-response) can only be reliably estimated after 4 to 12 months. This leads on the one hand to prolonged use of medication in non-responders (overtreatment), on the other hand to unjustified and premature termination of therapy (undertreatment) (GINA report 2019).
Study Rationale Functional lung MRI has the potential to show early changes in lung microstructure, regional ventilation and perfusion and thus has the potential for early detection of therapy response. Very promising results of dynamic regional ventilation and perfusion mapping using phase resolved functional lung (PREFUL) MRI have been shown recently. This technique holds the promise to mature into a patient friendly sensitive MRI spirometry test, with novel clinically relevant information to guide clinical decision making and improve patient monitoring. PREFUL MRI typically uses standard 1.5T or 3T MRI equipment and is based on a routine gradient echo fast low angle shot (FLASH) sequence. PREFUL is well suited also for children, because it is a free breathing exam without the need for i.v. contrast and has a relatively short examination time. The ventilation, perfusion and dynamic flow-volume loop maps are reconstructed entirely after the image acquisition using complex registration and post processing algorithms developed and validated at Hannover Medical School. Preliminary unpublished data show that PREFUL MRI may detect changes in regional ventilation 3 months after anti IL 5 antibody therapy treatment.
However, if functional lung MRI can reliably detect changes at 3 months of Mepolizumab treatment and can predict long term patient outcome is still unknown, which is of high clinical relevance for future clinical decision making.
The aim of this study is to examine if early treatment changes of Mepolizumab treatment can be detected at 3 months measured by functional lung MRI and predict clinical outcome at 12 months of treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Asthma; Eosinophilic
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
eosinophilic asthma
Mepolizumab
Intervention Type
DRUG
Mepolizumab therapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mepolizumab
Mepolizumab therapy
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Able and willing to give written informed consent.
* Male and female subjects, aged ≥ 18 years.
* Patients which are eligible for treatment using anti-IL-5 -antibody treatment following guidelines: severe eosinophilic asthma and blood eosinophils of ≥150 cells/μL at screening or ≥ 300 cells/μL within 12 months prior to treatment
* Physician-diagnosed severe asthma according to ERS/ATS guidelines
* Treatment with a total daily dose of medium or high-dose ICS (e.g. ≥ 500μg fluticasone propionate, ≥ 800μg budesonide or equivalent total daily dose). ICS can be contained within an ICS/LABA combination product.
* At least one additional maintenance asthma controller e.g. LABA, LTRA, theophylline, LAMA, etc. with or without OCS
* Male and female subjects, aged ≥ 18 years.
* Patients which are eligible for treatment using anti-IL-5 -antibody treatment following guidelines: severe eosinophilic asthma and blood eosinophils of ≥150 cells/μL at screening or ≥ 300 cells/μL within 12 months prior to treatment
* Physician-diagnosed severe asthma according to ERS/ATS guidelines
* Treatment with a total daily dose of medium or high-dose ICS (e.g. ≥ 500μg fluticasone propionate, ≥ 800μg budesonide or equivalent total daily dose). ICS can be contained within an ICS/LABA combination product.
* At least one additional maintenance asthma controller e.g. LABA, LTRA, theophylline, LAMA, etc. with or without OCS
Exclusion Criteria
* Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs, lung function at screening visit, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study.
* Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease other than Asthma (including but not confined to tuberculosis, bronchiectasis, cystic fibrosis, pulmonary hypertension, sarcoidosis, interstitial lung disease or lung fibrosis).
* History of drug or alcohol abuse.
* Risk of non-compliance with study procedures.
* Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
* History of an acute respiratory infection four weeks prior to enrolment. These patients will not be eligible, but will be permitted to be rescreened 4 weeks after the resolution of the respiratory tract infection.
* Subjects with severe renal impairment (GFR ≤ 30 mL/min) including those with end-stage renal disease requiring dialysis or urinary retention.
* Subjects with active/ clinical history of COPD.
* Subjects unable to undergo MRI scans, including claustrophobia or presence of any metal objects within the patient, preventing from MRI scan (e.g. pacemaker, aneurysm clips).
* History of asthma exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization within 3 months prior to enrolment.
* Subjects with a body mass index (BMI) of more than 35 kg/m2.
* Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease other than Asthma (including but not confined to tuberculosis, bronchiectasis, cystic fibrosis, pulmonary hypertension, sarcoidosis, interstitial lung disease or lung fibrosis).
* History of drug or alcohol abuse.
* Risk of non-compliance with study procedures.
* Suspected inability to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study.
* History of an acute respiratory infection four weeks prior to enrolment. These patients will not be eligible, but will be permitted to be rescreened 4 weeks after the resolution of the respiratory tract infection.
* Subjects with severe renal impairment (GFR ≤ 30 mL/min) including those with end-stage renal disease requiring dialysis or urinary retention.
* Subjects with active/ clinical history of COPD.
* Subjects unable to undergo MRI scans, including claustrophobia or presence of any metal objects within the patient, preventing from MRI scan (e.g. pacemaker, aneurysm clips).
* History of asthma exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization within 3 months prior to enrolment.
* Subjects with a body mass index (BMI) of more than 35 kg/m2.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Sponsor Role
collaborator
Hannover Medical School
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jens Vogel-Claussen, MD
Role: PRINCIPAL_INVESTIGATOR
Hannover Medical School
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hannover Medical School
Hanover, Lower Saxony, Germany
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Germany
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
To T, Stanojevic S, Moores G, Gershon AS, Bateman ED, Cruz AA, Boulet LP. Global asthma prevalence in adults: findings from the cross-sectional world health survey. BMC Public Health. 2012 Mar 19;12:204. doi: 10.1186/1471-2458-12-204.
Reference Type
BACKGROUND
Hekking PW, Wener RR, Amelink M, Zwinderman AH, Bouvy ML, Bel EH. The prevalence of severe refractory asthma. J Allergy Clin Immunol. 2015 Apr;135(4):896-902. doi: 10.1016/j.jaci.2014.08.042. Epub 2014 Oct 16.
Reference Type
BACKGROUND
Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, Adcock IM, Bateman ED, Bel EH, Bleecker ER, Boulet LP, Brightling C, Chanez P, Dahlen SE, Djukanovic R, Frey U, Gaga M, Gibson P, Hamid Q, Jajour NN, Mauad T, Sorkness RL, Teague WG. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014 Feb;43(2):343-73. doi: 10.1183/09031936.00202013. Epub 2013 Dec 12.
Reference Type
BACKGROUND
Braman SS. The global burden of asthma. Chest. 2006 Jul;130(1 Suppl):4S-12S. doi: 10.1378/chest.130.1_suppl.4S.
Reference Type
BACKGROUND
Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON, Ortega H, Chanez P. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012 Aug 18;380(9842):651-9. doi: 10.1016/S0140-6736(12)60988-X.
Reference Type
BACKGROUND
Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2015 Apr 30;372(18):1777. doi: 10.1056/NEJMx150017. Epub 2015 Apr 10. No abstract available.
Reference Type
BACKGROUND
Bel EH, Wenzel SE, Thompson PJ, Prazma CM, Keene ON, Yancey SW, Ortega HG, Pavord ID; SIRIUS Investigators. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014 Sep 25;371(13):1189-97. doi: 10.1056/NEJMoa1403291. Epub 2014 Sep 8.
Reference Type
BACKGROUND
Castro M, Zangrilli J, Wechsler ME, Bateman ED, Brusselle GG, Bardin P, Murphy K, Maspero JF, O'Brien C, Korn S. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet Respir Med. 2015 May;3(5):355-66. doi: 10.1016/S2213-2600(15)00042-9. Epub 2015 Feb 23.
Reference Type
BACKGROUND
Nair P, Wenzel S, Rabe KF, Bourdin A, Lugogo NL, Kuna P, Barker P, Sproule S, Ponnarambil S, Goldman M; ZONDA Trial Investigators. Oral Glucocorticoid-Sparing Effect of Benralizumab in Severe Asthma. N Engl J Med. 2017 Jun 22;376(25):2448-2458. doi: 10.1056/NEJMoa1703501. Epub 2017 May 22.
Reference Type
BACKGROUND
Voskrebenzev A, Gutberlet M, Klimes F, Kaireit TF, Schonfeld C, Rotarmel A, Wacker F, Vogel-Claussen J. Feasibility of quantitative regional ventilation and perfusion mapping with phase-resolved functional lung (PREFUL) MRI in healthy volunteers and COPD, CTEPH, and CF patients. Magn Reson Med. 2018 Apr;79(4):2306-2314. doi: 10.1002/mrm.26893. Epub 2017 Aug 30.
Reference Type
BACKGROUND
Kaireit TF, Gutberlet M, Voskrebenzev A, Freise J, Welte T, Hohlfeld JM, Wacker F, Vogel-Claussen J. Comparison of quantitative regional ventilation-weighted fourier decomposition MRI with dynamic fluorinated gas washout MRI and lung function testing in COPD patients. J Magn Reson Imaging. 2018 Jun;47(6):1534-1541. doi: 10.1002/jmri.25902. Epub 2017 Nov 21.
Reference Type
BACKGROUND
Kaireit TF, Voskrebenzev A, Gutberlet M, Freise J, Jobst B, Kauczor HU, Welte T, Wacker F, Vogel-Claussen J. Comparison of quantitative regional perfusion-weighted phase resolved functional lung (PREFUL) MRI with dynamic gadolinium-enhanced regional pulmonary perfusion MRI in COPD patients. J Magn Reson Imaging. 2019 Apr;49(4):1122-1132. doi: 10.1002/jmri.26342. Epub 2018 Oct 22.
Reference Type
BACKGROUND
Klimes F, Voskrebenzev A, Gutberlet M, Kern A, Behrendt L, Kaireit TF, Czerner C, Renne J, Wacker F, Vogel-Claussen J. Free-breathing quantification of regional ventilation derived by phase-resolved functional lung (PREFUL) MRI. NMR Biomed. 2019 Jun;32(6):e4088. doi: 10.1002/nbm.4088. Epub 2019 Mar 25.
Reference Type
BACKGROUND
Bauman G, Puderbach M, Deimling M, Jellus V, Chefd'hotel C, Dinkel J, Hintze C, Kauczor HU, Schad LR. Non-contrast-enhanced perfusion and ventilation assessment of the human lung by means of fourier decomposition in proton MRI. Magn Reson Med. 2009 Sep;62(3):656-64. doi: 10.1002/mrm.22031.
Reference Type
BACKGROUND
Moher Alsady T, Voskrebenzev A, Greer M, Becker L, Kaireit TF, Welte T, Wacker F, Gottlieb J, Vogel-Claussen J. MRI-derived regional flow-volume loop parameters detect early-stage chronic lung allograft dysfunction. J Magn Reson Imaging. 2019 Dec;50(6):1873-1882. doi: 10.1002/jmri.26799. Epub 2019 May 27.
Reference Type
BACKGROUND
Svenningsen S, Eddy RL, Lim HF, Cox PG, Nair P, Parraga G. Sputum Eosinophilia and Magnetic Resonance Imaging Ventilation Heterogeneity in Severe Asthma. Am J Respir Crit Care Med. 2018 Apr 1;197(7):876-884. doi: 10.1164/rccm.201709-1948OC.
Reference Type
BACKGROUND
Gutberlet M, Kaireit TF, Voskrebenzev A, Lasch F, Freise J, Welte T, Wacker F, Hohlfeld JM, Vogel-Claussen J. Free-breathing Dynamic 19F Gas MR Imaging for Mapping of Regional Lung Ventilation in Patients with COPD. Radiology. 2018 Mar;286(3):1040-1051. doi: 10.1148/radiol.2017170591. Epub 2017 Oct 3.
Reference Type
BACKGROUND
Couch MJ, Ball IK, Li T, Fox MS, Biman B, Albert MS. 19 F MRI of the Lungs Using Inert Fluorinated Gases: Challenges and New Developments. J Magn Reson Imaging. 2019 Feb;49(2):343-354. doi: 10.1002/jmri.26292. Epub 2018 Sep 24.
Reference Type
BACKGROUND
Horn FC, Marshall H, Collier GJ, Kay R, Siddiqui S, Brightling CE, Parra-Robles J, Wild JM. Regional Ventilation Changes in the Lung: Treatment Response Mapping by Using Hyperpolarized Gas MR Imaging as a Quantitative Biomarker. Radiology. 2017 Sep;284(3):854-861. doi: 10.1148/radiol.2017160532. Epub 2017 May 4.
Reference Type
BACKGROUND
Capaldi DPI, Sheikh K, Eddy RL, Guo F, Svenningsen S, Nair P, McCormack DG, Parraga G; Canadian Respiratory Research Network. Free-breathing Functional Pulmonary MRI: Response to Bronchodilator and Bronchoprovocation in Severe Asthma. Acad Radiol. 2017 Oct;24(10):1268-1276. doi: 10.1016/j.acra.2017.04.012. Epub 2017 May 24.
Reference Type
BACKGROUND
Svenningsen S, Kirby M, Starr D, Leary D, Wheatley A, Maksym GN, McCormack DG, Parraga G. Hyperpolarized (3) He and (129) Xe MRI: differences in asthma before bronchodilation. J Magn Reson Imaging. 2013 Dec;38(6):1521-30. doi: 10.1002/jmri.24111. Epub 2013 Apr 15.
Reference Type
BACKGROUND
Vogel-Claussen J, Schonfeld CO, Kaireit TF, Voskrebenzev A, Czerner CP, Renne J, Tillmann HC, Berschneider K, Hiltl S, Bauersachs J, Welte T, Hohlfeld JM. Effect of Indacaterol/Glycopyrronium on Pulmonary Perfusion and Ventilation in Hyperinflated Patients with Chronic Obstructive Pulmonary Disease (CLAIM). A Double-Blind, Randomized, Crossover Trial. Am J Respir Crit Care Med. 2019 May 1;199(9):1086-1096. doi: 10.1164/rccm.201805-0995OC.
Reference Type
BACKGROUND
Hueper K, Parikh MA, Prince MR, Schoenfeld C, Liu C, Bluemke DA, Dashnaw SM, Goldstein TA, Hoffman EA, Lima JA, Skrok J, Zheng J, Barr RG, Vogel-Claussen J. Quantitative and semiquantitative measures of regional pulmonary microvascular perfusion by magnetic resonance imaging and their relationships to global lung perfusion and lung diffusing capacity: the multiethnic study of atherosclerosis chronic obstructive pulmonary disease study. Invest Radiol. 2013 Apr;48(4):223-30. doi: 10.1097/RLI.0b013e318281057d.
Reference Type
BACKGROUND
Eddy RL, Svenningsen S, McCormack DG, Parraga G. What is the minimal clinically important difference for helium-3 magnetic resonance imaging ventilation defects? Eur Respir J. 2018 Jun 28;51(6):1800324. doi: 10.1183/13993003.00324-2018. Print 2018 Jun. No abstract available.
Reference Type
BACKGROUND
Drick N, Seeliger B, Welte T, Fuge J, Suhling H. Anti-IL-5 therapy in patients with severe eosinophilic asthma - clinical efficacy and possible criteria for treatment response. BMC Pulm Med. 2018 Jul 18;18(1):119. doi: 10.1186/s12890-018-0689-2.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
213598
Identifier Type: OTHER
Identifier Source: secondary_id
8832_BO_S_2020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
A Non-interventional, Prospective Study With Benralizumab
NCT06422078
RECRUITING
Response of FeNO, Small Airway Dysfunction and Lung Heterogeneity to 2-week Montelukast Treatment in Asthmatic Children.
NCT01581710
COMPLETED
NA
REACT - REAl Care for AsThma - A Disease Study to Identify Patients With Severe Uncontrolled Asthma
NCT06299306
TERMINATED
Effect of Anti-interleukin 5 (IL5) Therapy on Sputum Cells and Cytokines
NCT04412044
COMPLETED
PHASE4
Investigation to Identify Predictors of Response to a Treatment With Montelukast
NCT00721240
COMPLETED
PHASE4
Towards Targeting the ORigin of the Inflammatory Cascade in Allergic Asthma
NCT04264377
UNKNOWN
Epigenetic Regulation of Exercise Induced Asthma
NCT05174689
UNKNOWN
NA
Change in Patient-Reported Outcomes in Severe Eosinophilic Asthma Patients Treated With Benralizumab Under Real-life Conditions
NCT04184284
COMPLETED
Study to Assess Bronchospasm Potentially Induced by Next-Generation Propellant vs HFA Propellant in an MDI in Participants With Well/Partially Controlled Asthma
NCT05850494
COMPLETED
PHASE3
Imaging Study of the Lungs During an Allergic Asthma Attack
NCT01547286
COMPLETED
NA
Evaluating the Effect of Benralizumab in Severe, Poorly-controlled Eosinophilic Asthma Using Inhaled Hyperpolarized 129-Xenon MRI
NCT03733535
ACTIVE_NOT_RECRUITING
NA
Asthma Control, Quality of Life and Emotional Feelings in a Real Life Setting
NCT02640742
COMPLETED
Effect of Mepolizumab on Decrease of Systemic Corticosteroids in Patients With Severe Eosinophilic Asthma
NCT03453021
COMPLETED
BURAN: Benralizumab on Airway Dynamics in Severe Eosinophilic Asthma Using Functional Respiratory Imaging
NCT05552508
COMPLETED
PHASE4
Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients With Bronchial Asthma (20 to 71 y) (APTA-2217-07)
NCT00246922
COMPLETED
PHASE3
Induction of Allergen Specific Bronchial Immunotolerance After Specific Immunotherapy
NCT01479205
COMPLETED
CT Air-trapping for the Early Identification of Benralizumab Responders Among Eosinophilic Asthma Patients
NCT03976310
COMPLETED
NA
Response and Remission to Treatment With Anti-IL5/IL5R Antagonists
NCT06348173
COMPLETED
Poor Response to Monoclonal Therapy in Asthma
NCT04114396
UNKNOWN
Adult Arm of DZL All Age Asthma Cohort (ALLIANCE)
NCT02419274
RECRUITING
Ventilatory Heterogeneity in Participants With Asthma (MK-0476-513)
NCT01621386
COMPLETED
PHASE1
Phenotypic and Functional Characterization of Neutrophils and Eosinophils in Severe Asthma Treated With Biotherapy
NCT05972213
RECRUITING
Evaluation of Triple Therapy Using Magnetic Resonance Imaging in Asthma
NCT04651777
ACTIVE_NOT_RECRUITING
PHASE3
TNF Alpha in Refractory Asthma
NCT00276029
COMPLETED
NA
Impact of Benralizumab Treatment on Circulating Dendritic Cells in Patients With Eosinophilic Asthma
NCT03652376
UNKNOWN
PHASE4