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Asthma clinical trials

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NCT ID: NCT05140889 Recruiting - Asthma in Children Clinical Trials

Integrating Deep Learning CT-scan Model, Biological and Clinical Variables to Predict Severity of Asthma in Children

BREATHE
Start date: January 20, 2021
Phase:
Study type: Observational [Patient Registry]

Artificial intelligence (AI) offers substantial opportunities for healthcare, supporting better diagnosis, treatment, prevention and personalized care. Analysis of health images is one of the most promising fields for applying AI in healthcare, contributing to better prediction, diagnosis and treatment of diseases. Deep learning (DL) is currently one of the most powerful machine learning techniques. DL algorithms are able to learn from raw (or with little pre-processing) input data and build by themselves sophisticated abstract feature representations (useful patterns) that enable very accurate task decision making. Recently, DL has shown promising results in assisting lung disease analysis using computed tomography (CT) images. Current severe asthma guidelines recommend high-resolution and multidetector CT as a tool for disease evaluation. CT scans contain prognostic information, as the presence of bronchial wall thickening, air trapping, bronchial luminal narrowing, and bronchiectasis are associated with longer disease duration and disease severity in adults. Only a small number of studies have reported chest CT findings in children with severe asthma, and their relationship to clinical and pathobiological parameters yielded inconsistent results. Thus, to which extent CT scans add prognostic information beyond what can be inferred from clinical and biological data is still unresolved in children. The project is expected to build an DL-severity score to prognoses severe evolution for children with asthma, using a DL model to capture CT scan prognosis information.

NCT ID: NCT05120323 Recruiting - Asthma in Children Clinical Trials

vDOT for Newly Diagnosed Pediatric Asthma

Start date: November 3, 2021
Phase: N/A
Study type: Interventional

The goal of this research study is to compare the impact of video directly observed therapy on inhaler technique accuracy with participants receiving video directly observed therapy vs. participants receiving standard asthma care. Participants will be randomized between the two groups. We will follow up and compare the two groups to see if they have improved asthma control as measured by symptom-free days, higher inhaler technique at 3-month follow up, higher checklist scores on a standardized inhaler technique checklist, higher proportion of days covered (PDC) of their inhaled asthma controller medication, and have fewer acute care visits for asthma.

NCT ID: NCT05118282 Recruiting - Asthma in Children Clinical Trials

A Coping Skills Program for Children With Asthma

Start date: November 14, 2021
Phase: N/A
Study type: Interventional

Uncontrolled asthma in school-aged children is a significant public health problem. Latino children living in low-income contexts are at increased risk for uncontrolled asthma compared to non-Latino white children, and stress is an unaddressed factor in this disparity. Therefore, the purpose of the current study is to test an intervention program that teaches families skills to cope with asthma-related and other sources of stress. Specifically, the study will compare the effects of the combined coping skills + asthma management program with a standard asthma management program in 280 families of Latino children with asthma. The study will also look at why the program may have an effect, and specifically whether the program impacts child coping, parent coping, or family asthma management behaviors. The main hypothesis is that the combined coping skills + asthma management program will improve asthma outcomes more than the standard asthma management program.

NCT ID: NCT05111262 Recruiting - Asthma Clinical Trials

Symptom-driven ICS/LABA Therapy for Patients With Asthma Non-adherent to Daily Maintenance Inhalers

Start date: December 16, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Inhaler nonadherence is a common problem that has been estimated to account for approximately 60% of all asthma-related hospitalizations. Unfortunately, prior interventions to improve inhaler nonadherence have shown a lack of long-term success. This study proposes to assess the problem of non-adherence using a D&I research lens while testing a new inhaler approach to potentially ameliorate the detrimental consequences of maintenance inhaler nonadherence.

NCT ID: NCT05105529 Recruiting - Asthma Clinical Trials

Adaptation to Ozone in Individuals With Asthma/Exercise-induced Bronchoconstriction

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Researchers found that impairments in the cardiopulmonary system caused by acute exposure to ozone were outweighed by repeated exposures to ozone. The goal of this study is to confirm there will be an adaptation similar to what was previously proved but in individuals with asthma and exercise-induced bronchoconstriction (EIB). The purpose is to examine adaptive responses in a randomized cross-over trial in which physically active individuals will perform submaximal exercise on five days in ozone and filtered air exposures separated by a washout period.

NCT ID: NCT05097287 Recruiting - Asthma Clinical Trials

Study Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma

ATLAS
Start date: December 16, 2021
Phase: Phase 4
Study type: Interventional

This is an interventional, randomized, parallel group, treatment, Phase 3b/4, double blind, 2-arm study to assess the effect of dupilumab compared to standard of care therapy on preventing or slowing the rate of lung function decline in adult patients with uncontrolled moderate to severe asthma. The estimated duration is 4±1 weeks of screening and run-in period, followed by a 3-year double blinded treatment period. There will be a post-treatment follow-up (FU) period up to 12 weeks.

NCT ID: NCT05091333 Recruiting - Asthma Clinical Trials

FASENRA Regulatory Postmarketing Surveillance in Korea

Start date: March 11, 2022
Phase:
Study type: Observational

As part of a post approval commitment, the MFDS has requested a study to characterize safety in patients who are treated with FASENRA for severe asthma with an eosinophilic phenotype by physicians in normal clinical practice settings. This study is designed to confirm or assess the known safety profile or identify previously unsuspected adverse reactions and to evaluate the effectiveness of FASENRA under conditions of routine daily medical practice in Korea. This study will provide information on the Korean patient population that is treated with this drug.

NCT ID: NCT05087693 Recruiting - Ozone Air Pollution Clinical Trials

Salbutamol Use in Ozone Air Pollution by People With Asthma and/or Exercise Induced Bronchoconstriction (EIB)

Start date: November 1, 2021
Phase: Phase 4
Study type: Interventional

Salbutamol use is increased in areas with high levels of ozone pollution and the potential consequences of this are not well known. The purpose of this study is to examine the effect of salbutamol on lung function and inflammation in people with asthma and/or EIB exercising in ozone air pollution. To examine this, we are planning a randomized cross over trial where people with asthma and/or EIB complete sub maximal exercise in four conditions on four separate days. The four condition are: ozone + salbutamol, filtered air + salbutamol, ozone + placebo medication, and filtered air + placebo medication.

NCT ID: NCT05078281 Recruiting - Clinical trials for Asthma; Eosinophilic

Patients With Severe Eosinophilic Asthma Treated With Benralizumab

Asthma
Start date: November 1, 2020
Phase:
Study type: Observational

Retrospective, multicenter, routine clinical practice study with consecutive inclusion of adult patients with severe eosinophilic asthma receiving benralizumab treatment.

NCT ID: NCT05078021 Recruiting - Asthma Clinical Trials

Phenotyping Disease Severity in Asthma

Start date: April 21, 2022
Phase:
Study type: Observational

The purpose of this study is to characterize and compare the molecular gene expression profile in endobronchial biopsies and cells recovered in bronchial washings from study subjects who have asthma of varying disease severity and who are on maintenance inhaled corticosteroid (ICS) treatment, with that for healthy control subjects. These studies will produce transcriptomic profiles of gene expression associated with asthma disease severity. The investigators will also culture epithelial cells from study participant endobronchial brushings, including those with asthma of varying disease severity and healthy control subjects, to examine differences in the response to corticosteroids (CS) in vitro. These studies will test whether intrinsic differences exist between the responses to ICS in each group. 60 participants will be recruited with 15 of each mild, moderate and severe asthma as defined by the Global Initiative for Asthma (GINA) guidelines, as well as 15 healthy controls. Participants will undergo an initial visit to obtain informed consent, bloodwork and to assess asthma control using the Asthma Control Questionnaire (ACQ); if >1.5, ICS dose will be increased, as per GINA strategy, for a 2 week 'stabilization' phase. Repeat ACQ, spirometry and sputum induction will be performed at visit 2. Bronchoscopy will be performed at visit 3, 2-4 weeks after visit 2. Mucosal biopsies, bronchial brushings and bronchial washings will be performed and processed as per our prior methods. Mucosal biopsies will be homogenized and processed for RNA, or fixed for later sectioning and histological examination. Biopsy RNA will be assessed for quality and subjected to RNA-sequencing of all human genes (mRNA-seq). Bronchial washing cells will be collected for differential cell counting and mRNA-seq analysis. Bronchial epithelial cells (BECs) from the brushings will be cultured. BECs treated with CS and inflammatory cytokines will allow comparative assessment of BEC responses.