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Asthma clinical trials

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NCT ID: NCT06014840 Withdrawn - Asthma Clinical Trials

The UCAP 2 Pilot Study

Start date: September 2023
Phase: N/A
Study type: Interventional

Our research group has found that Canadians with undiagnosed asthma or chronic obstructive pulmonary disease (COPD) have increased respiratory symptoms and worse health-related quality of life. The investigators recently developed and validated an on-line questionnaire to accurately identify these symptomatic, undiagnosed individuals. The investigators will advertise in the community asking individuals to complete the on-line questionnaire at home, at their leisure, to determine if they are at risk of asthma or COPD. Those at risk will be invited to participate in our randomized, controlled clinical trial to determine if guidelines-based treatment of newly discovered undiagnosed asthma or COPD will improve their quality of life and clinical outcomes.

NCT ID: NCT06005506 Completed - Adhd Clinical Trials

National Multicenter Interventional Study Aimed at Evaluating the Effect on the Intestinal Microbiota in Chronically Frail Patients Who Share Alterations in Intestinal Function.

sPATIALS3
Start date: October 1, 2021
Phase: N/A
Study type: Interventional

The objective of the study will be to understand whether a supplementation of the diet with an active symbiotic, i.e. characterized by a mix of probiotics and a specially selected fiber with prebiotic activity combined with a vegetable extract with beneficial activities on carbohydrate and lipid metabolism, can reduce the relative inflammatory potential and improve absorption, intestinal motility and bowel habit of patients with various pathological conditions, such as ALS, ADHD and bronchial asthma.

NCT ID: NCT06003569 Recruiting - Asthma in Children Clinical Trials

Reducing Asthma Attacks in Disadvantaged School Children With Asthma

Start date: September 21, 2023
Phase: N/A
Study type: Interventional

Our UH3 clinical trial, "Reducing Asthma Attacks in Disadvantaged School Children with Asthma," seeks broad-scale implementation of our effective school-based approach to improve asthma disparities for children, ages 5-12 years, in low-income communities. The investigators will contextualize dissemination and implementation (D&I) of our Colorado school-based asthma program (Col-SBAP) that reduces asthma exacerbations and missed school days, while also addressing social determinants of health. Our Better Asthma Control for Kids (BACK) Program will evaluate key metrics identified by diverse stakeholders during this dissemination trial in rural and small metropolitan areas of Colorado. Our clinical trial includes two implementation strategies: our standard Col-SBAP, titled BACK-Standard (BACK-S) and an enhanced community-centered approach, titled Back-Enhanced (BACK-E). These two strategies are designed for sustainable delivery by school asthma navigators and school nurses who coordinate with primary care and community resources. The Exploration, Preparation, Implementation, Sustainment (EPIS) D&I framework was applied with community partners during the UG3 planning phase to tailor implementation plans that meet local community needs, resources and priorities (EPIS Phases 1 & 2). BACK-S and BACK-E will be delivered from years 1-3 with data collection for implementation and effectiveness outcomes in 4 Colorado regions. In year 4, the investigators will collect data for sustainment outcomes (EPIS phase 3). The investigators will apply the work from EPIS phases 1-3 to refine our "dissemination playbook" that guides adoption by other school systems (EPIS Phase 4). Our primary implementation hypothesis is: Reach will be greater among students when delivered using the BACK-E arm as compared to BACK-S. Our effectiveness hypothesis is: BACK will be more effective than usual care at reducing asthma exacerbations. The BACK playbook includes training materials and a calculation of return on investment. The investigators are targeting schools with high levels of uncontrolled asthma and asthma associated burden. Our UH3 trial includes partner engagement to ensure BACK is disseminated to diverse geopolitical areas of Colorado with attention to sustainability. Collectively, our approach will accelerate dissemination of BACK nationally to communities experiencing health inequities in pediatric asthma care.

NCT ID: NCT05999032 Not yet recruiting - Pediatric Asthma Clinical Trials

The Puerto Rico Asthma Integrated Response Program ("PR-AIR")

PR-AIR
Start date: October 1, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to adapt and deliver an evidence-based multi-level intervention to reduce asthma disparities, and that promote and improve population health in the high-burden communities of San Juan, Puerto Rico. The Puerto Rico-Asthma Integrated Response Program (PR-AIR) will be implemented and evaluated to address pediatric asthma disparities in San Juan, PR, an area of high asthma burden. This study unfolds in two phases: In Phase 1, the researchers will collaborate with community stakeholders to identify needs, barriers and facilitators of PR-AIR implementation. Phase 2 consists of an evaluation of low-intensity (virtual) and high-intensity (in-person) methods of PR-AIR implementation outcomes using the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework and a mixed methods approach.

NCT ID: NCT05992519 Recruiting - Asthma Clinical Trials

Diagnostic and Translational Values of Point-of-care Blood Eosinophils and Exhaled Nitric Oxide (FeNO) in People Referred by Primary Care for Suspected Asthma

DIVE
Start date: November 7, 2022
Phase:
Study type: Observational

Asthma is characterised by episodic symptoms (attacks) caused by airway inflammation and decreased airflow to the lungs. It affects 10% of the Canadian population and is the most common chronic disease in childhood. Despite its burden and its potential to be life-threatening, establishing the diagnosis takes time due to difficulty in accessing specialised breathing tests. Indeed, the current diagnostic strategy relies on a breathing test (spirometry) and, if non-diagnostic, a subsequent more complicated breathing test conducted in hospitals (a bronchial provocation test). Our dependence on the latter test must be confronted to the bottleneck created by our reliance on it and the difficulty to do these tests in children. Furthermore, within the current framework, people receiving a diagnosis do not know if they have active airway inflammation - a key feature with predicts increased susceptibility to asthma attacks and treatment responsiveness. Our study's goal is to validate clinically accessible and useful diagnostic tests for peoplesuspected to have asthma. Specifically, we are interested in alternative tests that are a) achievable outside the hospital; b) useful markers of airway inflammation/risk c) can identify people at with a higher likelihood of responding to anti-inflammatory therapy. The two tests we are mainly interested in are: - Exhaled nitric oxide (measured with a portable handheld machine) - The blood eosinophil count (obtained on a general blood test) +/- Other tests which we might be able to develop within this cohort (e.g. urine tests)

NCT ID: NCT05992389 Recruiting - Asthma in Children Clinical Trials

Evidence Driven Indoor Air Quality Improvement

Start date: April 3, 2023
Phase:
Study type: Observational

The aim is to identify the underlying disease mechanisms driving specific asthma phenotypes as well as certain disease outcomes and their relation to impaired indoor air quality. This may also help in underpinning specific target mechanisms in order to personalize and improve current treatment options in childhood asthma and develop more successful prevention strategies. This will be done by combining data from detailed clinical phenotyping with multiple -omics data.

NCT ID: NCT05991661 Not yet recruiting - Asthma Clinical Trials

XKH001 Injection in Healthy Subjects

Start date: December 1, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a randomized, double-blind, placebo-controlled, multiple ascending dose (MAD) clinical study. The primary objective is to evaluate the safety, tolerability, and PK of multiple SC doses of XKH001 in healthy subjects.

NCT ID: NCT05991115 Not yet recruiting - Asthma Clinical Trials

Hospital to Home Study: Trial to Optimize Transitions and Address Disparities in Asthma Care

Start date: January 2024
Phase: N/A
Study type: Interventional

Caregiver-child dyads will be recruited during child's hospital admission for asthma exacerbation. Recruitment sites will be mainly Children's National Hospital Sheikh Zayed campus, as well as regional partners: Holy Cross Hospital, and Mary Washington Hospital. After enrollment, baseline data will be collected from caregiver. Caregiver-child dyads will be randomized (1:1 ratio) into the control arm or intervention arm. Control arm will receive the standard of care after hospital discharge. Intervention arm will receive the SOC plus an asthma navigator support after hospital discharge. Caregivers in both arms will complete data collection surveys (either in-person or via telehealth) at 3-,6-, 9-, and 12- month post enrollment.

NCT ID: NCT05989698 Recruiting - Asthma Clinical Trials

C-mo System 1.0's Validation - Cough Monitoring

C-mo_01
Start date: December 11, 2023
Phase: N/A
Study type: Interventional

Cough is one of the most reported symptoms, especially associated with respiratory diseases. Additionally, cough contains extremely insightful information regarding the patient's health. It is a symptom full of physiopathological information, which can be extremely helpful in clinical practice. However, cough is not currently used as a clinical biomarker given that: 1. Cough is an extremely subjective symptom for patients (patients can't accurately describe and understand their cough's traits). 2. There is currently no tool available to evaluate cough objectively and thoroughly. As such, there is an unmet medical need: solutions for objective cough monitoring and management. C-mo System is a novel non-invasive medical device, which performs an objective monitoring of the patient's cough for long periods of time. The C-mo System consists of a wearable device (C-mo wearable) and a desktop software (C-mo Medical Platform). C-mo System characterises cough automatically through data collection and processing techniques (automatic classification), and its base outputs include: - Cough frequency (how many times the patient coughs) - Cough intensity (how strong cough's expiratory effort is) - Cough type (if the cough is dry, wet, or laryngeal) - Identification of patterns (associations between cough characteristics and specific events, namely the time of day, body position, physical exercising, and meals). It is extremely important to validate C-mo System in a wide and diverse population, given the use of signal processing algorithms and artificial intelligence. C-mo System's base outputs will allow healthcare professionals to improve significantly the medical care associated with this symptom, namely: - Speed-up and improve the accuracy of the diagnosis of several medical conditions, especially respiratory diseases. C-mo System's ability to objectively monitor cough will allow healthcare professionals to make associations between specific cough patterns and specific medical conditions. - Optimize treatment prescription and monitor their effectiveness. C-mo System's objective assessment of cough will allow healthcare professionals to understand if a given therapy is working as intended. - Objectively monitor chronic disease progression. C-mo System's monitoring of cough will allow healthcare professionals to objectively assess the progression of the patient's cough.

NCT ID: NCT05985694 Recruiting - Eosinophilic Asthma Clinical Trials

AD17002 Treating Poorly Controlled, Moderate to Severe Eosinophilic Asthma

Start date: November 27, 2023
Phase: Phase 2
Study type: Interventional

This clinical trial aims to investigate patients with poorly controlled, moderate to severe eosinophilic asthma. The main questions it aims to answer are 1. Could the LTh(αK) intranasal treatment improve the clinical condition of these patients? 2. Could patients self-administrate LTh(αK) via the intranasal route? 3. Is the LTh(αK) at multiple doses safe for asthmatic patients? 4. Participants will be asked to self-administrate two doses per week for a total of 6 weeks (11 doses). A diary on LTh(αK) usage, adverse events, and reliever medication will be recorded.