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Wheezing clinical trials

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NCT ID: NCT05682664 Not yet recruiting - Telemedicine Clinical Trials

Luchtbrug Junior: the Next Step

Start date: August 1, 2024
Phase: N/A
Study type: Interventional

Rationale: The introduction of e-health in the monitoring and management of patients with chronic conditions can be beneficial and efficient. The introduction of an online monitoring and management tool, "Luchtbrug", for children 6-16 yrs of age with asthma while reducing 50% of visits to the outpatient clinic, results in similar or improved asthma control while reducing costs. It is highly likely that this concept of e-health is suitable for other chronic conditions. Therefore the aim of the study is to investigate the added value of online monitoring and management of children with preschool wheeze (2-6 yrs of age). Objective: To assess whether the number of symptom free days can be improved using online monitoring and disease management via Luchtbrug Junior, while reducing the number of outpatient clinic visits by 50% Study design: Prospective multicentre (n=6) randomised trial in which disease management via Luchtbrug Junior will be compared with usual care. Follow-up: 12 months. Study population: children aged 2-6 yrs with preschool wheezing (multiple episode of cough, wheeze and dyspnoea). Intervention (if applicable): Children will be randomised into usual care (n=135) or partly online care via Luchtbrug Junior (n = 135) Main study parameters/endpoints: Primary objective: Number of symptom free days (SFDs) based on the TRACK questionnaire, during the last four weeks of the study (measured at 12 months). Secondary objectives: Healthcare consumption: unscheduled visits Emergency Department (ED) or outpatient clinic, unscheduled phone calls, hospital admissions) Questionnaires into: Quality of Life (QoL), cost-effectiveness (direct and indirect costs), self-management of patients, adherence to treatment, satisfaction of parents/caregivers. Usual care consists of regular visits to the outpatient clinic every 3 months after starting the study. In between visits contact with the healthcare team is by telephone as needed. At 3, 6, 9 and 12 months, patients will be asked to complete the TRACK questionnaire. Online care using Luchtbrug Junior will include visits to the outpatient clinic every 6 months after starting the study. In between visits, parents/caregivers of the patient will be asked to answer the digital version of TRACK questionnaire monthly, therefore the parents/caregivers will received email-reminders. Appropriate feedback on their TRACK-scores will be provided by their healthcare team within two working days. Any interventions such as adjustment of treatment are at the judgment of the treating pediatrician. Therapy adherence will be monitored during the study by using smart inhalers.

NCT ID: NCT05667701 Recruiting - Asthma in Children Clinical Trials

Soy Isoflavones For Inner City Infants At Risk For Asthma (SIRA) Study

SIRA
Start date: March 15, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to compare soy isoflavones to placebo in children who at risk of asthma and have a genetic variation which results in them making more of a pro-inflammatory protein, plasminogen activator inhibitor-1. The main questions this trail seeks to answer is: will soy isoflavones decrease wheezing episodes in these children when given in the first year of life. Participants will be asked to ingest soy isoflavone or placebo twice daily mixed into a liquid or puree vehicle for 7 months from randomization. There will be 3 mandatory in-person visits, and 6 virtual visits in the first year. There will also be 11 monthly questionnaires and 1 in person visit in the observation year. Participants will have 4 nasal swabs, 3 blood draws, and also provide 4 stool samples over the course of the study.

NCT ID: NCT05447832 Not yet recruiting - Wheezing Clinical Trials

Remote Monitoring in Preschool Wheeze

Start date: August 2022
Phase:
Study type: Observational

The aim of this project is to fill the significant unmet healthcare need to prevent wheeze attacks in preschool children. This will be achieved by developing a proof-of-concept, bespoke home remote objective monitoring system for preschool children that can identify early signs before a wheeze attack to allow early intervention and prevention. This study aims to develop methods for recognising child-specific abnormal patterns in time-course lung function data, and wheeze onset providing early warning of deterioration. The prototype system is targeted for use by caregivers of preschool children with wheeze, and will integrate the individual child's information about symptoms, medication use and lung function to alert parents to seek healthcare advice to prevent hospitalisation.

NCT ID: NCT05304494 Withdrawn - Asthma Clinical Trials

Sentinel - Triaging Acute Breathlessness Using Multi-Modal Biomarkers

Start date: March 2022
Phase:
Study type: Observational

The Sentinel-001 study aims to identify a combination of biomarkers suitable for triage of breathlessness.

NCT ID: NCT05210361 Active, not recruiting - Asthma in Children Clinical Trials

Critical Windows in the Development of Asthma Endotypes and Phenotypes in High-Risk Toddlers

WINDOWS
Start date: February 14, 2022
Phase:
Study type: Observational

The purpose of this study is to learn more about how asthma develops in early childhood. This will help doctors understand how to prevent and treat asthma better.

NCT ID: NCT05064631 Recruiting - Clinical trials for Respiratory Tract Infections

Bacterial Lysate In Preventing Asthma

BLIPA
Start date: January 12, 2022
Phase: Phase 2
Study type: Interventional

Bronchiolitis is a common viral infection of the small airways of infants and some affected infants will require hospital admission. Severe bronchiolitis is a marker for greatly increased risk of developing both preschool wheeze and subsequent school age asthma. Since epidemiological studies suggest that exposure to microbial products protects against preschool wheeze, lysates of bacteria may prevent the development of wheeze after bronchiolitis, with long-term beneficial consequences. BLIPA is a phase 2b, randomised, double blind, placebo-controlled study, investigating the efficacy superiority of bacterial lysate (Broncho Vaxom) capsules over placebo, in reducing wheeze in infants after severe bronchiolitis. The primary end point of the study is parent-reported, healthcare-professional confirmed wheeze at 19-24 months. The study aims to test bacterial lysate capsules (3.5mg over 24 months) for safety, efficacy, and to advance mechanistic understanding of its action.

NCT ID: NCT05063149 Recruiting - Premature Clinical Trials

Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.

PROTEA
Start date: January 18, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first year of life by bacterial lysate administration. Next to determine the correlation of biological markers with respiratory symptoms, immune protection and treatment effect.

NCT ID: NCT04942483 Active, not recruiting - Wheezing Clinical Trials

Using Specific Tests in Preschool Children With Wheeze to Help us Determine the Necessity of Inhaled Corticosteroid Therapy (Feasibility Study).

TAILOR
Start date: November 17, 2021
Phase:
Study type: Observational

Wheezing is common in preschool children and affects quality of life. Although asthma treatments such as inhaled steroids (ICS), which reduce swelling (inflammation) in the airways are used in this age group, they are often ineffective. That is because only some preschool children have the type of inflammation (known as Type 2 inflammation) that responds to ICS, thus many children are being unnecessarily exposed to side effects. It is difficult diagnosing Type 2 inflammation through history and examination, thus other indicators are needed to ensure ICS are only given to children who will benefit. These indicators are commonly known as biomarkers, and we are trying to find out if they are useful. We want to measure three biomarkers, without changing children's treatment. The first is blood eosinophils. which can be measured using a finger prick sample (like the blood drop used for measuring sugar levels in diabetic children). The second is to determine if allergic sensitization is present to allergens that are breathed in; these will be house dust mite, grass pollen, tree pollen, cat and dog hair. The final biomarker is a molecule that is produced in the airways of preschool children with Type 2 inflammation, called nitric oxide (NO). This is easily obtained, by having children breathe through a mask and collecting their breath in a bag, measuring NO later on. The children will be followed up with monthly electronic questionnaires and 3-monthly visits (virtual or face-to-face) for a year to evaluate whether these markers individually or in combination relate to subsequent wheezing outcomes, and how acceptable the measurements are to families using a questionnaire and focus group approach. The results will form the basis of the design of a national trial of biomarker-driven therapy in such children.

NCT ID: NCT04811248 Recruiting - Asthma in Children Clinical Trials

Respiratory Outcome of Infants With or Without Documented Wheezing During Bronchiolitis

WheezOut
Start date: January 8, 2021
Phase:
Study type: Observational

Hospital admission for infant bronchiolitis is associated with an increased risk of recurrent wheezing and subsequent asthma in childhood. In the literature, 17 to 60% of children will develop repeated wheezing (infant asthma in France). This highly variable incidence could be linked in part to the fact that the definition of bronchiolitis varies between continents. In Europe the usual definition is an acute and contagious viral infection which affects the bronchioles (small bronchi) of infants accompanied by coughing, rapid breathing and wheezing. In research studies, bronchiolitis must be associated with wheezing and / or crackles on auscultation in Europe, and wheezing imperatively in the USA. The diagnosis of wheezing is difficult, and medical agreement on auscultatory respiratory abnormalities is poor. We thus have developed a wheezing diagnostic tool using artificial intelligence processing of respiratory sound recordings by smartphone (Bokov P, Comput Biol Med 2016, DOI: 10.1016/j.compbiomed.2016.01.002). In a second larger bicentric study that included only infants suspected of bronchiolitis, our approach has consisted in obtaining a recording by smartphone but also by electronic stethoscope in order to allow deferred listening of the sounds (WheezSmart study). The objective of these studies was to obtain a formal diagnosis of wheezing, the current project aims to assess the benefit of this diagnosis. The main objective of this cross-sectional study is to determine whether the formal presence (diagnosis of wheezing from a recording of pulmonary auscultation) is associated with the risk of childhood asthma (diagnosis of asthma at 6 years) regardless of the usual risk factors (atopic / allergic terrain, exposure to smoking, recurrence of symptoms). The secondary objectives are to determine whether the formal presence of wheezing on auscultation is a risk factor for subsequent repeated wheezing (diagnosis of infant asthma) and for initial disease severity (bronchiolitis) compared to SpO2 and admission of the child to hospital. The interest in differentiating between high and low frequency sibilants will be evaluated also.

NCT ID: NCT04689412 Completed - Wheezing Clinical Trials

Nasal Resveratrol and Wheezing Episodes in Preschool Children

RSVchild
Start date: April 1, 2018
Phase:
Study type: Observational

As most of the upper airways infections (UAI) leading to wheezing are secondary to viral triggers, the possible antinflammatory and antiviral role of resveratrol has been suggested in several studies, both in vitro and in vivo. However, its efficacy has been studied only when evaluating upper respiratory symptoms. With the aim to define new approaches in patients with recurrent wheezing triggered by UAI we have performed a prospective observational study to evaluate the efficacy of a short-course of intranasal resveratrol, administered for 7 days at the beginning of UAI, when compared to standard nasal lavage with 0.9% saline solution, in terms of reduction in wheezing episodes.