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Wheezing clinical trials

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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: 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: NCT04669288 Recruiting - Asthma Clinical Trials

AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department

AZ-SWED
Start date: September 22, 2021
Phase: Phase 3
Study type: Interventional

AZ-SWED is a parallel group, double blind, placebo control efficacy clinical trial with two separate hypotheses. The trial will compare the 5-day outcome of preschool children presenting to an Emergency Department (ED) with an acute, severe wheezing episode and treated with either once daily oral Azithromycin (12 mg/kg/day for 5 days) or placebo. The AZ-SWED researchers will make separate comparisons in children in whom specific pathogenic bacteria are isolated from nasopharyngeal swabs, and in those in whom they are not isolated. The primary outcome will be the Asthma Flare-up Diary for Young Children (ADYC), a validated instrument that caregivers will transmit electronically daily after discharge from the ED. Families will be contacted daily during the five-day treatment to collect the ADYC, and to assess compliance and complications. A randomly chosen subset of enrolled children will participate in two follow-up visits 5-8 days and 14-21 days after visit 1 to assess development of resistance to study drug and treatment response related changes in the airway microbiome.

NCT ID: NCT04128592 Recruiting - Wheezing Clinical Trials

Non-invasive Differential Diagnosis of Noisy Breathing Infants and Toddlers

NiNbI
Start date: October 30, 2018
Phase: N/A
Study type: Interventional

Almost 50% of all children have at least 1 episode of noisy breathing before the age of 2 years and almost 25% of these children have more episodes of noisy breathing. The lack of an objective technique for diagnosing noisy breathing children often leads to overrated diagnosis of "wheezing", whereas there may be other noisy breathing phenotypes, like "rattling", that don't favor from the same therapeutic treatment. Presumably, different underlying pathophysiological mechanisms are involved with different biomarker profiles characteristic for different phenotypes. The goal of this study is to optimize the diagnosis of noisy breathing infants and toddlers. Children will be followed for a treatment period of 6 weeks and will visit the paediatrician 3 times (week 0, 3 and 6). During the consultations breath sound analysis will be performed and a breath sample and a nasal mucus will be collected to analyse biomarker profiles. Both methods for diagnosing noisy breathing infants are non-invasive and will be compared to the standard procedure of the paediatrician which consists of auscultation and palpation of the chest. An objective and non-invasive method for diagnosing noisy breathing infants and toddler will pave the way for more cost-effective and personalized prescription of therapies which will increase the quality of life of children with noisy breathing.

NCT ID: NCT04063631 Recruiting - Asthma Clinical Trials

Pulmonary Epithelium, Immunology and Development of Asthma: Breathing Together

Start date: February 20, 2017
Phase:
Study type: Observational

The investigators want to know why some babies wheeze and some of these go on to develop asthma. The investigators are going to find out if babies who develop wheeze and asthma have abnormal airway lining cells (taken from the nose) when they are born and what happens to these cells as they get older. The study will last three years. Parents will be asked to fill in a monthly health questionnaire. The tests on the babies are all in routine clinical use: a urine sample, a blood test from a heel or finger prick, swabs from the nose and throat to look at the microbiome, and a brushing of cells from the inside of the nose. These tests will be performed at 5-10 days old, and at one and three years. Parents will be asked to fill in online monthly health questionnaire. Some babies will have the swabs repeated at 3 and 6 months, and those who wheeze in the first 3 years of life, samples during the illness and after recovery.

NCT ID: NCT03505216 Recruiting - Asthma Clinical Trials

Swiss Paediatric Airway Cohort

SPAC
Start date: June 6, 2017
Phase:
Study type: Observational

The Swiss Paediatric Airway Cohort (SPAC) is a national, prospective clinical cohort of children and adolescents who visit physicians in Switzerland for recurrent wheeze, cough, and exercise- or sleep-related respiratory problems. SPAC aims to answer important questions on clinical phenotypes, prognosis, diagnosis and treatment. SPAC is part of routine care, and only clinically indicated investigations are done. The comprehensive baseline assessment includes a detailed questionnaire to families, plus test results, diagnoses and treatments from hospital records. Follow-up is via monthly questionnaires the first 12 months and thereafter annual questionnaires to families, and data from follow-up visits. Currently, 4344 patients from 10 clinics and hospitals in Switzerland (Aarau, Basel, Bern, Chur, Horgen, Lausanne, Luzern, St. Gallen, Worb, Zurich) have been enrolled. SPAC provides real-life data on children visiting the Swiss health care system for common respiratory problems. It will provide a research platform for health services research, and for nested clinical and transitional studies. Publications and plain language summaries are listed on the study website: https://www.spac-study.ch/publikationen/

NCT ID: NCT03206710 Recruiting - Asthma Clinical Trials

Vitamin C Supplementation to Pregnant Smokers: Follow-up of 2 Randomized Trials Plus Changes in DNA Methylation

VCSIP-ECHO
Start date: June 1, 2017
Phase:
Study type: Observational

In a randomized clinical trial (RCT) published in JAMA, the investigators have provided evidence that vitamin C supplementation (500 mg daily during pregnancy) ameliorates the effects of maternal smoking during pregnancy on offspring lung function and subsequent incidence of wheeze by 48% through 1 year of age. The investigators are currently completing a second RCT of vitamin C supplementation in pregnant smokers with more robust measures of pulmonary outcomes. The purpose of this ECHO application is to combine these 2 focused, interventional cohorts to allow critical longitudinal follow-up of respiratory outcomes in these children including the study of pulmonary function test (PFT) trajectories and incidence of recurrent wheeze/asthma from infancy through early adolescence in offspring of pregnant smokers randomized to vitamin C versus placebo.

NCT ID: NCT03203603 Recruiting - Asthma Clinical Trials

VCSIP Follow-up Study

VCSIPRenewal
Start date: March 27, 2017
Phase:
Study type: Observational

The overall aims of this protocol are to determine whether prenatal supplementation with vitamin C to pregnant smokers can improve pulmonary function and decrease wheeze at 5 years of age in their offspring. This is a continuation of the VCSIP trial, to follow the offspring through 5 years of age. The hypothesis for this protocol is an extension of the VCSIP trial that supplemental vitamin C in pregnant smokers can significantly improve their children's PFTs and decrease the incidence of wheeze.

NCT ID: NCT02295007 Recruiting - Fever Clinical Trials

Fever and Wheezing Events in Children After US Influenza Vaccines Using Text Messaging

Start date: December 2014
Phase: N/A
Study type: Interventional

Children 2-11 years of age who are given the influenza vaccine (inactivated influenza (IIV) or live attenuated influenza vaccine (LAIV)) as part of their routine care can enroll in this study if their parent has the ability to receive and send text messages. Children enrolled in this study will be observed daily for an eight-day period starting on the day of vaccine administration, and then continuing over the next 7 days, and then weekly for 42 days. On the day of enrollment and nightly for the next seven days, the parent will report via text message what their child's highest temperature is. If fever is present, they will then be prompted for additional information including other symptoms, antipyretic use and medical care sought. On day 3 as well as weekly from day 7 through day 42 post-vaccination, parents will be asked via text message about breathing problems, specifically cough, wheezing and chest tightness. They will also be asked about medications taken and care sought. The purpose of this study is to assess the feasibility of collecting this data.