Pulmonary Epithelium, Immunology and Development of Asthma: Breathing Together

NCT04063631 | Unknown

• 1 other identifier: 16IC3652
• Study Type: observational
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma; Wheezing

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

• Changes on airway epithelium cells assessed by cell biology tools

  To detect the airway epithelium cells differences between onset of wheeze, wheezers and non-wheezers with swabs from the nose

  3 years

Study Arms (4)

1/Birth cohort

Prospective, longitudinal cohort of 1000 healthy infants. Recruited at birth and followed for 3 years. Samples to be collected at 5-10 days old, 1 and 3 years old. 100 participants with additional samples collected at 3 and 6 months of age. Approximately 300 participants to have samples collected at time of active wheezing and during convalescence.

2/mild wheezers and controls

Children under 5 years old undergoing elective general surgical procedure. Some will have mild-to-moderate wheeze while others will be non-wheezing controls

3/pre-school aged severe wheezers

50 children aged 1-6 years undergoing clinically indicated bronchoscopy due to recurrent wheezing.

4/school aged severe asthmatics

50 kids aged 6-16 undergoing clinically indicated bronchoscopy due to asthma.

Eligibility Criteria

• Age: 5 Days - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Singleton neonates with the developing wheeze in the before their third birthday and young children (≤5 years) with a history of mild to moderate wheezing, and those without previous wheezing.

You may qualify if:

• expectant mother or infant aged 0-10 days
• children with recurrent wheezing and other clinical atopy
• children with recurrent wheezing and no obvious wheezing triggered by aeroallergens and no clinical evidence of other atopy.
• children with no history of wheezing but with at least one clinically apparent atopic disorder
• children with no history of wheezing and with no clinical evidence of other atopic disorder
• all children will be undergoing an elective surgical procedure
• all children will have been born at term (37-42 weeks gestation)
• the anaesthetist will have deemed the child fit for elective surgery, free from a recent respiratory tract infection, stable and suitable for the research study samples to be taken.
• in the case of blind non-bronchoscopic sample suitable for endotracheal intubation or for a fibre-optic bronchoscopy if this is the chosen method of sampling

You may not qualify if:

• pre-term infants (\<37 weeks gestation)
• twins or other multiples
• maternal group B streptococcus on high vaginal swab in the present pregnancy
• need for CPAP or ventilatory support in the neonatal period
• infants with major concurrent health problems, e.g. congenital heart disease, cystic fibrosis, those requiring special feeding regimens on account of prematurity or illness
• infants who will not be available to assess acutely if they develop wheeze
• infants who are likely to move away from the study centre before 3 years of age
• children with a recent respiratory tract illness (should have recovered \> 2 weeks)
• children with other major respiratory illnesses such as and including Cystic Fibrosis, Chronic Neonatal Lung Disease, pulmonary aspiration syndromes.
• children with evidence of a systemic inflammatory or infective condition
• children with a history of previous pituitary or ethmoid surgery

Sponsors & Collaborators

• Imperial College London: lead
• Queen Mary University of London: collaborator
• University of Bristol: collaborator
• University of Southampton: collaborator
• University of Edinburgh: collaborator
• Queen's University, Belfast: collaborator
• University of Aberdeen: collaborator
• Monash University: collaborator

Study Sites (1)

Royal Brompton and Harefield NHS Foundation Trust

London, SW£ 6NP, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Nasal and throat swabs, nasal epithelial cells, mRNA from nasal epithelial cells, mRNA from blood, blood

MeSH Terms

Conditions

Asthma; Respiratory Sounds

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Bush, MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mindy L Gore, PhD

CONTACT

+442075946857; m.gore@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2019
• First Posted: August 21, 2019
• Study Start: February 20, 2017
• Primary Completion: September 18, 2024
• Study Completion: September 18, 2024
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)