Air Pollution and Children With Cystic Fibrosis

NCT03853629 | Completed

• 1 other identifier: 215879
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To determine personal exposure to air pollution in children with cystic fibrosis;
2. 2.To determine airway macrophage uptake of inhaled particulate matter in cystic fibrosis children;
3. 3.To establish whether prostaglandin E2 affects particulate matter removal in airway.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Airway macrophage uptake of inhaled particulate matter in both groups of children

  Black carbon loading area (micro-square meters) of airway macrophages, using light microscopy

  3 years

Secondary Outcomes (1)

• Personal exposure to air pollution in both groups of children

  3 years

Study Arms (2)

CF

* Age 1-17 * Diagnosis of Cystic Fibrosis * Living in or around London

Other: None. Not applicable

Controls

* Age 1-17 * Healthy * Living in or around London

Other: None. Not applicable

Interventions

None. Not applicable OTHER

None. Not applicable

CF; Controls

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Inclusion Criteria: * Age 1-17 * Diagnosis of Cystic Fibrosis * Diagnosis of non-CF bronchiectasis * Living in or around London With age matched healthy controls Exclusion Criteria: * Current active smoker * Receiving immunosuppressive drug therapy * For children with CF not on regular nebulised hypertonic saline: drop in FEV1 of \>15% post-bronchodilator (exclusion criterion for sputum induction) * For healthy controls: Post-bronchodilator FEV1 \<80% (standard exclusion criterion for sputum induction in healthy individuals) * For participants currently or recently involved in other research study, they will be excluded if their current or recent research have any potential impact on our sampling or results.

You may qualify if:

• Age 1-17
• Diagnosis of Cystic Fibrosis
• Diagnosis of non-CF bronchiectasis
• Living in or around London With age matched healthy controls

You may not qualify if:

• Current active smoker
• Receiving immunosuppressive drug therapy
• For participants currently or recently involved in other research study, they will be excluded if their current or recent research have any potential impact on our sampling or results.

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Queen Mary University of London

London, E1 2AT, United Kingdom

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Jonathan Grigg

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 25, 2019
• Study Start: February 15, 2017
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: March 10, 2020

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)