Tracking CF Lung Disease Through the Early Years: Utility of the LCI

Completed

• Conditions: Observational
• Interventions: Other: This is an observational study, no intervention used.

• Registration Number: NCT03138772
• Lead Sponsor: Felix Ratjen

Brief Summary

This is a prospective observational study to follow a cohort of patients with Cystic Fibrosis and healthy controls for a period of two years. This study will include monitoring the subjects lung clearance index (by performing a breathing test called the multiple breath washout), as well as spirometry and their respiratory symptoms every three months as well as during a pulmonary exacerbation and after their recovery.

Detailed Description

This is a prospective observational cohort study. During the 3 year study period, each participant will be followed for a period of 2 years. The study will include quarterly measurements of the lung clearance index (LCI), as well as spirometry, for CF patients at their routine clinic visits. Parents of patients with CF will be asked to call the study nurse or clinical nurse if they experience a worsening of pulmonary symptoms and to come to the clinic for assessment of lung function. CF patients will then be assessed by a CF physician to assess whether they require antibiotic treatment based on a clinicians decisions to treat with antibiotics. The treatment decision will be left to the discretion of the patient's responsible physician, who will be blinded to the MBW results. All patients who meet the symptom based definition of a pulmonary exacerbation, regardless of treatment decision, will have MBW measured after 4 weeks. Following these visits at the time of an exacerbation, patients will have their MBW measured at their next clinic visit (usually within 3 months), and every 3 months thereafter until the end of the 2 year observation period, or the repeat onset of symptoms.This study will capture a maximum of two exacerbations per patient over the 2 year study period.

Study Timeline

• Study First Submitted: 2017-04-27
• Study First Submitted QC: 2017-05-01
• Study First Posted: 2017-05-03
• Study Start: 2017-10-05
• Primary Completion: 2020-10-01
• Status Verified: 2021-09
• Study Completion: 2021-09-01
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

Not provided

Exclusion Criteria

• Previous organ transplantation
• Chronic lung disease not related to CF, such as asthma
• Use of intravenous antibiotics or other course of oral antibiotics (excluding maintenance treatment antibiotics) within 14 days of enrollment visit
• Physical findings at screening that would compromise the safety of the participant or the quality of the study data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Controls	This is an observational study, no intervention used.	No intervention. Only monitoring LCI
Cystic Fibrosis Patients	This is an observational study, no intervention used.	No intervention. Only monitoring LCI

Primary Outcome Measures

Name	Time	Method
Lung Clearance Index	an average of 2 years	Outcome measure from the Multiple Breath Washout test.

Secondary Outcome Measures

Name	Time	Method
Respiratory Cultures	an average of 2 years	Bacterial pathogens IL-8 and neutrophil elastase
Spirometry	an average of 2 years	FEV1
Respiratory Symptoms	an average of 2 years	CFRSD-CRISS

Trial Locations

Locations (1)

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada