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

NCT03138772 | Completed

• 1 other identifier: 1000055762
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Observational

Outcome Measures

Primary Outcomes (1)

• Lung Clearance Index

  Outcome measure from the Multiple Breath Washout test.

  an average of 2 years

Secondary Outcomes (4)

• Spirometry

  an average of 2 years

• Respiratory Cultures

  an average of 2 years

• Respiratory Symptoms

  an average of 2 years

• Respiratory Symptoms

  an average of 2 years

Study Arms (2)

Healthy Controls

No intervention. Only monitoring LCI

Other: This is an observational study, no intervention used.

Cystic Fibrosis Patients

No intervention. Only monitoring LCI

Other: This is an observational study, no intervention used.

Interventions

This is an observational study, no intervention used. OTHER

No intervention is being used in this study.

Cystic Fibrosis Patients; Healthy Controls

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

There were 139 subjects recruited in the original preschool longitudinal study, and all participants from this original study will be invited to participate in this follow up study. We would like to recruit an additional 40 CF patients at the Hospital for Sick Children to increase our cohort size.

You may qualify if:

• Informed consent by patient or parent/legal guardian, verbal assent where appropriate
• Age 3 years to 16 years old
• Clinically stable with no signs of an acute exacerbation at enrollment visit
• Previously participated in a longitudinal MBW study at the Hospital for Sick Children and at the Riley Hospital for Children
• Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride \> 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations
• Informed consent by patient or parent/legal guardian, verbal assent where appropriate
• Age 3 years to 16 years old
• Clinically stable with no signs of an acute exacerbation at enrollment visit

You may not qualify if:

• 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

Sponsors & Collaborators

• Felix Ratjen: lead

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Study Officials

• Felix Ratjen, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 3, 2017
• Study Start: October 5, 2017
• Primary Completion: October 1, 2020
• Study Completion: September 1, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)