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Clinical and psychosocial changes over late childhood and adolescence and early life determinants of long term clinical outcomes in cystic fibrosis Study

Clinical and psychosocial changes over late childhood and adolescence and early life determinants of long term clinical outcomes in cystic fibrosis Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12613000778785
Acronym
Follow-up ACFBAL Study (FAB) Study
Enrollment
118
Registered
2013-07-11
Start date
2014-08-01
Completion date
2019-05-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose of the study is to further improve outcomes in CF by developing a better understanding of the reasons for the decline in health status and lung function during adolescence, which is one of the key challenges facing clinicians. We hope to do this by looking at such things as the 1) pathology involved in CF lung disease, 2) long term risks of emerging organisms, 3)potential effects of early therapeutic interventions, such as P. aeruginosa eradication, 4) metagenomic profile identifying bacteria in respiratory samples, 5) psychosocial factors, and 6) relationship between early life events and outcomes between 9 - 17 years of age.

Interventions

Two study visits will occur from 12 months up to 3 years depending on the timing of the initial visit. At each visit clinical data will be recorded including: current symptoms, physical examination, weight, height, concomitant medications, spirometry, induced sputum collection and urine for matrix breakdown products and biomarkers of neutrophilic inflammation. Blood is collected routinely for review tests and will be collected and stored for inflammatory mediators. Health Related Quality of Life

Two study visits will occur from 12 months up to 3 years depending on the timing of the initial visit. At each visit clinical data will be recorded including: current symptoms, physical examination, weight, height, concomitant medications, spirometry, induced sputum collection and urine for matrix breakdown products and biomarkers of neutrophilic inflammation. Blood is collected routinely for review tests and will be collected and stored for inflammatory mediators. Health Related Quality of Life questionnaires and other standard measures of psychosocial health are completed and a bone density test (a DEXA), and a low dose chest CT scan will be done at the start and end of the study (again this is depending on the timing of the initial visit).

Sponsors

The University of Queensland
Lead SponsorUniversity

Eligibility

Sex/Gender
All
Age
9 Years to 15 Years
Healthy volunteers
No

Inclusion criteria

All children with cystic fibrosis who completed the ACFBAL Study (ACTRN12605000665639) CE Wainwright et al. Effect of Bronchoalveolar lavage-Directed Therapy on Pseudomonas aeruginosa Infection and Structural Lung Injury in Children with Cystic Fibrosis A Randomized Trial. JAMA 13 July 2011; 306(2): 163-171.

Exclusion criteria

Children who did not not complete the ACFBAL study

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026