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

Not Applicable

Completed

• Conditions: cystic fibrosis; Respiratory - Other respiratory disorders / diseases; Human Genetics and Inherited Disorders - Cystic fibrosis

• Registration Number: ACTRN12613000778785
• Lead Sponsor: The University of Queensland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-07-11
• Study Completion: 2019-06-30
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Repeated measures of the FEV1 best annual values as SD-scores (z-scores) over the study duration using a calibrated spirometer. These data will have been collected at each clinic visit attended by the patient. [3 years];CT scan scores. A low dose spirometer-controlled inspiratory and expiratory volumetric chest CT scans using a standard protocol will be performed without contrast at the start of the study and in the final year. [3 years];Association between the measures of Quality of Life and psychosocial functioning. The tests used are CFQ-R for parents and children and LSAC, . Parent social demographics, functioning and mental health (Brief COPE) will be done along with the Family Stress Scale. This is a composite primary outcome.[3 years]

Secondary Outcome Measures

Name	Time	Method
il[N/A]