Safety of bronchoalveolar lavage in young children with cystic fibrosis

Wainwright, Claire; Grimwood, Keith; Carlin, John B.; Vidmar, Suzanna; Cooper, Peter; Francis, P.; Byrnes, Catherine A; Whitehead, Bruce; Martin, Andrew; Robertson, Ian F.; Cooper, David M.; Dakin, Carolyn; Masters, Ian Brent; Massie, John; Robinson, Philip; Ranganathan, Sarath; Armstrong, David; Patterson, L.; Robertson, Colin F.

doi:10.1002/ppul.20885

Cited by 49 publications

(22 citation statements)

References 28 publications

(51 reference statements)

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“…(64) Bronchoscopic evaluation has shown heterogeneity of distal airway drug deposition among children of different ages. Although generally safe, (65) flexible bronchoscopy does require anesthesia in young children and, thus, results in healthy controls may be unobtainable due to restrictions from institutional review boards. Notable limitations of using bronchoscopy to study aerosol deposition include the fact that BAL fluid samples are typically obtained from one or two lobes and, thus, present with an inherent sampling error.…”

Section: Flexible Bronchoscopymentioning

confidence: 98%

Challenges and Limitations of Testing Efficacy of Aerosol Device Delivery in Young Children

Goralski

Davis

2014

Journal of Aerosol Medicine and Pulmonary Drug Delivery

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An increasing number of medical conditions are chronically or acutely managed with some form of aerosolized therapy. Due to the benefit of directly administering medications to the intended site of action, there is great interest in evaluating treatments for aerosol use. One of the major challenges in selecting and testing new drug-device combinations in children is the uncertainty regarding the appropriate outcome measure to choose. In studies involving adult patients, typically exacerbations of disease or airflow obstruction are assessed as endpoints in drug trials or device assessment. However, in young children, choosing endpoints to assess efficacy is difficult due to the potential lack of sensitive, noninvasive endpoints that are easily performed across sites. In this review, we discuss the challenges and limitations of selecting clinical endpoints for drug-device trials in the youngest population, with a focus on novel emerging technologies. This article provides an overview of preschool and infant pulmonary function testing, multiple-breath washout, imaging techniques including computed tomography and magnetic resonance imaging, flexible bronchoscopy in children, mucociliary clearance scans, and exhaled breath condensate.

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Section: Flexible Bronchoscopymentioning

confidence: 98%

Challenges and Limitations of Testing Efficacy of Aerosol Device Delivery in Young Children

Goralski

Davis

2014

Journal of Aerosol Medicine and Pulmonary Drug Delivery

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“…Patients are reviewed every 2 to 3 months with sputum or cough swab specimens each visit. Patients under 6 years were enrolled in a randomised controlled trial of broncho-alveolar lavage (BAL) guided therapy (1999)(2000)(2001)(2002)(2003)(2004)(2005) [12,13] or the AREST CF programme (www.ARESTCF. com.au) which included broncho-alveolar lavage (BAL) soon after diagnosis and annually.…”

Section: Settingmentioning

confidence: 99%

Australian epidemic strain pseudomonas (AES-1) declines further in a cohort segregated cystic fibrosis clinic

Griffiths

Wurzel

Robinson

et al. 2012

Journal of Cystic Fibrosis

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“…Eight studies out of those included in this review were found to describe short-term (hours or days) adverse events related to BAL procedures [6,8,22,50,52,54,64,65] (table E6). Reported adverse events were mainly mild, for example mild fever, worsening of cough, mild respiratory distress or stridor.…”

Section: Feasibility and Safetymentioning

confidence: 99%

“…Of note, BAL has been extensively studied in children (.333 procedures in 107 infants in one study [65]), but not adults, in particular in the presence of very altered lung function (FEV1 ,40%) [13,22,26,52,65]. In this latter subgroup of patients, the volume recovered may be decreased and the risk of the procedure increased.…”

Section: Group Consensus On Feasibilitymentioning

confidence: 99%

Clinimetric properties of bronchoalveolar lavage inflammatory markers in cystic fibrosis

Fayon

Kent

Bui

et al. 2013

European Respiratory Journal

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The Standardisation Committee of the European Cystic Fibrosis Society Clinical TrialNetwork has undertaken the evaluation of clinical end-points for therapeutic interventions regarding their use in multicentre clinical trials in cystic fibrosis (CF). This review of biomarkers in bronchoalveolar lavage (BAL) is part of the group's work.The aims of this project were: 1) to review the literature on reliability, validity and responsiveness of BAL in patients with CF; 2) to gain consensus of the group on the feasibility of BAL; and 3) to gain consensus on answers to key questions regarding the promotion of BAL to surrogate end-point status.Assessment of BAL inflammatory markers in the literature indicates that their reliability, validity and responsiveness are adequate for clinical trials. After discussion of the practical characteristics it was concluded that BAL has an attractive validity profile, albeit with limited feasibility. It is particularly applicable to multicentre trials in preschool children with CF and early or mild lung disease. This is the first article to collate the literature in this manner. This provides a rationale to support the use of BAL in early clinical trials in preschool children with CF. @ERSpublications Review of the literature provides rationale to support the use of BAL in well-designed early-phase clinical trials in CF

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Safety of bronchoalveolar lavage in young children with cystic fibrosis

Abstract: Adverse events are common with BAL in young CF children, but are usually transient and well tolerated. Parents should be counseled that signs of a pre-existing lower respiratory infection are associated with increased risk of post-BAL fever.

Cited by 49 publications

References 28 publications

Challenges and Limitations of Testing Efficacy of Aerosol Device Delivery in Young Children

Challenges and Limitations of Testing Efficacy of Aerosol Device Delivery in Young Children

Australian epidemic strain pseudomonas (AES-1) declines further in a cohort segregated cystic fibrosis clinic

Clinimetric properties of bronchoalveolar lavage inflammatory markers in cystic fibrosis

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