Original articleHigh-Dose Ibuprofen in Cystic Fibrosis: Canadian Safety and Effectiveness Trial
Section snippets
Methods
This was a multicenter, double-blinded, placebo-controlled trial.
Results
A total of 142 patients (70 in the ibuprofen group and 72 in the placebo group) were enrolled in the trial (Figure 1). Recruitment was stopped at that point, because a survey of participating centers revealed that prolonging the recruitment period would produce no significant increase in enrollments. The groups had similar baseline characteristics (Table I). At study enrollment, the patients had mild lung disease (mean FEV1 >90%) and were reasonably well nourished, with mean z scores for height
Discussion
We found that high-dose ibuprofen significantly slowed the decline in FVC in a group of children and adolescents with CF who initially had well-preserved lung function. The ibuprofen group had fewer days spent in the hospital. Ibuprofen generally was well tolerated, with only 4 subjects withdrawing due to adverse events.
Our findings are consistent with those of Konstan et al,6 who found that children with mild lung disease benefited the most from this therapeutic strategy. Compared with their
References (17)
- et al.
Cystic fibrosis birth rates in Canada: a decreasing trend since the onset of genetic testing
J Pediatr
(2005) - et al.
A multicenter study of alternate-day prednisone therapy in patients with cystic fibrosis
J Pediatr
(1995) - et al.
Long-term azithromycin in children with cystic fibrosis: a randomised, placebo-controlled crossover trial
Lancet
(2002) - et al.
The use of anti-inflammatory medications in cystic fibrosis: trends and physician attitudes
Chest
(1999) - et al.
Nutritional assessment and management in cystic fibrosis: a consensus report
Am J Clin Nutr
(1992) - et al.
Use of high-dose ibuprofen in a pediatric cystic fibrosis center
J Cystic Fibrosis
(2007) - et al.
Identifying treatments that halt progression of pulmonary disease in cystic fibrosis
Pediatr Res
(1997) A controlled trial of long-term inhaled hypertonic saline in patients with cystic fibrosis
N Engl J Med
(2006)
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2020, Journal of Cystic FibrosisCitation Excerpt :For this reason, targeting lung inflammation has long been recognized as a potentially beneficial CF management strategy [37]. It has been more than twenty five years since long-term placebo-controlled trials of prednisone [35] and ibuprofen [38,39] were begun, yet despite both drugs demonstrating proof of concept evidence of benefit on lung function, and more recently evidence for a survival benefit with ibuprofen [40], no anti-inflammatory therapy for CF has gained regulatory approval (Table 2). Industry sponsors interested in anti-inflammatories for CF face many challenges regarding suitable drug candidates, biomarkers, and study design issues related to efficacy endpoints [41].
Supported by the Canadian Institutes of Health Research and the Canadian Cystic Fibrosis Foundation.
L. Lands, R. Milner, and M. Corey all participated in the study design and the acquisition and interpretation of the data. A. Cantin participated in the study design. D. Manson performed the chest radiograph scoring. All authors read and approved the final version of the manuscript. L. Lands wrote the first draft and received no honorarium or payment of any kind.