Trial reportArchives of disease in childhood1997
Randomised controlled trial of inhaled corticosteroids (fluticasone propionate) in cystic fibrosis.
Trial report in Archives of disease in childhood, 1997. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 1 synthesis or guideline pooled it, 99 citations in OpenAlex.
- Inhaled corticosteroids for cystic fibrosis.The Cochrane database of systematic reviews · 2019Pooled it
- Do inhaled corticosteroids impair long-term growth in prepubertal cystic fibrosis patients?European journal of pediatrics · 2007Trial
- Trial
- Treatable traits and challenges in the clinical management of non-tuberculous mycobacteria lung disease in people with cystic fibrosis.Respiratory research · 2023Review
- Alveolar inflammation in cystic fibrosis.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2010Article
- Macrorheology of cystic fibrosis, chronic obstructive pulmonary disease & normal sputum.Respiratory research · 2009Article
- The role of inhaled corticosteroids in the management of cystic fibrosis.Paediatric drugs · 2009Review
- Highlights of a workshop to discuss targeting inflammation in cystic fibrosis.Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society · 2009Review
- Anti-inflammatory therapies for cystic fibrosis-related lung disease.Clinical reviews in allergy & immunology · 2008Review
- Glucocorticoid receptor gene polymorphisms associated with progression of lung disease in young patients with cystic fibrosis.Respiratory research · 2007Article
- Review
- Cystic fibrosis lung disease: genetic influences, microbial interactions, and radiological assessment.Pediatric radiology · 2005Review
- Measuring and reporting quality of life outcomes in clinical trials in cystic fibrosis: a critical review.Health and quality of life outcomes · 2005Review
- Leukotriene receptor antagonists in children with cystic fibrosis lung disease : anti-inflammatory and clinical effects.Paediatric drugs · 2005Review
- Quality of life in children and adolescents with cystic fibrosis: implications for optimizing treatments and clinical trial design.Paediatric drugs · 2003Review
- The role of inflammation in the pathophysiology of CF lung disease.Clinical reviews in allergy & immunology · 2002Review
- Monitoring inflammation in CF. Cytokines.Clinical reviews in allergy & immunology · 2002Review
- Macrolides in the respiratory tract in cystic fibrosis.Journal of the Royal Society of Medicine · 2002Review
- Cystic fibrosis.Thorax · 2001Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundControlling lung inflammation may be the key to improving morbidity and mortality in cystic fibrosis.
objectiveTo assess the effects of inhaled corticosteroids on lung inflammation in cystic fibrosis.
designDouble blind placebo controlled randomised sequence crossover trial. Fluticasone propionate (400 micrograms/day) was given as a dry powder inhaler for six weeks with a four week washout period before crossover. OUTCOME MEASURES: Sputum inflammatory markers (interleukin-8, tumour necrosis factor-alpha (TNF-alpha) and neutrophil elastase-both free and bound to alpha 1-antiprotease), sputum interleukin-10, lung function, and symptomatology. SUBJECTS: Twenty three children from a regional cystic fibrosis centre were enrolled into the study, with mean age 10.3 years (range 7 to 17 years) and mean baseline forced expiratory volume in one second (FEV1) of 64% (range 21% to 102%) predicted for sex and height. One patient was excluded for non-compliance to the study protocol.
resultsNo significant benefit was shown for the use of fluticasone propionate in any of the outcomes. For sputum interleukin-8 there was an estimated true treatment median difference of 142 pg/ml (95% confidence interval (CI) 8 to 2866 pg/ml) in favour of placebo; while for maximal expiratory flow at 25% (MEF25%) remaining forced vital capacity predicted for sex and height there was a 15 percentage points (pp) (95% CI 4 to 26 pp) mean treatment difference in favour of placebo. Sputum interleukin-10 was undetected in any samples and unaffected by fluticasone propionate. Neither atopic status, baseline FEV1, nor concomitant DNase therapy had any effect on response to treatment.
conclusionsLack of benefit from fluticasone propionate was most likely due to failure of the drug to penetrate the viscid mucus lining the airways. It is suggested a large multicentre trial with higher doses given for a longer time by a different delivery system is required to assess efficacy.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.