Considerations for the Conduct of Clinical Trials with Antiinflammatory Agents in Cystic Fibrosis. A Cystic Fibrosis Foundation Workshop Report.
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Summary
Before bringing new antiinflammatory drugs to clinical trial, preclinical safety studies must be conducted in disease-relevant models to assuage safety concerns, and although studies of antiinflammatory therapies must first establish safety in adults, subsequent studies must involve children, as they are most likely to reap the most benefit.
- Type
- review
- Published
- 2015-09-15
- Cited by
- 36
- References
- 71
- OpenAlex
- https://openalex.org/W1686244213
- Semantic Scholar
- https://api.semanticscholar.org/CorpusID:28071484
Keywords
Cystic fibrosis, Medicine, Intensive care medicine, Drug development, Cystic fibrosis transmembrane conductance regulator
References
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- Profound functional and signaling changes in viable inflammatory neutrophils homing to cystic fibrosis airways
- Lipoxins and new lipid mediators in the resolution of inflammation.
- Cannabinoid CB2 receptors: a therapeutic target for the treatment of inflammatory and neuropathic pain
- Ajulemic acid (IP-751): Synthesis, proof of principle, toxicity studies, and clinical trials
- Is cystic fibrosis a TH17 disease?
- Resolvins: Natural Agonists for Resolution of Pulmonary Inflammation
- A two-year randomized, placebo-controlled trial of dornase alfa in young patients with cystic fibrosis with mild lung function abnormalities.
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- Neutrophil cell death, activation and bacterial infection in cystic fibrosis
- Safety and early treatment effects of the CXCR2 antagonist SB-656933 in patients with cystic fibrosis.
Cited by
- Update on the spider and the fly: An extended commentary on “Oxidized LDL induced extracellular trap formation in human neutrophils via TLR-PKC-IRAK-MAPK and NADPH-Oxidase activation”
- Phase I Studies of Acebilustat: Pharmacokinetics, Pharmacodynamics, Food Effect, and CYP3A Induction
- Phase I Studies of Acebilustat: Biomarker Response and Safety in Patients with Cystic Fibrosis
- Interactions between Neutrophils and Pseudomonas aeruginosa in Cystic Fibrosis
- Vitamin D treatment modulates immune activation in cystic fibrosis
- Mapping Targetable Inflammation and Outcomes with Cystic Fibrosis Biomarkers
- Pseudomonas aeruginosa ExoU augments neutrophil transepithelial migration
- Airway Mucosal Host Defense Is Key to Genomic Regulation of Cystic Fibrosis Lung Disease Severity
- KB001-A, a novel anti-inflammatory, found to be safe and well-tolerated in cystic fibrosis patients infected with Pseudomonas aeruginosa.
- The EGFR-ADAM17 Axis in Chronic Obstructive Pulmonary Disease and Cystic Fibrosis Lung Pathology
- Towards Targeting the Aryl Hydrocarbon Receptor in Cystic Fibrosis
- Effects of an Antioxidant‐enriched Multivitamin in Cystic Fibrosis. A Randomized, Controlled, Multicenter Clinical Trial
- Inflammation in cystic fibrosis: An update
- EMPIRE-CF: A phase II randomized placebo-controlled trial of once-daily, oral acebilustat in adult patients with cystic fibrosis - Study design and patient demographics.
- Expression Profiling of Non-Coding RNA by Environmental Interactions in Innate Immunity
- Innovative Therapies for Cystic Fibrosis: The Road from Treatment to Cure
- Mucus accumulation in the lungs precedes structural changes and infection in children with cystic fibrosis
- Preclinical Modeling for Therapeutic Development in Cystic Fibrosis
- Resolvin D1 Reduces Lung Infection and Inflammation Activating Resolution in Cystic Fibrosis
- BUILDING GLOBAL DEVELOPMENT STRATEGIES FOR CF THERAPEUTICS DURING A TRANSITIONAL CFTR MODULATOR ERA
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