From the Guidelines
Pediatric clinical trials should prioritize the use of pediatric-specific cough management protocols or algorithms to ensure the safety and effectiveness of treatments for children with chronic cough, as recommended by the most recent and highest quality study 1. When managing chronic cough in children, it is essential to consider the unique physiological needs and potential risks associated with various treatments. The use of cough algorithms or pathways can lead to earlier diagnosis and reduce morbidity, unnecessary costs, and medication use associated with chronic cough. Key considerations in pediatric clinical trials for chronic cough include:
- Defining chronic cough as the presence of daily cough of at least 4 weeks in duration in children aged ≤ 14 years 1
- Assessing the effect of cough on the child and the family as part of the clinical consultation 1
- Using a systematic approach to determine the cause of the cough, such as using a validated guideline 1
- Basing the management or testing algorithm on cough characteristics and the associated clinical history 1
- Avoiding empirical approaches aimed at treating upper airway cough syndrome, gastroesophageal reflux disease, and/or asthma unless other features consistent with these conditions are present 1 By following these guidelines and prioritizing the use of pediatric-specific protocols, pediatric clinical trials can provide valuable insights into the safe and effective treatment of chronic cough in children, ultimately improving their quality of life and reducing morbidity and mortality.
From the Research
Clinical Trials in Pediatrics
- Clinical trials in children are essential to increase our knowledge of the effects of medicines and to prevent the delayed or non-use of beneficial therapies 2
- Pediatric clinical trials commonly experience recruitment challenges, including limited number of patients and investigators, and a competitive research landscape 3
- The use of Bayesian statistics can improve pediatric trial feasibility by reducing trial size and enabling drugs to be labeled appropriately for children 3
Asthma Treatment in Pediatrics
- Inhaled fluticasone propionate (FP) is effective in treating chronic asthma in children, with improvements in FEV1, morning PEF, symptom scores, and reduction in rescue beta-2 agonist use 4
- High-dose FP can increase the number of patients who can withdraw from prednisolone, but is also associated with an increased likelihood of oropharyngeal side effects 4
- The combination of FP and salmeterol is a cost-effective strategy for treating persistent asthma, with lower daily costs and greater efficacy compared to FP plus montelukast 5
Design and Conduct of Pediatric Clinical Trials
- Pediatric phase I/II protocols require unique consideration, including careful construction of trial design and interpretation 6
- Problems can arise when trials are not designed with the pediatric patient in mind, highlighting the need for trained pediatric investigators to be involved in trial design and interpretation 6