Rhinosinusitis: Developing guidance for clinical trials

Rhinosinusitis Initiative was developed by 5 national clinical research and patient care and provides templates for societies. The current guidance document is an expansion of the clinical trials in antimicrobial, anti-inflammatory, and 2004 publication Rhinosinusitis: Establishing definitions for symptom-relieving therapies for the following: (1) acute presumed bacterial rhinosinusitis, (2) chronic rhinosinusitis (CRS) without nasal polyps, (3) CRS with nasal polyps, and (4) classic allergic fungal rhinosinusitis. In addition to the templates for clinical trials and proposed study designs, the Rhinosinusitis Initiative has developed 6 appendices, which address (1) health outcomes, (2) nasal endoscopy and staging of CRS, (3) radiologic imaging, (4) microbiology, (5) laboratory measures, and (6) biostatistical methods.