A consortium of 25 allergists and otorhinolaryngologists from five medical specialty societies in the United States has developed a guideline for designing clinical trials in the treatment of chronic rhinosinusitis.
Although the condition affects 30 million people nationwide, there has historically been a lack of consensus regarding its definition, and consensus is still lacking regarding standards of care for it. Therefore, according to the members of the consortium who produced the guidelines, a consensus regarding the design of clinical trials is an important next step to standardizing care.
The new guideline, Rhinosinusitis: Developing Guidance for Clinical Trials, consists of specific recommendations for such trials, and was published in November 2006 in both a supplement of the Journal of Allergy and Clinical Immunology (JACI) and Otolaryngology-Head and Neck Surgery (OTO-HNS).1,2 These are the official publications, respectively, of the American Academy of Allergy, Asthma, and Immunology (AAAAI) and the American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS). The other participating societies in the consortium are the American Academy of Otolaryngic Allergy (AAOA), the American College of Allergy, Asthma and Immunology (ACAAI), and the American Rhinologic Society (ARS). This is the group’s second collaboration. The first document was published in December 2004, also concurrently JACI and OTO-HNS.
Acute and Chronic Disease Differentiated
The guideline makes separate recommendations for trials that focus on different subtypes of rhinosinusitis:
- Acute bacterial rhinosinusitis;
- Chronic rhinosinusitis, with or without nasal polyps; and
- Allergic fungal rhinosinusitis.
The goal … has been to provide researchers with the needed methodologies which will promote better clinical studies that can lead to improved patient care, corresponding author, Eli O. Meltzer, MD, said in a statement. He is the Co-Director of the Allergy and Asthma Medical Group and Research Center in San Diego, Calif.
The current publication reviews the FDA’s role in drug trials and offers guidelines for rhinosinusitis clinical trials of various modalities, including antimicrobials, anti-inflammatory agents, and treatments that are designed for symptom relief or the blockage of mediators that promote symptoms. The guidelines also include recommendations of scoring instruments for symptoms, radiographs, endoscopic testing, and quality of life, as well as techniques for quantifying microbiologic factors, assessing inflammatory indices, and statistically measuring outcomes. The guidelines also provide a list of the various components of a rhinosinusitis clinical trial, including the title of the trial, the study design, the objectives, and the safety assessments.