Navigation Links
New Rhinosinusitis Clinical Trials Guidance Developed

More than 30 million Americans can attest that rhinosinusitis – an often recurring combination of congestion, discolored nasal discharge//, cough, and headache – seriously affects their quality of life.

A group of 25 physicians from five national medical societies has collaborated to design the first clinical trial guidelines for researchers working to find the most effective treatments for rhinosinusitis.

The U.S. Food and Drug Administration (FDA) has issued specific guidance documents for designing clinical trials of certain diseases, including acute bacterial sinusitis, but there has not been a guidance document put forth for chronic rhinosinusitis clinical trials. “Rhinosinusitis: Developing Guidance for Clinical Trials,” bridges this gap and offers researchers specific recommendations for rhinosinusitis clinical trials pertaining to acute bacterial rhinosinusitis, chronic rhinosinusitis with or without nasal polyps, and allergic fungal rhinosinusitis.

The guidelines will be published in November 2006 in a supplement of the American Academy of Allergy, Asthma and Immunology’s (AAAAI) Journal of Allergy and Clinical Immunology (JACI) and in the American Academy of Otolaryngology – Head and Neck Surgery/Foundation’s (AAO-HNS/F) white journal, Otolaryngology – Head and Neck Surgery. The corresponding author is Eli O. Meltzer, MD, Co-Director, Allergy and Asthma Medical Group and Research Center, San Diego, CA.

“The goal of the Rhinosinusitis Initiative has been to provide researchers with the needed methodologies which will promote better clinical studies that can lead to improved patient care,” Meltzer said.

Key components of the guidance include:
?Reviewing FDA’s role in drug trials.
?Presenting guidance for rhinosinusitis clinical trials of antimicrobials, anti-inflammatory treatment, and symptom reliever or mediator blocker treatments.
?Recommending scoring instruments for symptoms, rad iographs, endoscopic testing, and quality of life assessment.
?Recommending techniques for quantifying microbiologic factors, assessing inflammatory indices, and statistically measuring outcomes.

“Rhinosinusitis: Developing Guidance for Clinical Trials” offers a comprehensive list of rhinosinusitis clinical trial components ranging from the title of the trial, to study design, objectives and safety assessments.

The five societies involved in the collaboration include: the American Academy of Allergy, Asthma and Immunology (AAAAI); the American Academy of Otolaryngic Allergy (AAOA); the American Academy of Otolaryngology – Head and Neck Surgery/Foundation (AAO-HNS/F); the American College of Allergy, Asthma and Immunology (ACAAI); and the American Rhinologic Society (ARS).

This is the group’s second collaboration. Its original document, “Rhinosinusitis: Establishing Definitions for Clinical Research and Patient Care,” was published concurrently in the December 2004 editions of the JACI and OTO-HNS and can be found at The document, which led to “Rhinosinusitis: Developing Guidance for Clinical Trials,” was a catalyst for further research on this disease. The participants in the effort agree that promoting more research on both acute and chronic rhinosinusitis is essential, and a better understanding of the cause of these diseases is needed.


Related medicine news :

1. Clinical trials need to be more frank
2. Physicians Lack Clinical Guidelines For Treating Elderly With Multiple Illnesses
3. The Growing Rise In Clinical Research Could Lead To A Compromise In Quality Of Research And Ethics
4. Clinical Comparisons Between ADHD Drugs Are Less
5. A Novel System For Clinical Banking Of Umbilical Cord Blood
6. Clinical Renal Trails Do Not Have Sufficient Women Participants
7. Clinical Trials of New Drug Febuxostat Show Promise in Gout Treatment
8. Clinical Trials Of New Anti-Cancer Drug To Be Initiated In New Zealand
9. Green Tea Consumption Found To Improve Clinical Outcome In Cancer Patients
10. Cancer Clinical Research in India
11. New Generation Clinical Trials Could Save Time And Money, Improve Patient Care
Post Your Comments:

(Date:6/25/2016)... ... 25, 2016 , ... Austin residents seeking Mohs surgery services, can now turn ... to Dr. Russell Peckham for medical and surgical dermatology. , Dr. Dorsey brings specialization ... selective fellowship in Mohs Micrographic Surgery completed by Dr. Dorsey was under the direction ...
(Date:6/25/2016)... Beach, CA (PRWEB) , ... June 25, 2016 , ... ... UCLA with Magna Cum Laude and his M.D from the David Geffen School of ... Diego and returned to Los Angeles to complete his fellowship in hematology/oncology at the ...
(Date:6/24/2016)... ... ... A recent article published June 14 on E Online details ... to state that individuals are now more comfortable seeking to undergo not only the ... and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians (BHP) notes ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... and Scientific Sessions in Dallas that it will receive two significant new grants ... grants came as PHA marked its 25th anniversary by recognizing patients, medical professionals ...
(Date:6/24/2016)... ... ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join The ‘Business for ... $12 an hour by 2020 and then adjusting it yearly to increase at the same ... wage, assure the wage floor does not erode again, and make future increases more predictable. ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016  Collagen Matrix, ... design, development and manufacturing of collagen and mineral ... announced today that Bill Messer has ... Marketing to further leverage the growing portfolio of ... devices. Bill joins the Collagen Matrix ...
(Date:6/24/2016)... Va. , June 24, 2016 The ... set of recommendations that would allow biopharmaceutical ... (HCEI) with entities that make formulary and coverage decisions, ... the "value" of new medicines. The recommendations ... does not appear on the drug label, a prohibition ...
(Date:6/24/2016)... 24, 2016   Pulmatrix, Inc ., (NASDAQ: ... inhaled drugs, announced today that it was added to ... its comprehensive set of U.S. and global equity ... an important milestone for Pulmatrix," said Chief Executive Officer ... of our progress in developing drugs for crucial unmet ...
Breaking Medicine Technology: