Rhinosinusitis: Developing guidance for clinical trials
2006; Elsevier BV; Volume: 118; Issue: 5 Linguagem: Inglês
10.1016/j.jaci.2006.09.005
ISSN1097-6825
AutoresEli O. Meltzer, Daniel L. Hamilos, James A. Hadley, Donald C. Lanza, Bradley F. Marple, Richard A. Nicklas, Allen Adinoff, Claus Bachert, Larry Borish, Vernon M. Chinchilli, Melvyn Danzig, Berrylin J. Ferguson, Wytske J. Fokkens, Stephen G. Jenkins, Valerie J. Lund, Mahmood F. Mafee, Robert M. Naclerio, Ruby Pawankar, Jens U. Ponikau, Mark S. Schubert, Raymond G. Slavin, Michael G. Stewart, Alkis Togias, Ellen R. Wald, Birgit Winther,
Tópico(s)Nasal Surgery and Airway Studies
ResumoThe Rhinosinusitis Initiative was developed by 5 national societies. The current guidance document is an expansion of the 2004 publication “Rhinosinusitis: Establishing definitions for clinical research and patient care” and provides templates for clinical trials in antimicrobial, anti-inflammatory, and 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. The Rhinosinusitis Initiative was developed by 5 national societies. The current guidance document is an expansion of the 2004 publication “Rhinosinusitis: Establishing definitions for clinical research and patient care” and provides templates for clinical trials in antimicrobial, anti-inflammatory, and 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. The development of sound clinical research trials that target the various causes of rhinosinusitis is necessary to gain a better understanding of how to effectively prevent and treat the detrimental health consequences associated with this condition. Recognizing this need, 5 national societies—the American Academy of Allergy, Asthma, and Immunology; the American Academy of Otolaryngic Allergy; the American Academy of Otolaryngology–Head and Neck Surgery; the American College of Allergy, Asthma, and Immunology; and the American Rhinologic Society—convened a group of 30 physicians in 2003 and, in a consensus document, “Rhinosinusitis: Establishing definitions for clinical research and patient care,” proposed definitions and drafted initial clinical trial designs for several classifications of rhinosinusitis.1Meltzer E.O. Hamilos D.L. Hadley J.A. Lanza D.C. Marple B.F. Nicklas R.A. et al.Rhinosinusitis: establishing definitions for clinical research and patient care.Otolaryngol Head Neck Surg. 2004; 131: S1-S62Crossref PubMed Scopus (199) Google ScholarThe 5-society collaboration is now referred to as the Rhinosinusitis Initiative. This document is the latest product of this initiative, expanding on the previous work of the group by developing a template for clinical trials for antimicrobial, anti-inflammatory, and symptom-relieving therapies for acute presumed bacterial rhinosinusitis (ABRS), chronic rhinosinusitis (CRS) without nasal polyps (CRSsNP), CRS with nasal polyps (CRSwNP), and classic allergic fungal rhinosinusitis (AFRS).1Meltzer E.O. Hamilos D.L. Hadley J.A. Lanza D.C. Marple B.F. Nicklas R.A. et al.Rhinosinusitis: establishing definitions for clinical research and patient care.Otolaryngol Head Neck Surg. 2004; 131: S1-S62Crossref PubMed Scopus (199) Google ScholarMethodsThe guidelines set forth in this article were developed by using consensus discussions and rigorous literature review. Twenty-seven individuals were selected to serve on this Rhinosinusitis Initiative Committee. They were chosen by the Editorial Committee, whose members represented the 5 national societies, because each one was a research scientist deemed to be an expert in clinical trials. These specialists were from the disciplines of allergy/immunology, otolaryngology, infectious disease, radiology, and biostatistics. The Rhinosinusitis Initiative Committee met in Bethesda, Maryland, from February 25, 2005, to February 27, 2005, to consider various trial components and designs and to produce the following recommendations. The attendees were initially divided into 3 working groups. Each group provided rationales and recommendations for the inclusion of specific trial components pertaining to the 4 target rhinosinusitis disease states: (1) ABRS; (2) CRSsNP; (3) CRSwNP; and (4) AFRS. These were then reviewed and revised in the full committee discussions. If consensus was difficult to reach because of dissenting opinions, a majority vote was taken and recorded. A systematic literature review was conducted based on key words determined during the 2005 conference, and the Editorial Committee selected appropriate source documents. In drafting this guidance, the existing grade of evidence for each issue was considered, but no further elaboration of them occurred. Many have been recently reviewed in the excellent European Academy of Allergology and Clinical Immunology position paper.2Fokkens W. Lund V. Bachert C. Clement P. Hellings P. Holmstrom M. et al.EAACI position paper on rhinosinusitis and nasal polyps executive summary.Allergy. 2005; 60: 583-601Crossref PubMed Scopus (223) Google Scholar An unrestricted educational grant was provided by Schering-Plough Corporation to the American Academy of Allergy, Asthma and Immunology and the journals to help pay the costs of the conference and the supplements. The grant agreement prohibited Schering-Plough from having any role in the selection of the attendees, in the design of the content and conduct of the meeting, and/or in the preparation of the manuscript. Reflective of their experience, many of the participants had extensive industry relationships. During the initial part of the meeting, the requirement for each participant to be objective and set aside bias was reviewed. A great deal of self-policing was manifest in group discussions. During the conference, broad categories of therapeutic agents were discussed rather than specific generic or brand-name products.This guidance should be reviewed as a work in progress. Although they have been endorsed by each of the participating societies, they should not be considered authoritative by medical organizations, commercial companies, or regulatory agencies. Some elements of trial designs remain controversial and will require further discussion. However, it is the sincere hope of this task force that this initiative will promote better clinical research and improved patient care for individuals with rhinosinusitis.US Food and Drug Administration: Drug development and clinical trial design guidanceThe role of the US Food and Drug Administration (FDA) is to ensure a drug is proved safe and effective for clinical use. As a result, this agency adheres to strict standards, and clinical trials must be designed appropriately to document that an investigational drug or an approved drug under examination for a new indication is evaluated for drug safety and efficacy.The FDA requires investigations be “adequate and well-controlled,” defined by the Code of Federal Regulations (21 CFR 314.126)3US Food and Drug Administration. Title 21 Code of Federal Regulations. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm. Accessed June 1, 2006.Google Scholar as “evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.”Drugs are approved based on both clinically and statistically significant results of well-designed clinical trials, and in general, the FDA requires confirmatory evidence from 2 independent trials to demonstrate the efficacy of new drug products. Many factors must be taken into consideration to demonstrate a statistically significant result, and any benefits recorded from drug effectiveness must be well supported while minimizing the possibility of fraud, bias, or chance.There are 3 components of trial design the FDA considers necessary for an adequate and well-controlled investigation4Katz R. FDA: evidentiary standards for drug development and approval.NeuroRx. 2004; 1: 307-316Crossref PubMed Scopus (25) Google Scholar: (1) the objective of the study must be clearly stated, coupled with a summary of the methods used for analysis of the trial results; (2) the design must permit quantitative assessment of drug effectiveness by a valid comparison with a control group; and (3) the study protocol should accurately define the design and duration of the study, sample size issues, and whether treatments are parallel or sequential. Furthermore, the FDA requires clinical trials to provide a clear description of the method of patient selection and treatment assignment, depict methods for bias minimization (eg, blinding), and describe appropriate measures for assessing patient response.Evidentiary requirements for drug approval focus on proving statistical significance and avoiding the type I error (incorrectly assuming a drug is effective). Detailed statistical plans and analytic methodologies are required. Before data analysis, the null hypothesis is in place. If the research objective is to assess treatment effectiveness, the null hypothesis states there is no difference between the control group and the treatment group. The P value is calculated under the assumption that the null hypothesis is true and represents the probability of achieving the observed data result or something more extreme. If the P value is less than .05, the finding is considered statistically significant because the probability of the type I error is small. In such a case, the null hypothesis is rejected, and researchers often conclude the observed result might not be due to a type I error but represents a real treatment effect.The FDA prefers that trials designed to show drug effectiveness designate a single primary outcome, although 2 outcomes might be appropriate. A single primary outcome is preferred because multiple outcome measures increase the overall probability of a type I error.It is also important to note that acceptance of surrogate end points for determination of drug effectiveness is growing. A surrogate end point is defined as “a laboratory measure or other test that has no direct or obvious relationship to how a patient feels or to any clinical symptom, but on which a beneficial effect of a drug is presumed to predict a desired beneficial effect on such a clinical outcome.”5Katz R. Biomarkers and surrogate markers: an FDA perspective.NeuroRx. 2004; 1: 189-195Crossref PubMed Scopus (130) Google Scholar There are 2 types of surrogate end points: validated and unvalidated. Validated surrogate end points are tests for which there is adequate evidence that a drug effect on the measure predicts the clinical benefit desired (eg, decrease in blood pressure to measure antihypertensive drugs). Unvalidated surrogate end points are measures for which evidence does not exist that a drug effect on the measure predicts the desired clinical outcome. The FDA prefers the use of validated surrogate end points; however, in 1992, a regulation was established that allowed approval of a treatment based on its effects on an unvalidated surrogate end point. This regulation applies to serious or life-threatening illnesses.The FDA has issued specific “guidance documents” for the purposes of designing clinical trials of certain diseases, including a draft guidance for studying acute bacterial sinusitis. No guidance document currently exists for chronic (rhino)sinusitis, and this condition has not been officially defined by the FDA; however, the FDA has reviewed several industry-sponsored trials for forms of chronic sinusitis, and recently, 2 of these trials lead to drug approval for the indication of nasal polyposis.6Small C.B. Hernandez J. Reyes A. Schenkel E. Damiano A. Stryszak P. et al.Efficacy and safety of mometasone furoate nasal spray in nasal polyposis.J Allergy Clin Immunol. 2005; 116: 1275-1281Abstract Full Text Full Text PDF PubMed Scopus (62) Google Scholar, 7Stjarne P. Mosges R. Jorissen M. Passali D. Bellussi L. Staudinger H. et al.A randomized controlled trial of mometasone furoate nasal spray for the treatment of nasal polyposis.Arch Otolaryngol Head Neck Surg. 2006; 132: 179-185Crossref PubMed Scopus (55) Google Scholar Existing barriers to clinical trials in these conditions include the following: current controversy regarding the terms rhinosinusitis versus sinusitis, the lack of consensus regarding the classification and definitions of these conditions, and the lack of consensus regarding end points that should be applied to clinical trials of these conditions. As a result, the trial designs outlined in this document should be viewed as guidance based on expert opinion. Before any trial for rhinosinusitis is initiated, the investigator/sponsor should plan a prestudy meeting with the FDA or other appropriate regulatory agency to review the protocol and address controversial areas.Clinical trial components guideThis document provides guidance for research trials in 4 disease categories of rhinosinusitis (Table I). It is formatted in an outline fashion to address 3 therapeutic modalities, namely antimicrobial agents, anti-inflammatory medications, and symptom-relieving treatments, for each of the 4 disease categories (Table II). The Rhinosinusitis Initiative conference attendees discussed different types of trials, and rather than presenting duplicate anti-inflammatory trial designs for “intranasal corticosteroids” under CRSsNP and CRSwNP, intranasal corticosteroids are covered under CRSsNP, and oral corticosteroids are addressed under CRSwNP. Similarly, under the category of “symptom reliever,” intranasal decongestants are covered under ABRS, and leukotriene (LT) modifiers are discussed under CRSwNP and AFRS. This minimized the duplication of protocols for different conditions and expanded the scope of trial designs that were covered. Sufficient detail is provided in each protocol, such that information not covered can be culled from the other protocols.Table IRhinosinusitis consensus research definitions1Meltzer E.O. Hamilos D.L. Hadley J.A. Lanza D.C. Marple B.F. Nicklas R.A. et al.Rhinosinusitis: establishing definitions for clinical research and patient care.Otolaryngol Head Neck Surg. 2004; 131: S1-S62Crossref PubMed Scopus (199) Google Scholar and clinical trial guidelinesType of rhinosinusitisCriteria for diagnosisABRSCRSsNPCRSwNPAFRSPattern of symptoms•Symptoms present for a minimum of 10 d up until a maximum of 28 d OR•Severe disease∗Patients who have intracranial extension, have orbital cellulitis, or require hospitalization are considered to have severe disease and should be excluded from clinical trials of uncomplicated ABRS. (presence of purulence for 3-4 d with high fever) OR•Worsening disease (symptoms that initially regress but worsen within the first 10 d)Symptoms present for ≥12 wkSymptoms present for ≥12 wkSymptoms present for ≥12 wkSymptoms for diagnosisRequires:•Anterior and/or posterior mucopurulent drainage PLUS•Nasal obstruction OR•Facial pain/pressure/fullnessRequires ≥2 of the following symptoms:•Anterior and/or posterior mucopurulent drainage•Nasal obstruction•Facial pain/pressure/fullnessRequires ≥2 of the following symptoms:•Anterior and/or posterior mucopurulent drainage•Nasal obstruction•Decreased sense of smellRequires ≥1 of the following symptoms:•Anterior and/or posterior drainage•Nasal obstruction•Decreased sense of smell•Facial pain/pressure/fullnessObjective documentationRequires either:•Nasal airway examination for mucopurulent drainage:(1)beyond vestibule by either anterior rhinoscopy or endoscopy OR(2)posterior pharyngeal drainage, OR•Radiographic evidence of acute rhinosinusitisRequires both:•Endoscopy to exclude the presence of polyps in middle meatus and document presence of inflammation, such as discolored mucus or edema of middle meatus or ethmoid area AND•Evidence of rhinosinusitis on imaging by CTRequires both:•Endoscopy to confirm presence of bilateral polyps in middle meatus AND•Imaging by CT with confirmation of bilateral mucosal diseaseRequires:•Endoscopy to document presence of allergic mucin (pathology showing sparse fungal hyphae with degranulating eosinophils) and inflammation, such as edema of middle meatus or ethmoid area or NPs•Evidence of rhinosinusitis by CT or MRI•Evidence of fungal specific IgE (skin test or in vitro blood test)•No histologic evidence of fungal invasion when risk factors for invasive fungal disease are present.Other possible documentation (not required):•Fungal culture•Total serum IgE level•Imaging by more than one technique (CT or MRI) highly suggestive of AFRS∗ Patients who have intracranial extension, have orbital cellulitis, or require hospitalization are considered to have severe disease and should be excluded from clinical trials of uncomplicated ABRS. Open table in a new tab Table IIMaster list of clinical trial guidance presented based on disease categoryI. ABRSII. CRSsNPIII. CRSwNPIV. AFRSA. AntimicrobialFig 1 Example: Oral antibioticFig 2, Fig 3, Fig 4 Example: Systemic or topical antimicrobialFig 3, Fig 4 Example: Long-term antimicrobialFig 3, Fig 4 Example: Topical or oral antifungalB. Anti-inflammatoryFig 1 Example: Intranasal corticosteroidFig 2, Fig 3, Fig 4 Example: Intranasal corticosteroidFig 2, Fig 3, Fig 4 Example: Oral corticosteroidFig 2, Fig 3, Fig 4 Example: Systemic immunomodulatorC. Symptom reliever or mediator blockerFig 1 Example: Intranasal decongestantFig 2, Fig 3, Fig 4 Example: Intranasal hypertonic salineFig 3, Fig 4 Example: Aspirin desensitization, LT modifierFig 3, Fig 4 Example: LT modifier Open table in a new tab A key issue in designing trials for rhinosinusitis is the selection of outcome measures. There are multiple options (eg, symptoms, quality of life [QOL], imaging, and laboratory tests) discussed throughout the document. Although this document is the work of a collaborative task force, it should be noted there was no attempt to develop a standard or recommended outcome or level of improvement. In each section recommended outcome measures were taken directly from the discussion in each subgroup meeting. In general, subgroups concluded that symptom severity is an important outcome and proposed different variations on a similar theme (eg, reduction in symptom score of 50%, clinically significant reduction, and full resolution of symptoms). Therefore the issue of outcome quantification should be considered carefully in trial design.Tips for navigating this document effectivelyTable III is the master list of clinical trial components and is essential for navigation of each of the 12 clinical trial guidance documents. 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