Documents
European and International Clinical Research with Cyclamen Europaeum in Sinonasal Disease
MASSEGUR H.
ENT Department. Hospital de la Santa Creu
i Sant Pau. Barcelona
Present and Future of the Management of Sinonasal Disesase.
Madrid, 11 November 2007.
Keywords Present and Future of the Management of Sinonasal Disesase - PDF
INTRODUCTION
In recent years, a considerable body of evidence has been accumulated on the benefits of cyclamen extract, although it is expected that a lot more clinical data will become available about this natural product in the near future.
Dr. Humbert Massegur reviewed some of the clinical studies currently in process on the efficacy of cyclamen europaeum. As he pointed out, “if a drug is to have the backing of the scientific community and be recommended in the EP3OS guidelines as a first option, it must have prospective studies that confirm its efficacy in acute rhinosinusitis.”
Of the studies currently in progress on cyclamen extract, three stand out in particular: a multicentre trial in the United States in which 14 centres are taking part, the CYC-E-04 trial being performed in about ten German hospitals, and the CYC-E-03 multicentre study.
CYC-E-03 STUDY
This double-blind, multicentre (8 German centres), placebo-controlled, randomised study of the efficacy of Fluirespira Forte® (a single daily application in each nostril) in the treatment of acute rhinosinusitis (ARS) has included about 100 patients aged 18-65 years (moderate-severe ARS, according to the EP3OS criteria). The primary goal is to assess the clinical effect of treatment with Fluirespira Forte® in controlling the typical symptoms of acute rhinosinusitis. The secondary goal will be to analyse its safety profile.
The efficacy parameters assessed include the clinical symptoms, such as nasal obstruction, anterior or posterior mucous secretion, facial pain or pressure, and impaired sense of smell. The endoscopic signs are also analysed (mucopurulent secretion in the middle meatus, and oedema or nasal obstruction, mainly in the middle meatus). Other items assessed are the rate of administration of rescue medication or treatment failure, the complications associated with progression of the rhinosinusitis, the physician’s and patient’s overall opinion of the treatment, and the quality of the sleep related with the symptoms observed previously. Treatment duration is 15 days.
The study consists of three visits. Visit 1 is the baseline patient screening and recruitment visit. At this visit, the patient’s informed consent is obtained, his or her medical background is examined, the disease’s signs and symptoms are assessed, the patient is given instructions about how to use the product, and the concurrent medication is analysed. At the second visit (after 5-7 days), the symptoms are re-assessed, use of the treatment is monitored, the patient’s diary is collected and reviewed, and he or she is asked about the possible appearance of side effects and the concurrent medication is assessed. At the final visit, after 12-15 days, in addition to the basic tasks performed at the previous visit, both the patient and the physician provide a final assessment of the treatment, and the unused product is collected.
CYC-E-04 STUDY
The CYC-E-04 study compares the effect of Fluirespira Forte® (a single daily application in each nostril) with irrigation with saline solution every 8 hours for 15 days in postoperative care after endoscopic sinonasal surgery. The primary goal of this controlled, multicentre, randomised, single-blind study is to assess the treatment’s clinical effect in postoperative care; the secondary goal is to analyse its safety profile.
It has been calculated that about 100 patients aged 18-65 years undergoing endoscopic sinonasal surgery will be eventually included. The following efficacy parameters will be considered: the clinical symptoms (nasal obstruction, mucus secretion, hyposmia), the need for additional treatment or treatment failure, the appearance of possible complications (orbital, bleeding, intranasal,...) and overall assessment of the treatment by the physician and the patient.
Four visits have been scheduled during the study. The first (visit 0) is to screen the patients and will be used to analyse the signs and symptoms and assess the medical history. At visit 1, the plug is removed. At visit 2, performed 5-7 days after visit 1, the signs and symptoms are reviewed, use of the treatment is monitored, the patient’s diary is checked, and possible adverse effects are analysed.
Visit 3 is scheduled for 12-15 days after removing the plug. It will also include a final analysis of the patient’s condition, and an overall assessment by the physician and the patient.
NORTH AMERICAN MULTICENTRE STUDY
In the United States, a pilot study with cyclamen extract has been started whose purpose is to compare the effect of Fluirespira Forte® with placebo (a single daily application in each nostril in both patient groups) in ARS. The trial’s primary goal is to quantify progress by examination of the computerised axial tomography (CAT) on follow-up days 15 and 28. As Dr. Massegur explained, “this study will identify what changes take place between the baseline visit (day 1) and days 4 and 18 with respect to all of the symptoms assessed.”
The trial’s secondary goals are the following: assess the changes in the symptoms on different days (8, 15, 28), the time required for cure (which is defined as the absence of rhinosinusitis symptoms), the frequency of acute rhinosinusitis events during the three months of follow-up, and the presence or absence of mucopurulent secretion and inflamed mucosa at the end of the treatment period (nasal endoscopy).
50 patients, aged 18-70 years and with moderate- severe ARS will be included. Treatment duration will be 7 days. The main efficacy parameters will be the clinical symptoms observed during the study and the results obtained in the CAT.
Four visits have been scheduled (including the baseline visit), with telephone follow-up after the last visit. The patients will be monitored by CAT at the baseline visit, visit 3 (day 15) and the final visit (day 28). At visits 1 and 2, a nasal endoscopy will be performed and the secretions will be analysed at the laboratory (a nasal endoscopy will also be performed on the last day of follow-up).
The symptom score and the medication’s adverse effects will be assessed at each visit, and information will be obtained on the frequency of acute recurrences during the telephone follow-up.
CONCLUSION
By way of final conclusion, we can say that, once completed, these clinical studies in progress may provide a solid base for positioning Fluirespira Forte® (cyclamen europaeum extract) as a treatment for ARS with a degree of recommendation and scientific evidence A.
Present and Future of the Management of Sinonasal Disesase - Index
privacy policy | 2010© Hartington Pharmaceutical, S.L.U. all rights reserved | INTRANET