Chronic Rhinosinusitis Clinical Trial
Official title:
Azithromycin as add-on Therapy in Patients Failing Medical and Surgical Treatment for Chronic Rhinosinusitis: a Double-blind, Randomized, Placebo-controlled Trial
Justification: Chronic rhinosinusitis (CRS) is one of the most common inflammatory diseases
with an incidence and prevalence superior to 10%. Unfortunately, more than 30% of patients do
not respond to standard medical and surgical treatment, thus continuously increasing the
symptomatologic and socio-economic burden of this disease.
Hypothesis: The investigators believe that the addition of azithromycin (AZI) to the
treatment regimen of patients with refractory CRS failing conventional medico-surgical
treatment will be beneficial in a symptomatologic and endoscopic level.
Primary objective: 1- To evaluate whether Azithromycine 250 mg PO three times weekly is
effective in controlling signs and symptoms of CRS in high-risk patients unresponsive to
standard management after endoscopic sinus surgery (ESS) with budesonide irrigations.
Secondary objectives:
i) Validate a simple and concise treatment algorithm for patients refractory to standard CRS
treatment of ESS and BUDI, with the addition of low-dose AZI.
ii) Characterise and define the population deemed "high-risk" for standard CRS treatment
failure by evaluating: 1) demographics, 2) inflammatory states and 3) the nasal flora
microbiome of patients at the different follow-up points of this study.
iii) Explore the mechanisms of AZI by assessing the changes in inflammatory states and the
nasal flora microbiome associated with successful AZI therapy.
Methods: Inclusion of all patients admitted for endoscopic sinus surgery (ESS) for CRS
operated by the same surgeon (MD). Following their first postoperative visit (2 weeks), all
patients will receive nasal irrigations with budesonide (BUDI) twice daily for 4 months and
will be re-evaluated. If there is a failure of treatment, patients eligible to receive AZI
will be randomized in to two groups, AZI 250mg or a placebo three times a week for 4 months.
At every follow-up, complete endoscopic exams will be performed, along with sinus cultures
and brush cytology.
Population: All patients deemed "high-risk" with CRS admitted for ESS between October 2014
and October 2015.
n/a
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