Status:
COMPLETED
Azithromycin for Patients With Chronic Rhinosinusitis Failing Medical and Surgical Therapy
Lead Sponsor:
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsors:
Pfizer
Conditions:
Chronic Rhinosinusitis
High-risk Patient
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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...
Eligibility Criteria
Inclusion
- Patients with ≥1 of the following criteria:
- history of sinus surgery,
- first sinus surgery at ≤38 years of age,
- an absolute eosinophilia of ≥500 cells/mm,
- serum IgE levels of \>150 kIU/L,
- a Gram negative bacteria in a sinus culture,
- the presence of intra-operative eosinophilic mucin.
Exclusion
- Patients with cystic fibrosis, inverted papillomas, osteomata, mucoceles or other lesions of the base of skull will be excluded.
- Patients with an elevated cardiovascular disease risk will be excluded from the randomized clinical trial part of this study.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT02307825
Start Date
November 1 2014
End Date
December 31 2017
Last Update
January 26 2018
Active Locations (1)
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1
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2W 1T8