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Azithromycin for Patients With Chronic Rhinosinusitis Failing Medical and Surgical Therapy (AZI-CRS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:
NCT02307825
First received: November 11, 2014
Last updated: June 15, 2017
Last verified: September 2016
  Purpose

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.


Condition Intervention Phase
Chronic Rhinosinusitis High-risk Patient Drug: Azithromycin Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Azithromycin as add-on Therapy in Patients Failing Medical and Surgical Treatment for Chronic Rhinosinusitis: a Double-blind, Randomized, Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by Centre hospitalier de l'Université de Montréal (CHUM):

Primary Outcome Measures:
  • Signs and symptoms outcome to Azithromycin [ Time Frame: 4 months ]
    Evaluate if Azithromycin 250mg by mouth, three times a week for four months will be effective in controlling signs and symptoms of chronic rhinosinusitis patients at a high-risk of recurrence following standard medical and surgical treatment. Disease level is evaluated through nasal endoscopy.


Secondary Outcome Measures:
  • Treatment algorithm validation [ Time Frame: 8 months ]
    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.

  • High-risk population [ Time Frame: 12 months ]

    Characterise and define the population deemed "high-risk" for standard CRS treatment failure by evaluating:

    1. The demographics of this population
    2. The inflammatory state of patients at the different follow-ups (serum biomarkers)
    3. The microbiome of the nasal flora of patients at the different follow-ups (microbial cultures)

  • Azithromycin mechanism of action [ Time Frame: 12 months ]
    Explore the mechanisms of action of AZI by assessing the changes in inflammatory states (serum biomarkers and epithelium inflammation) and the nasal flora microbiome (microbial cultures) associated with successful AZI therapy.


Enrollment: 129
Actual Study Start Date: November 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Azithromycin
Patients will receive the active study drug, azithromycin, as well as sinus irrigations with budesonide.
Drug: Azithromycin
The drug will be taken three times a week for four months.
Other Name: Zithromax
Placebo Comparator: Placebo
Patients will receive a placebo as well as sinus irrigations with budesonide.
Drug: Placebo
The placebo will be taken three times a week for four months.
Other Name: No other name

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02307825

Locations
Canada, Quebec
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2W 1T8
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Pfizer
Investigators
Principal Investigator: Martin Y Desrosiers, MD, FRCSC CHUM
  More Information

Publications:
Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT02307825     History of Changes
Other Study ID Numbers: 14.140
Study First Received: November 11, 2014
Last Updated: June 15, 2017

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):
Azithromycin
Endoscopic sinus surgery

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on June 23, 2017