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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02307825
Recruitment Status : Completed
First Posted : December 4, 2014
Last Update Posted : January 26, 2018
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

Tracking Information
First Submitted Date  ICMJE November 11, 2014
First Posted Date  ICMJE December 4, 2014
Last Update Posted Date January 26, 2018
Actual Study Start Date  ICMJE November 2014
Actual Primary Completion Date August 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2014)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Azithromycin for Patients With Chronic Rhinosinusitis Failing Medical and Surgical Therapy
Official Title  ICMJE Azithromycin as add-on Therapy in Patients Failing Medical and Surgical Treatment for Chronic Rhinosinusitis: a Double-blind, Randomized, Placebo-controlled Trial
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 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Rhinosinusitis
  • High-risk Patient
Intervention  ICMJE
  • Drug: Azithromycin
    The drug will be taken three times a week for four months.
    Other Name: Zithromax
  • Drug: Placebo
    The placebo will be taken three times a week for four months.
    Other Name: No other name
Study Arms  ICMJE
  • Active Comparator: Azithromycin
    Patients will receive the active study drug, azithromycin, as well as sinus irrigations with budesonide.
    Intervention: Drug: Azithromycin
  • Placebo Comparator: Placebo
    Patients will receive a placebo as well as sinus irrigations with budesonide.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2017)
129
Original Estimated Enrollment  ICMJE
 (submitted: December 3, 2014)
150
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date August 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02307825
Other Study ID Numbers  ICMJE 14.140
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre hospitalier de l'Université de Montréal (CHUM)
Study Sponsor  ICMJE Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator: Martin Y Desrosiers, MD, FRCSC CHUM
PRS Account Centre hospitalier de l'Université de Montréal (CHUM)
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP