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Completed

NCT Number: NCT02307825

Azithromycin for Patients With Chronic Rhinosinusitis Failing Medical and Surgical Therapy

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.

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Key information

Conditions

Chronic Rhinosinusitis High-risk Patient

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2W 1T8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Azithromycin

Drug

The drug will be taken three times a week for four months.

Other names: Zithromax

Placebo

Drug

The placebo will be taken three times a week for four months.

Other names: No other name

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. High-risk population

    Time frame: 12 months

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

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

  3. 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.

Sponsors and collaborators

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Other

Collaborators

  • Pfizer

Registry information

Official study title

Azithromycin as add-on Therapy in Patients Failing Medical and Surgical Treatment for Chronic Rhinosinusitis: a Double-blind, Randomized, Placebo-controlled Trial

Acronym: AZI-CRS

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 4, 2014
Registry last updated
Jan 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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