Health TrialsbyHealthPanel

Evaluation of the Efficacy of Azithromycin in Idiopathic Purulent Oedematous Sinusitis in Adults

ConditionsSinusitis, ChronicSinus Infection Chronic
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCentre Hospitalier Intercommunal Creteil

About this trial

Purulent Oedematous Sinusitis (POS) is a particular form of chronic rhinosinusitis observed in 2% of the general population. In spite of its heavy impact on the quality of life, There is no established recommendation for the treatment of primary POS. Long-term low-dose macrolides are currently proposed for these forms of chronic rhinosinusitis when conventional treatments (local corticosteroids, saline rinsing, iterative short courses of antibiotics targeted on pathogens, and surgical opening and drainage) have failed. This treatment with macrolides is currently applied off-label.

This study aims to assess the efficacy of macrolides in POS. An extensive workup is fulfilled to exclude other forms of chronic rhinosinusitis (Th2 biased inflammatory diseases, allergic diseases) (allergy, nasosinusal polyposis) or those due to cystic fibrosis or immune deficiency.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient older than 18 years and less than 70 years of age

Nasal endoscopy showing bilateral and diffuse involvement associating edema of the mucosa of the nasal cavities and meatus with the presence of mucopurulent secretions in these areas

Nasosinus CT scan showing diffuse and bilateral pansinus opacities involving at least the maxillary sinuses and the anterior and posterior ethmoids

Persistent intractable purulent rhinosinusitis despite at least 2 antibiotic therapies

Disqualifiers

Pregnancy or breastfeeding

PCOS of identified primary cause (identified immune deficiency, cystic fibrosis, HIV)

Chronic non-purulent rhinosinusitis (nasosinusal polyposis, allergic rhinosinusitis)

Localized chronic suppurative rhinosinusitis (single sinus, unilateral, frontal or maxillary or sphenoidal)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Azithromycin Oral Tablet

    Drug

    Treatment assigned by randomization will be prescribed immediately. The active or placebo will be dispensed by the centre's pharmacy. Treatment will be taken in the morning or evening for 3 months.

  • Placebo

    Drug

    Treatment assigned by randomization will be prescribed immediately. The active or placebo will be dispensed by the centre's pharmacy. Treatment will be taken in the morning or evening for 3 months.

Treatment groups

230 Participants
are divided into 2 treatment groups
Group A: Azithromycin oral tabletExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Comparison of sinonasal outcome test (SNOT) 22

Comparison of the means of the Sinonasal Outcome Test (SNOT 22) specific quality of life scores after 3 months of treatment. (min = 0, max = 110)

Time frame
3 months

Secondary outcomes

1

Number of infectious rhinosinus exacerbations

The number of infectious rhinosinus exacerbations during the 3-month period,

Time frame
3 months
2

Number of courses of antibiotics used

Number of courses of antibiotics used during the 3-month period other than azithromycin or placebo

Time frame
3 months
3

Visual analog scales of symptoms

Visual analog scales (VAS) of symptoms (self-assessment) (nasal obstruction, rhinorrhea, facial pain, smell disorder, nasal hyperactivity, epistaxis). The VAS measures the intensity of pain on a scale from 0 to 10.

Time frame
6 months
4

Semi-quantitative symptom scale

Semi-quantitative 4-point symptom scale assessed by the practitioner (min = 0, max = 3)

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Intercommunal Creteil

Lead sponsor

Source ClinicalTrials.gov
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