Evaluating balloon sinuplasty for maxillary sinusitis

A Placebo Controlled Randomised Study of the Balloon Sinuplasty Efficiency in Chronic or Recurrent Maxillary Rhinosinusitis.

This study is testing if balloon sinuplasty can help people with chronic or recurrent maxillary sinusitis feel better compared to a fake surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 69 Years
• Sex: All
• Sponsor: Tampere University Hospital (Academic / other)
• Locations: 1 site (Tampere)
• Trial ID: NCT04645511 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, randomized, placebo-controlled, double-blinded study that aims to assess the efficacy of balloon sinuplasty in treating chronic and recurrent maxillary sinusitis. It involves 120 patients who are divided into two groups based on their condition: chronic maxillary sinusitis and recurrent maxillary sinusitis. Participants will receive either the balloon sinuplasty treatment or a sham surgery to determine the actual benefits of the procedure. The study also seeks to evaluate the impact of the treatment on Eustachian tube dysfunction.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 70 with chronic or recurrent maxillary rhinosinusitis who have not responded to prior corticosteroid treatment.

Not a fit: Patients with chronic rhinosinusitis accompanied by nasal polyps or significant inflammation in other sinuses may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from chronic or recurrent maxillary sinusitis.

How similar studies have performed: Previous studies have shown promising results for balloon sinuplasty in sinusitis treatment, indicating that this approach is supported by existing evidence.

Eligibility criteria

Inclusion Criteria:

* Patients at least 18 years old and younger than 70 years old
* Patients willing to participate in the study
* Patients whose diseases fill the definitions of chronic or acute recurrent maxillary rhinosinusitis
* Patients with chronic maxillary rhinosinusitis has not responded to a 3-month trial of topical corticosteroid treatment
* SNOT-22 points 8 or more in chronic maxillary rhinosinusitis
* In recurrent acute maxillary rhinosinusitis, no SNOT-22 point limits are used
* Modified Lund-Mackay inclusion criteria in chronic rhinosinusitis group:

  1. Maxillar 0-2
  2. Anterior Ethmoid 0-2
  3. Posterior Ethmoid 0-1
  4. Sphenoid 0-1
  5. Frontal 0-1
  6. Ostiomeatal complex 0 or 2

Exclusion Criteria:

* Chronic rhinosinusitis with nasal polyps
* Notable inflammation in the ethmoidal, sphenoidal or frontal sinuses along with maxillary sinusitis
* Previous nasal surgery
* Sinonasal tumor
* Maxillary rhinosinusitis caused by a dental problem
* Facial pain caused by other etiologies
* Cystic fibrosis
* Gross immunodeficiency
* Congenital mucociliary problems
* Non-invasive fungal balls and invasive fungal disease
* Systemic vasculitis and granulomatous disease
* Severe systemic diseases
* Malignancies
* Pregnancy

Definitions:

Recurrent acute maxillary rhinosinusitis:

* 4 or more episodes (\< 12 weeks) of acute rhinosinusitis with typical symptoms per year and no persistent symptoms between the rhinosinusitis episodes (Chan and Kuhn 2009)
* The diagnosis of the recurrent episodes of acute rhinosinusitis have been made with the following criteria:

  * Increase of symptoms after 5 days or persistent symptoms after 10 days and
  * During the episode, 2 or more symptoms, one of which should be either nasal blockage/obstruction or nasal discharge (anterior/posterior nasal drip)
  * +/- facial pain/pressure
  * +/- reduction or loss of smell (Fokkens et al. 2012) and either
  * Signs of mucopurulent discharge primarily from the middle meatus seen in anterior rhinoscopy or nasoendoscopy and/or
  * Oedema/mucosal obstruction primarily seen in the middle meatus in anterior rhinoscopy or nasoendoscopy and/or
  * Signs of mucopurulent discharge seen in the nasopharynx or posterior oropharynx and/or
  * Signs of acute maxillary sinusitis is seen in sinus X-rays or CT/CBCT scans and/or
  * Signs of acute maxillary sinusitis seen in the sinus ultrasound
* No signs of mucosal disease at nasoendoscopy during the asymptomatic period
* At most, minor signs of inflammation in the maxillary sinuses and/or ostiomeatal complex in CT/CBCT scans during the asymptomatic period

  * Maximum 2-3 mm mucosal thickness in maxillary sinus medial and lateral wall

Chronic maxillary rhinosinusitis:

* Presence of typical symptoms of chronic rhinosinusitis for equal or longer than 12 weeks

  * 2 or more symptoms, one of which should be either nasal blockage/obstruction or nasal discharge (anterior/posterior nasal drip)
  * +/- facial pain/pressure
  * +/- reduction or loss of smell and either
  * Endoscopic signs of mucopurulent discharge primarily from middle meatus and/or
  * Endoscopic signs of oedema/mucosal obstruction primarily in middle meatus and/or
  * Inflammatory mucosal changes within the ostiomeatal complex and/or sinus in the CT/CBCT scans and the changes are limited mainly into maxillary sinuses (Fokkens et al. 2012)

The patients are not recruited in the study while they are having an exacerbation of chronic rhinosinusitis or an ongoing acute rhinosinusitis. Neither are the follow-up visits carried out during these episodes but postponed later. This way it can be ensured that the preoperative evaluation and the follow-up evaluation correspond with each other.

Where this trial is running

Tampere

• Tampere University Hospital — Tampere, Finland (Recruiting)

Study contacts

• Principal investigator: Johanna Luukkanen, MD — Doctoral thesis researcher
• Study coordinator: Johanna Luukkanen

Conditions Maxillary Sinusitis; Sinusitis, Chronic; Sinusitis Recurrent; Eustachian Tube Dysfunction; Balloon sinuplasty