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New treatment option for Maxillary Sinusitis
Official title Balloon Sinuplasty Efficiency in Maxillary Rhinosinusitis.
ClinicalTrials.gov ID: NCT04645511
What this study is testing
- What it's testing
- This study is a prospective, randomized, placebo-controlled, double-blinded clinical study. The balloon sinuplasty treatment is compared to placebo effect in chronic or recurrent maxillary sinusitis.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 69
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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 in chronic rhinosinusitis group:
- Maxillar 0-2
- Anterior Ethmoid 0-2
- Posterior Ethmoid 0-1
- Sphenoid 0-1
- Frontal 0-1
- Ostiomeatal complex 0 or 2
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tampere, Finland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampere, Finland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.