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NCT Number: NCT02784262

Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Rhinosinusitis With Nasal Polyposis

Chronic rhinosinusitis (CRS) with nasal polyps is a particularly challenging form of chronic rhinosinusitis in several ways. Patients have significantly more severe symptom burden and worse quality of life than patients with chronic rhinosinusitis without nasal polyps. Many patients return to the health care providers with persistent symptoms after repeated medical and surgical treatment. Patients have usually tried several different types of treatments, ranging from less invasive procedures to extensive surgical treatment. The surgical treatment is often repeated several times. The most common surgical treatment is functional endoscopic sinus surgery, another established procedure is Vidian neurectomy.

The main object of this pilot study is to investigate the safety of onabotulinumtoxin A towards the sphenopalatine ganglion (SPG) in CRS patients with nasal polyps. Efficacy data will also be collected to provide indication on whether future placebo-controlled studies should be performed.

Onabotulinumtoxin A inhibits the secretion of acetylcholine, blocking the parasympathetic reflex cascade in the SPG. As a result, the investigators expect less mucosal swelling, secretion and nasal polyps. The duration of such a blockade is believed to last for 3-9 months and will not lead to damage of the nerve.

This study opens up for improved treatment with less complications.

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Key information

Conditions

Chronic Disease Bites and Stings Chemically-Induced Disorders Disease Attributes Infections Nasal Polyposis Nasal Polyps Nose Diseases Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Poisoning Polyps Respiratory Tract Diseases Respiratory Tract Infections Rhinitis Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St Olavs Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • written informed consent
  • chronic rhinosinusitis with nose polyps (CRSwNP) according to European position paper on rhinosinusitis and nasal polyps (EPOS) criteria
  • no satisfactory effect of medicinal or surgical treatment

Exclusion criteria

  • systemic or local disease or condition that may result in a higher risk for complications
  • psychiatric disorder that is indicates against the treatment
  • pregnancy, breastfeeding, fertile female not using contraception
  • abuse of drugs, narcotics or alcohol
  • hypersensitivity against marcain, lidocain, xylocain, or adrenalin, and similar drugs
  • anatomical conditions that hinder injection
  • known sensitivity for botulinum toxin type A or for adjuvant substances
  • treatment with drugs that interact with botulinum toxin type A:
  • suspicion of polyps caused by an allergy
  • suspicion of Samters triade

Treatment and study plan

botox injection Multiguide

Drug

botox injection under CT/MR navigation and with the navigation tool MultiGuide

Other names: Botulinum toxin type A

Primary outcomes

  1. adverse events

    Time frame: from day 1 to 7 post surgery

    Registration of all adverse events sorted by probable relation to botox or surgery. Data collected from symptom diary, in addition to an open question at consultation and put into the Case Report Form (CRF) by physician or nurse.

Secondary outcomes

  1. change in symptom index on a visual analog scale nasal obstruction/running nose

    Time frame: 3 months

  2. change in sinonasal quality of life assessed with the sino-nasal outcome test 22 (SNOT-22)

    Time frame: 3 months

  3. change in nose-sinus related quality of life assessed with a visual analog scale (VAS)

    Time frame: 3 months

  4. change in the geometrics of the nose assessed by acoustic rhinometry

    Time frame: 3 months

  5. change in air flow in the nose measured by peak nasal inspiratory flow (PNIF)

    Time frame: 3 months

  6. change in polyp mass assessed by magnetic resonance imaging (MRI)

    Time frame: 3 months

  7. change in polyp mass assessed by computer tomography (CT)

    Time frame: 3 months

  8. change in quality of life expressed by Patients' Global Impression of Change (PGIC)

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 27, 2016
Registry last updated
Nov 5, 2021

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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