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Intervenciones médicas para la rinosinusitis crónica en la fibrosis quística

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Referencias

Referencias de los estudios excluidos de esta revisión

Ir a:

ACTRN12613000214730 {published data only}

ACTRN12613000214730.A randomised trial of therapeutic ultrasound for chronic rhinosinusitis in adults with cystic fibrosis. www.anzctr.org.au (date submitted 20 February 2013). CENTRAL

Di Cicco 2014 {published data only}

Claut L, DiCicco M, Cariani L, Defilippi G, Costantini D, Colombo C.Tobramycin and hyaluronic acid nasal solution: beyond antimicrobial effect. Pediatric Pulmonology 2011;46 Suppl 34:322. [ABSTRACT NO.: 304] [CFGD REGISTER: CO52a] CENTRAL
Di Cicco M, Alicandro G, Claut L, Cariani L, Luca N, Defilippi G, et al.Efficacy and tolerability of a new nasal spray formulation containing hyaluronate and tobramycin in cystic fibrosis patients with bacterial rhinosinusitis. Journal of Cystic Fibrosis 2014;13(4):455-60. [CFGD REGISTER: CO52b] CENTRAL
EUCTR2007-003628-39-IT.Pilot study to evaluate the local tolerability and efficacy of a new tobramycin 3% nasal spray formulation to reduce the bacterial density of Pseudomonas aeruginosa and/or Staphylococcus aureus, in patients affected by cystic fibrosis with rhinosinusal infection - ND. www.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2007-003628-39-IT (date registered 08 April 2008). [CFGD REGISTER: CO52c] CENTRAL

IRCT20201009048976N1 {published data only}

IRCT20201009048976N1.The effect of compound honey syrup on chronic sinusitis in cystic fibrosis patients. www.who.int/trialsearch/Trial2.aspx?TrialID=IRCT20201009048976N1 (date registered 23 January 2021). [CFGD REGISTER: CO88] CENTRAL

Lee 2021 {published data only}

Lee VS, Humphreys IM, Purcell PL, Davis GE.Manuka honey versus saline sinus irrigation in the treatment of cystic fibrosis-associated chronic rhinosinusitis: a randomised pilot trial. Clinical Otolaryngology 2021;46(1):168-74. [CFGD REGISTER: CO87] CENTRAL

Mainz 2011 {published data only}

Mainz JG, Schiller I, Ritschel C, Mentzel HJ, Riethmüller J, Koitschev A, et al.Sinonasal inhalation of dornase alfa in CF: A double-blind placebo-controlled cross-over pilot trial. Auris Nasus Larynx 2011;38(2):220-7. CENTRAL [PMID: 21030168]

Mainz 2014 {published data only}

Karadag A, Catal F.Nasal saline as a placebo in chronic rhinosinusitis. Journal of Cystic Fibrosis 2014;13(5):601. [CFGD REGISTER: BD154c] CENTRAL
Mainz JG, Schien C, Schiller I, Schadlich K, Koitschev A, Koitschev C, et al.Sinonasal inhalation of dornase alfa administered by vibrating aerosol to cystic fibrosis patients: a double-blind placebo-controlled cross-over trial. Journal of Cystic Fibrosis 2014;13(4):461-70. [CFGD REGISTER: BD154b] CENTRAL [PMID: 24594542]
Mainz JG, Schiller I, Koitschev A, Koitschev C, Riethmuller J, Wiedemann B, et al.Sinonasal inhalation of dornase alfa reduces rhinosinusitis symptoms in CF. Results of a DBPC-cross-over-study. Journal of Cystic Fibrosis 2010;9 Suppl 1:S23. [ABSTRACT NO.: 88] [CFGD REGISTER: BD154a] CENTRAL

Mainz 2016 {published data only}

Mainz JG, Schaedlich K, Hentschel J, Schumacher U, Koitschev C, Koitschev A, et al.Sinonasal inhalation of isotonic vs. hypertonic saline (6.0%) in CF patients with chronic rhinosinusitis - results of a multicentre, double-blind, controlled prospective trial. Journal of Cystic Fibrosis 2015;14 Suppl 1:S95. [ABSTRACT NO.: 146] [CFGD REGISTER: CO59a] CENTRAL
Mainz JG, Schumacher U, Schadlich K, Hentschel J, Koitschev C, Koitschev A, et al.Sino nasal inhalation of isotonic versus hypertonic saline (6.0%) in CF patients with chronic rhinosinusitis - Results of a multicenter, prospective, randomized, double-blind, controlled trial. Journal of Cystic Fibrosis 2016;15(6):e57-e66. [CFGD REGISTER: CO59b] CENTRAL [PMID: 27267518]

NCT00416182 {published data only}

NCT00416182.Nasally delivered pulmozyme for sinusitis in cystic fibrosis. www.clinicaltrials.gov/show/nct00416182 (first posted 27 December 2006). CENTRAL

NCT03145051 {published data only}

NCT03145051.Efficacy of nasal irrigation with Respimer® Netiflow® vs saline among patients with cystic fibrosis and chronic rhinosinusitis. www.clinicaltrials.gov/show/NCT03145051 (first posted 09 May 2017). CENTRAL

NCT03439865 {published and unpublished data}NCT03439865

NCT03439865.Ivacaftor for acquired CFTR dysfunction in chronic rhinosinusitis. www.clinicaltrials.gov/ct2/show/NCT03439865 (first posted 20 February 2018). CENTRAL

Wagner 1999 {published data only}

Wagner JA, Messner AH, Moran ML, Daifuku R, Kouyama K, Desch JK, et al.Safety and biological efficacy of an adeno-associated virus vector-cystic fibrosis transmembrane regulator (AAV-CFTR) in the cystic fibrosis maxillary sinus. Laryngoscope 1999;109(2 Pt 1):266-74. [CFGD REGISTER: BD8b] CENTRAL
Wagner JA, Nepomuceno IB, Shah N, Messner AH, Moran ML, Norbash AM, et al.Maxillary sinusitis as a surrogate model for CF gene therapy clinical trials in patients with antrostomies. Journal of Gene Medicine 1999;1(1):13-21. [CFGD REGISTER: BD8c] CENTRAL
Wagner JA, Reynolds T, Moran ML, Moss RB, Wine JJ, Flotte TR, et al.Efficient and persistent gene transfer of AAV-CFTR in maxillary sinus [letter]. Lancet 1998;351(9117):1702-3. [CFGD REGISTER: BD8a] CENTRAL

Wagner 2002 {published data only}

Wagner JA, Messner AH, Friborg S, Reynolds T, Guggino WB, Moss RB, et al.A phase II, double-blind, randomized, placebo-controlled clinical trial of tgAAVCF in the maxillary sinus of CF patients. Pediatric Pulmonology 1998;Suppl 17:260. [CFGD REGISTER: BD9a] CENTRAL
Wagner JA, Messner AH, Moran ML, Guggino WB, Flotte TR, Wine JJ, et al.A phase II, double-blind, randomized, placebo-controlled clinical trial of tgAAVCF using maxillary sinus delivery in CF patients with antrostomies. Pediatric Pulmonology 1999;Suppl 19:223-4. [CFGD REGISTER: BD9b] CENTRAL
Wagner JA, Moran ML, Messner AH, Daifuku R, Conrad CK, Reynolds T, et al.A phase I/II study of tgAAV-CF for the treatment of chronic sinusitis in patients with cystic fibrosis. Human Gene Therapy 1998;9(6):889-909. [CFGD REGISTER: BD9d] CENTRAL
Wagner JA, Nepomuceno IB, Messner AH, Moran ML, Batson EP, Dimiceli S, et al.A phase II, double-blind, randomized, placebo-controlled clinical trial of tgAAVCF using maxillary sinus delivery in patients with cystic fibrosis with antrostomies. Human Gene Therapy 2002;13(11):1349-59. [CFGD REGISTER: BD9c] CENTRAL [PMID: 12162817]

Referencias de los estudios en curso

Ir a:

NCT02888730 {published and unpublished data}NCT02888730

NCT02888730.Tobramycin delivered by nebulized sonic aerosol for chronic rhinosinusitis treatment of cystic fibrosis patients (AVASMUC). www.clinicaltrials.gov/ct2/show/NCT02888730 (first posted 05 September 2016). CENTRAL

Referencias adicionales

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Higgins 2011b

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Holzmann D, Speich R, Kaufmann T, Laube I, Russi EW, Simmen D, et al.Effects of sinus surgery in patients with cystic fibrosis after lung transplantation: a 10-year experience. Transplantation 2004;77(1):134-6. [PMID: 14724449]

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Illing EA, Woodworth BA.Management of the upper airway in cystic fibrosis. Current Opinion in Pulmonary Medicine 2014;20(6):623-31. [PMID: 25250804]

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Jones JW, Parsons DS, Cuyler JP.The results of functional endoscopic sinus (FES) surgery on the symptoms of patients with cystic fibrosis. International Journal of Pediatric Otorhinolaryngology 1993;28(1):25-32. [PMID: 8300311]

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Kaiser J.Personalized medicine. New cystic fibrosis drug offers hope, at a price. Science 2012;335(6069):645. [PMID: 22323790]

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Kang SH, Dalcin Pde T, Piltcher OB, Migliavacca Rde O.Chronic rhinosinusitis and nasal polyposis in cystic fibrosis: update on diagnosis and treatment. Jornal Brasileiro de Pneumologia 2015;41(1):65-76. [PMID: 25750676]

Karanth 2019

Karanth TK, Karanth VKLKL, Ward BK, Woodworth BA, Karanth L.Medical interventions for chronic rhinosinusitis in cystic fibrosis. Cochrane Database of Systematic Reviews 2019, Issue 10. Art. No: CD012979. [DOI: 10.1002/14651858.CD012979.pub2]

Kim 2015

Kim RJ, Park L, Wood AJ, Yin T, Jain R, Douglas RG.Chronic rhinosinusitis and cystic fibrosis: the interaction between sinus bacteria and mucosal immunity. International Forum of Allergy & Rhinology 2015;5(5):380-5. [PMID: 25778791]

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Langton Hewer SC, Smyth AR.Antibiotic strategies for eradicating Pseudomonas aeruginosa in people with cystic fibrosis. Cochrane Database of Systematic Reviews 2017, Issue 4. Art. No: CD004197. [DOI: 10.1002/14651858.CD004197.pub5]

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Characteristics of studies

Characteristics of excluded studies [ordered by study ID]

Ir a:

Study

Reason for exclusion

ACTRN12613000214730

Intervention undertaken was not considered in our protocol.

In this trial, study group underwent therapeutic ultrasound insonation over each maxillary sinus for five minutes. This intervention has not been considered in our protocol. Hence, we excluded this trial.

Di Cicco 2014

Follow‐up period was not adequate for analysis.

In this trial, included participants were treated with nasal spray formulation consisting of a 10 mL aqueous solution of 0.2% sodium hyaluronate and 3% tobramycin sulphate for 14 days. They were assessed on the first and 14th day. The minimum period of follow‐up needed to include a trial in this review is 3 months. Hence, we excluded this trial.

IRCT20201009048976N1

Intervention undertaken was not considered in our protocol.

In this trial, participants were treated with compound honey syrup. This intervention has not been considered in our protocol. Hence, we excluded this trial.

Lee 2021

Intervention undertaken was not considered in our protocol

In this trial, the study group was treated with 10% (v/v) manuka honey (MEDIHONEY®; Derma Sciences; Princeton, NJ) . This intervention has not been considered in our protocol. Hence, we excluded this trial.

Mainz 2011

Follow‐up period was not adequate for analysis.

In this trial, included participants were treated with inhaled dornase alfa or normal saline for 28 days. They were assessed on 28th day. After a washout period of another 28 days, they were crossed over to the alternative treatment. The minimum period of follow‐up needed to include a trial in this review in 3 months. Hence, we excluded this trial.

Mainz 2014

Follow‐up period was not adequate for analysis.

In this trial, included participants were treated with inhaled dornase alfa or normal saline for 28 days. They were assessed on the 28th day. After a washout period of another 28 days, they were crossed over to the alternative treatment. The minimum period of follow‐up needed to include a trial in this review is 3 months. Hence, we excluded this trial.

Mainz 2016

Follow‐up period was not adequate for analysis.

In this trial, included participants were treated with inhaled hypertonic saline (6%) or normal saline for 28 days. They were assessed on the 28th day. After a washout period of another 28 days, they were crossed over to the alternative treatment. The minimum period of follow‐up needed to include a trial in this review is 3 months. Hence, we excluded this trial.

NCT00416182

Trial evaluated the effect of medical interventions on surgical outcomes.

In this trial, participants were randomized to receive dornase alfa or placebo via nasal inhalation one week following a nasal surgery, to assess improvement in post‐operative sinusitis symptoms.

We have planned to exclude trials evaluating effect of medical interventions on surgical outcomes. Hence, we excluded this trial.

NCT03145051

Follow‐up period was not adequate for analysis.

In this trial, included participants were treated with nasal irrigation with Respimer® mineral salts solution for 8 weeks. They were assessed at begining of trial, 4 weeks into treatment and at the end of 8 weeks. The minimum period of follow‐up needed to include a trial in this review is 3 months. Hence, we excluded this trial.

NCT03439865

Follow‐up period was not adequate for analysis.

In the protocol of this ongoing trial, participants were planned to be treated with ivacaftor along with standard of care treatment (topical nasal steroid spray and culture‐directed antibiotics) or standard of care alone for 14 days. Outcomes are planned to be assessed on day 1, day 14 and day 30. The minimum period of follow‐up needed to include a trial in this review is 3 months. Hence, we excluded this trial.

Wagner 1999

Methodology of randomisation was not acceptable as per our protocol.

Investigators preformed a prospective, randomized, phase I clinical trial by instilling adeno‐associated virus vector ‐ CF transmembrane conductance regulator (AAV‐CFTR) into a maxillary sinus with a surgically‐created antrostomy. The contralateral sinus served as a control.

According to our protocol, we planned to exclude trials randomized by the side of the nose. Hence, we excluded this trial.

Wagner 2002

Methodology of randomisation was not acceptable as per our protocol.

Investigators performed a phase II double‐blind randomized placebo‐controlled trial by instilling 100,000 replication units of targeted genetics adeno‐associated virus vector – CF (tgAAVCF) into one of the maxillary sinuses. The contralateral maxillary sinus acted as a control. According to our protocol, we planned to exclude trials randomized by the side of the nose. Hence we excluded this trial.

CF: cystic fibrosis

Characteristics of ongoing studies [ordered by study ID]

Ir a:

NCT02888730

Study name

Efficacy of Antibiotic (Tobramycin) Delivered by Nebulized Sonic Aerosol for Chronic Rhinosinusitis Treatment of Cystic Fibrosis Patients: A Multicenter Double‐blind Randomized Controlled Trial

Methods

RCT

Parallel assignment

Triple blinded

Duration: 15 days

Multicenter: 6 centers (Créteil, Marseille, Nantes, Toulouse, Clermont‐Ferrand and Nice)

Participants

Estimated enrolment: 86 participants aged 7 years or older

Inclusion criteria

  • Aged 7 years or older and followed in the participating centres; age restriction due to children aged 7 years or more because as they have a better adherence to nebulization treatment than younger children

  • Diagnosis of CF confirmed by sweat test (> 60 mmol/L) or the identification of 2 CF‐causing mutations (or both)

  • Confirmed CRS by an otolaryngologist‐head and neck surgeon by endoscopic examination: bilateral mucopurulent secretions at middle meatus present longer than 12 weeks with or without nasal polyps

  • Positive bacteria susceptibility to tobramycin in samples from middle meatus; susceptibility of bacteria to tobramycin confirmed

  • Pulmonary examination before enrolment

Exclusion criteria

  • Oral antibiotic therapy 1 month before enrolment

  • Enrolment in another protocol using antibiotic treatments

  • Ongoing aerosolized tobramycin for endobronchial infection to avoid an overlap between treatment for lung and treatment for sinusitis

  • Abnormal auditory acuity (increase of 20 dB hearing loss in auditory acuity)

  • Hypersensitivity or allergy to aminoglycoside antibiotics

  • FEV less than 25% or FVC of 40% or more of the value predicted for height

  • Transplant recipient or currently on a transplant list

  • Using nasal oxygen or under non‐invasive ventilation methods

  • Women who are pregnant or breastfeeding

Interventions

Treatment arm

1 ampoule tobramycin (5 mL containing 300 mg of tobramycin and 11.25 mg of sodium chloride) nebulized nasally 2x per day (morning and evening with a maximum of 12 hours but not less than 6 hours between the 2 doses) each sonic nebulization lasting approximately 15 minutes; dosage will not be adjusted to body weight. Active intervention is manufactured by the "Pharmacie à Usage Interne" of the Henri Mondor Hospital prepared with Base Tobramycin and excipients in accordance with TOBI's composition

Control arm

1 ampoule placebo (5 mL containing sodium chloride 0.9%) nebulized nasally 2x per day (morning and evening with a maximum of 12 hours but not less than 6 hours between the 2 doses) each sonic nebulization lasting approximately 15 minutes; dosage will not be adjusted to body weight. Placebo is manufactured by the "Pharmacie à Usage Interne" of the Henri Mondor Hospital so that it has the same colour (light yellow transparent) as tobramycin

Outcomes

Primary outcome

  • Density of bacteria (in CFU/g log10) in sinus ostia of middle meatus samples at day 15

Secondary outcomes

  • Density of bacteria (in CFU/g log10) in sinus ostia of middle meatus samples at day 30 and 90

  • Minimum inhibitor concentration of sputum bacteria to antibiotics at day 15, 30 and 90

  • Minimum inhibitor concentration of sputum bacteria to tobramycin at day 90

  • FVC in both groups at day 0 and day 30

  • FEV in 1 second in both groups at day 0 and day 30

  • Nasal obstruction at day 90 compared to baseline at day 0, 15, 30 and 90

  • Rhinorrhea compared to baseline at day 0, 15, 30 and 90

  • Mucopurulent secretions compared to baseline at day 0, 15, 30 and 90

  • Facial pain compared to baseline at day 0, 15, 30 and 90

  • Dysosmia compared to baseline at day 0, 15, 30 and 90

  • Nasal endoscopic scores compared to baseline in both groups at day 0, 15, 30 and 90

  • Score of the SM5 quality of life questionnaire in both groups at day 0, 15, 30 and 90

  • Score of the SNOT‐20 quality of life questionnaire in both groups at day 0, 15, 30 and 90

  • Hearing perceptual thresholds of the intensity (in dB hearing loss) and frequency (Hz) of sound waves at day 0 and day 30

Starting date

February 2017

Contact information

Virginie ESCABASSE, MD

Tel: 1 45 17 55 97 ext 33

[email protected]

Notes

CF: cystic fibrosis
CFU: colony forming units
CRS: chronic rhinosinusitis
CT: computer tomography
FEV: forced expiratory volume
FVC: forced vital capacity
RCT: randomized controlled trial
SNOT: sino‐nasal outcomes test

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