ATP Project (Asthma afTer Polypectomy)

Asthma Clinical Trial

— ATP  

Official title:

Sinonasal Functional Impact of Endoscopic Surgery for Bilateral Polyposis on Bronchial Inflammation, Control and Lung Function in Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02427503
• Other study ID #: IIBSP-PEN-2015-11
• Status: Completed
• Start date: July 2016
• Est. completion date: December 16, 2019

Study information

• Verified date: February 2020
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Inflammation of the nasal and bronchial mucosa characterizing rhinitis and asthma are probably manifestations of the same disease. Multiple functional observations, pathogenic and clinical support that assertion. It is noteworthy that most asthma patients, who underwent a nasal endoscopic polypectomy, improve your asthma after surgery. This improvement would be related to the administration of oral steroids that these patients usually receive after surgery, or the disappearance of nasal discomfort caused by nasal polyps to improve ventilation. But this does not explain why this improvement, in some cases lasting for months after the operation, and without receiving oral steroids. It is speculated that severe nasal inflammation due to nasal polyps stimulate the bone marrow to produce more eosinophils, an increased supply of blood eosinophils, and consequently, a major bronchial eosinophilic inflammation, aggravating asthma. However, it is noteworthy that studies have evaluated the clinical impact in asthma after endoscopic nasal polypectomy, are scarce or performed on a small number of cases, the results are inconsistent and do not allow categorically whether or not such positive association. And more importantly, none of them included measurements of airway inflammation and hypothesized relationship between bronchial eosinophilic inflammation and nasal polyposis, aclarar.La remains finding that provides nasal endoscopic polypectomy objective improvement of severe asthma it could be a future therapeutic option to consider in patients with asthma and rhinosinusal polyposis.

Description:

Sinonasal polyposis (SP) is a chronic inflammatory disease of the lining of the nasal passages and sinuses, with a prevalence of approximately 2-3% of the general population. The prevalence of asthma in patients diagnosed with SP is much greater than that of the general population and can reach half of the cases and indicate a more severe phenotype and worse control in asthmatic patients without SP. It is possible that the pathophysiologic mechanisms underlying the development of SP and concomitant asthma are the same and both processes can be considered the same disease.

Recommendations of major clinical practice guidelines for the treatment of SP include administration of intranasal topical steroids at high doses, and in subjects who do not respond to this treatment or are more severe, administering a course of systemic steroids orally for 10-14 days or surgical intervention including polypectomy and removal of the diseased mucosa endoscopically, known as functional endoscopic sinus surgery (FESS).

In this context, it is noteworthy that most asthma patients, who underwent functional endoscopic sinus surgery for bilateral polyposis (FESS-BP) stated it dramatically improved their asthma after surgery. This improvement could be related to the effect of oral steroids these patients often receive after surgery, or the disappearance of nasal discomfort caused by nasal polyps as ventilation improves after the intervention. However, these reasons do not sufficiently explain the fact that this improvement, in some cases extends for months after surgery, when patients are no longer receiving oral steroids.

It has been speculated that severe nasal inflammation which involves the presence of nasal polyps would constantly stimulate the bone marrow, causing on the one hand increased production of eosinophils and the other an increase in adhesiveness, and thus, an important eosinophilic bronchial inflammation. This is in line with a usual clinical observation according to which patients with asthma and sinonasal polyposis, often suffer more severe asthma; and severe sinus inflammation is one of the aggravating factors recognized in severe uncontrolled asthma.

However, studies that have assessed the clinical impact in asthma after FESS-BP, are only a few or have been performed on a small number of cases. Consequently, the results are inconsistent and do not allow to categorically establish whether this positive association exists or not. Most importantly, however, none of them included measurements of bronchial inflammation in the study variables, so that the hypothesis of the possible relationship between eosinophilic bronchial inflammation and nasal polyposis remains without having been tested.

Moreover, the finding that the FESS-BP provides an objective improvement of asthma, could be a future therapeutic option to consider in patients with severe asthma and sinonasal polyposis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: December 16, 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients of both sexes aged = 18 and younger than 70 years diagnosed with persistent asthma (according to GEMA4.0 criteria) (18) and grade II and III bilateral sinonasal polyposis of Lildholdlt (9,19), which, as indicated in routine clinical practice established by an otolaryngologist, will undergo FESS.

Exclusion Criteria:

• Intermittent asthma;

• exacerbation of asthma that required treatment with parenteral steroids one month prior to visit 1;

• concomitance of other chronic respiratory diseases (bronchiectasis, fibrosis, etc.);

• other disabling severe comorbidities in the opinion of the investigators;

• previous noninflammatory sinonasal pathology;

• corticosteroid-dependent patients or managed with other immunomodulatory treatments.

• Patients with a history of previous nasal surgery.

Related Conditions & MeSH terms

• Asthma
• Nasal Polyps

Intervention

Procedure:
• Asthma with NP and require surgery
To evaluate the effect on asthma of functional endoscopic sinus surgery of bilateral sinonasal polyposis in patients diagnosed with persistent asthma and grade II or III sinonasal polyposis.

Locations

Country	Name	City	State
Spain	Lorena Soto-Retes	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Sociedad Española de Neumología y Cirugía Torácica, Universitat Autonoma de Barcelona

Country where clinical trial is conducted

Spain, 

References & Publications (14)

Alobid I, Antón E, Armengot M, Chao J, Colás C, del Cuvillo A, Dávila I, Dordal MT, Escobar C, Fernández-Parra B, Gras-Cabrerizo JR, Ibáñez MD, Lluch M, Matéu V, Montoro J, Gili JR, Mullol J, Navarro AM, Pumarola F, Rondón C, Sánchez-Hernández MC, Sarande — View Citation

American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr — View Citation

Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, Zuberbier T, Baena-Cagnani CE, Canonica GW, van Weel C, Agache I, Aït-Khaled N, Bachert C, Blaiss MS, Bonini S, Boulet LP, Bousquet PJ, Camargos P, Carlsen KH, Chen Y, Custovic A, Dahl R, D — View Citation

Braunstahl GJ, Fokkens W. Nasal involvement in allergic asthma. Allergy. 2003 Dec;58(12):1235-43. Review. — View Citation

Braunstahl GJ, Overbeek SE, Kleinjan A, Prins JB, Hoogsteden HC, Fokkens WJ. Nasal allergen provocation induces adhesion molecule expression and tissue eosinophilia in upper and lower airways. J Allergy Clin Immunol. 2001 Mar;107(3):469-76. — View Citation

Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, Adcock IM, Bateman ED, Bel EH, Bleecker ER, Boulet LP, Brightling C, Chanez P, Dahlen SE, Djukanovic R, Frey U, Gaga M, Gibson P, Hamid Q, Jajour NN, Mauad T, Sorkness RL, Teague WG. Internationa — View Citation

Fokkens WJ, Lund VJ, Mullol J, Bachert C, Alobid I, Baroody F, Cohen N, Cervin A, Douglas R, Gevaert P, Georgalas C, Goossens H, Harvey R, Hellings P, Hopkins C, Jones N, Joos G, Kalogjera L, Kern B, Kowalski M, Price D, Riechelmann H, Schlosser R, Senior — View Citation

Grossman J. One airway, one disease. Chest. 1997 Feb;111(2 Suppl):11S-16S. Review. — View Citation

Johansson L, Akerlund A, Holmberg K, Melén I, Bende M. Prevalence of nasal polyps in adults: the Skövde population-based study. Ann Otol Rhinol Laryngol. 2003 Jul;112(7):625-9. — View Citation

Klossek JM, Neukirch F, Pribil C, Jankowski R, Serrano E, Chanal I, El Hasnaoui A. Prevalence of nasal polyposis in France: a cross-sectional, case-control study. Allergy. 2005 Feb;60(2):233-7. — View Citation

Lildholdt T, Rundcrantz H, Lindqvist N. Efficacy of topical corticosteroid powder for nasal polyps: a double-blind, placebo-controlled study of budesonide. Clin Otolaryngol Allied Sci. 1995 Feb;20(1):26-30. — View Citation

Pérez De Llano LA, González FC, Añón OC, Perea MP, Caruncho MV, Villar AB; Proyecto Camaron (Control del Asma Mediante el Análisis Regular del Óxido Nítrico). [Relationship between comorbidity and asthma control]. Arch Bronconeumol. 2010 Oct;46(10):508-13 — View Citation

Togias A. Rhinitis and asthma: evidence for respiratory system integration. J Allergy Clin Immunol. 2003 Jun;111(6):1171-83; quiz 1184. Review. — View Citation

Vashishta R, Soler ZM, Nguyen SA, Schlosser RJ. A systematic review and meta-analysis of asthma outcomes following endoscopic sinus surgery for chronic rhinosinusitis. Int Forum Allergy Rhinol. 2013 Oct;3(10):788-94. doi: 10.1002/alr.21182. Epub 2013 Jul — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breath inflammation measured by the fractional exhaled nitric oxide (FeNO)	part per billion	12 months
Primary	Asthma control bases on the ACT Questionnaire (Asthma Control Test)	5-25 points, on 5 is bad control and 25 is the maximun asthma control	12 month
Primary	Spirometry measure FEV1	percentage	12 month
Primary	Sputum and blood test	eosinophils percentage	12 month
Secondary	Nasal, inhalated or oral steroid treatment	micrograms/day	12 months
Secondary	Mini questionnaire of quality of life (MiniAQLQ)	1-7 points	12 months
Secondary	Questionnaire of chonic rhinosinusitis (SNOT 22)	0-5 points	12 month

External Links

•   Guía Española para el Manejo del Asma (GEMA) 4.0