ATP Project (Asthma afTer Polypectomy) (ATP)

February 12, 2020 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

106

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08025
        • Lorena Soto-Retes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with persistent asthma and grade II and III bilateral sinonasal polyposisand, by voluntary decision of the otolaryngologist and the patient, who will offer alternatives treatment to the candidate patient, following the recommendations of clinical practice guidelines.

If the patient is indicated in routine clinical practice FESS-BP, will be offer to enter to the study.

If the patient is NOT indicated in routine clinical practice FESS-BP or reject intervention, will be also offer to enter to the study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Asthma with NP and require surgery
Patients receiving standardized treatment for nasal polyposis, according to the POLINA guidelines and for persistent asthma who will undergo FESS-BP.
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.
Asthma with NP and NOT require surgery
Patients receiving standardized treatment for nasal polyposis, according to the POLINA guidelines and for persistent asthma who will NOT undergo FESS-BP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breath inflammation measured by the fractional exhaled nitric oxide (FeNO)
Time Frame: 12 months
part per billion
12 months
Asthma control bases on the ACT Questionnaire (Asthma Control Test)
Time Frame: 12 month
5-25 points, on 5 is bad control and 25 is the maximun asthma control
12 month
Spirometry measure FEV1
Time Frame: 12 month
percentage
12 month
Sputum and blood test
Time Frame: 12 month
eosinophils percentage
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal, inhalated or oral steroid treatment
Time Frame: 12 months
micrograms/day
12 months
Mini questionnaire of quality of life (MiniAQLQ)
Time Frame: 12 months
1-7 points
12 months
Questionnaire of chonic rhinosinusitis (SNOT 22)
Time Frame: 12 month
0-5 points
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Collaborators

Sociedad Española de Neumología y Cirugía Torácica
Universitat Autonoma de Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 16, 2019

Study Registration Dates

First Submitted

March 25, 2015

First Submitted That Met QC Criteria

April 27, 2015

First Posted (Estimate)

April 28, 2015

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIBSP-PEN-2015-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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