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AsthmaATPNCT02427503

ATP Project (Asthma afTer Polypectomy)

An observational study of Asthma and Nasal Polyps, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Asthma, Nasal Polyps
What is being tested?
Asthma with NP and require surgery
Type of treatment
Surgery or procedure
How many people
106 participants
Where
1 siteSpain
Study dates
Jul 2016to 16 Dec 2019
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Lorena Soto-Retes

    Barcelona, 08025

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Conditions
Asthma, Nasal Polyps
Being tested
Asthma with NP and require surgery
Keywords
asthma, sinonasal polyposis, eosinophilic bronchial inflammation, endoscopic sinus surgery
Medical subject headings
Asthma, Nasal Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Asthma with NP and require surgeryProcedure or 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.

Study groups in NCT02427503
Study groupRoleWhat they receive
Asthma with NP and require surgeryPatients receiving standardized treatment for nasal polyposis, according to the POLINA guidelines and for persistent asthma who will undergo FESS-BP.
Receives: Procedure: Asthma with NP and require surgery
Asthma with NP and NOT require surgeryPatients receiving standardized treatment for nasal polyposis, according to the POLINA guidelines and for persistent asthma who will NOT undergo FESS-BP.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Breath inflammation measured by the fractional exhaled nitric oxide (FeNO)

    part per billion

    Measured: 12 months

  2. 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

    Measured: 12 month

  3. Spirometry measure FEV1

    percentage

    Measured: 12 month

  4. Sputum and blood test

    eosinophils percentage

    Measured: 12 month

Secondary outcomes (3)

  1. Nasal, inhalated or oral steroid treatment

    micrograms/day

    Measured: 12 months

  2. Mini questionnaire of quality of life (MiniAQLQ)

    1-7 points

    Measured: 12 months

  3. Questionnaire of chonic rhinosinusitis (SNOT 22)

    0-5 points

    Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2015 (estimated)
  2. Study startJul 2016
  3. Primary completionDec 2018
  4. Study completion16 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
106 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02427503
Sponsor's protocol ID
IIBSP-PEN-2015-11
Acronym
ATP
Status last verified
Feb 2020
First submitted
25 Mar 2015
Last updated
17 Feb 2020
Results posted
No
Data monitoring committee
No

Publications

  • Johansson L, Akerlund A, Holmberg K, Melen I, Bende M. Prevalence of nasal polyps in adults: the Skovde population-based study. Ann Otol Rhinol Laryngol. 2003 Jul;112(7):625-9. doi: 10.1177/000348940311200709.

    PubMed 12903683

  • 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. doi: 10.1111/j.1398-9995.2005.00688.x.

    PubMed 15647046

  • Perez De Llano LA, Gonzalez FC, Anon OC, Perea MP, Caruncho MV, Villar AB; Proyecto Camaron (Control del Asma Mediante el Analisis Regular del Oxido Nitrico). [Relationship between comorbidity and asthma control]. Arch Bronconeumol. 2010 Oct;46(10):508-13. doi: 10.1016/j.arbres.2010.05.008. Epub 2010 Jul 17. Spanish.

    PubMed 20638762

  • Grossman J. One airway, one disease. Chest. 1997 Feb;111(2 Suppl):11S-16S. doi: 10.1378/chest.111.2_supplement.11s.

    PubMed 9042022

  • 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. doi: 10.1067/mai.2001.113046.

    PubMed 11240947

  • Togias A. Rhinitis and asthma: evidence for respiratory system integration. J Allergy Clin Immunol. 2003 Jun;111(6):1171-83; quiz 1184. doi: 10.1067/mai.2003.1592.

    PubMed 12789212

  • Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, Zuberbier T, Baena-Cagnani CE, Canonica GW, van Weel C, Agache I, Ait-Khaled N, Bachert C, Blaiss MS, Bonini S, Boulet LP, Bousquet PJ, Camargos P, Carlsen KH, Chen Y, Custovic A, Dahl R, Demoly P, Douagui H, Durham SR, van Wijk RG, Kalayci O, Kaliner MA, Kim YY, Kowalski ML, Kuna P, Le LT, Lemiere C, Li J, Lockey RF, Mavale-Manuel S, Meltzer EO, Mohammad Y, Mullol J, Naclerio R, O'Hehir RE, Ohta K, Ouedraogo S, Palkonen S, Papadopoulos N, Passalacqua G, Pawankar R, Popov TA, Rabe KF, Rosado-Pinto J, Scadding GK, Simons FE, Toskala E, Valovirta E, van Cauwenberge P, Wang DY, Wickman M, Yawn BP, Yorgancioglu A, Yusuf OM, Zar H, Annesi-Maesano I, Bateman ED, Ben Kheder A, Boakye DA, Bouchard J, Burney P, Busse WW, Chan-Yeung M, Chavannes NH, Chuchalin A, Dolen WK, Emuzyte R, Grouse L, Humbert M, Jackson C, Johnston SL, Keith PK, Kemp JP, Klossek JM, Larenas-Linnemann D, Lipworth B, Malo JL, Marshall GD, Naspitz C, Nekam K, Niggemann B, Nizankowska-Mogilnicka E, Okamoto Y, Orru MP, Potter P, Price D, Stoloff SW, Vandenplas O, Viegi G, Williams D; World Health Organization; GA(2)LEN; AllerGen. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy. 2008 Apr;63 Suppl 86:8-160. doi: 10.1111/j.1398-9995.2007.01620.x. No abstract available.

    PubMed 18331513

  • Alobid I, Anton E, Armengot M, Chao J, Colas C, del Cuvillo A, Davila I, Dordal MT, Escobar C, Fernandez-Parra B, Gras-Cabrerizo JR, Ibanez MD, Lluch M, Mateu V, Montoro J, Gili JR, Mullol J, Navarro AM, Pumarola F, Rondon C, Sanchez-Hernandez MC, Sarandeses A, Soler R, Valero AL; Rhinoconjunctivitis Committee; Spanish Society of Allergy and Clinical Immunology; Rhinology and Allergy Commission; Spanish Society of Otorhinolaryngology. SEAIC-SEORL. Consensus Document on Nasal Polyposis. POLINA Project. J Investig Allergol Clin Immunol. 2011;21 Suppl 1:1-58. No abstract available.

    PubMed 21714471

  • 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 B, Thomas M, Toskala E, Voegels R, Wang de Y, Wormald PJ. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology. 2012 Mar;50(1):1-12. doi: 10.4193/Rhino12.000.

    PubMed 22469599

  • 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. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014 Feb;43(2):343-73. doi: 10.1183/09031936.00202013. Epub 2013 Dec 12.

    PubMed 24337046

  • Braunstahl GJ, Fokkens W. Nasal involvement in allergic asthma. Allergy. 2003 Dec;58(12):1235-43. doi: 10.1046/j.0105-4538.2003.00354.x.

    PubMed 14616096

  • 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 1.

    PubMed 23818462

  • 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. doi: 10.1111/j.1365-2273.1995.tb00007.x.

    PubMed 7788929

  • 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 15;171(8):912-30. doi: 10.1164/rccm.200406-710ST. No abstract available.

    PubMed 15817806

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma and Nasal Polyps, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breath inflammation measured by the fractional exhaled nitric oxide (FeNO) (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02427503, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.

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ATP Project (Asthma afTer Polypectomy) (NCT02427503) | AzTrials