Response of the Airway in Sinusitis and Asthma

NCT03011632 | Completed Phase 4

• 1 other identifier: RNN/153/16/KE
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The project is intended to be realised in two phases. In the first stage, a case control study will be performed. In the second phase, double-blind, placebo controlled study will be conducted. In the first phase 3 groups of children will be compare: i) a group of children suffering from chronic rhinosinusitis (CRS) (fulfilling the European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS) criteria) and asthma (fulfilling the Asthma Predictive Index (API) criteria) (CRS+/asthma+, n=90), ii) a group of children suffering from CRS (fulfilling the EPOS criteria) but without asthma symptoms (negative API criteria) (CRS+/asthma-, n=30) and iii) a group of children without symptoms of CRS (negative EPOS criteria) and without asthma symptoms (negative API criteria) (CRS-/asthma-, n=30). In the second phase the effect of intranasal glucocorticosteroids will be assessed. The following research methods will be used: CRS-symptom score questionnaire (SN-5) and Childhood Asthma Control Test (cACT) questionnaires, skin prick test, spirometry, measurement of nitric oxide NO in exhaled breath (FeNO), taste perception test, eosinophil morphology assessment, ratio: glucose concentration in nasal secretion/serum glucose level, concentration of specific immunoglobulin (Ig) E, total immunoglobulin G (IgG) and immunoglobulin A (IgA), the proportion of innate lymphoid cells (ILC) and regulatory lymphocytes cells in the peripheral blood. Endoscopic examination of the upper airways will be performed and samples of the mucosa will be taken. The mucosal examination will be as follows: i) polymerase chain reaction (PCR) examination for the detection of the presence of viral and bacterial genetic material, ii) measurement of the expression of the various messenger ribonucleic acid (mRNA), iii) measurement of the expression of mRNA for the Epithelial-Mesenchymal Transition (EMT) genes and iv) percentage of ILCs.

Conditions

Sinusitis; Asthma

Outcome Measures

Primary Outcomes (2)

• Asthma Control Test for children (cACT™)

  Childhood Asthma Control Test (cACT™), will be used, which has been recommended by the Global Initiative for Asthma (GINA) Report

  12 months

• SN-5

  validated questionnaire for the assessment for quality of life in children with CRS (5 symptom-cluster items covering the domains of sinus infection, nasal obstruction, allergy symptoms, emotional distress, and activity limitations)

  12 months

Secondary Outcomes (5)

• Spirometry

  12 months

• Nasal fraction of exhaled nitric oxide (nFeNO) Measurements

  12 months

• Glucose concentration

  12 months

• Immunophenotyping

  12 months

• quantitative polymerase chain reaction (qPCR)

  12 months

Study Arms (2)

mometasone nasal

EXPERIMENTAL

a group of children who will receive a nasal mometasone in an atomiser for three months (one application, once per day) and supplemental 3ml 0.9% sodium chloride (NaCl) solution in a nasal nebuliser once a day for 3 months,

Drug: Mometasone Nasal

placebo mometasone

PLACEBO COMPARATOR

a group of children without immunoglobulin E (IgE) - dependent hypersensitivity who will receive nasal mometasone placebo in an atomiser for three months (one application, once per day) and supplemental 3ml 0.9% NaCl solution in a nasal nebuliser once a day for 3 months,

Drug: placebo mometasone

Interventions

Mometasone Nasal DRUG

a group of children who will receive a nasal mometasone in an atomiser for three months (one application, once per day) and supplemental 3ml 0.9% Sodium chloride (NaCl) solution in a nasal nebuliser once a day for 3 months

Also known as: NasometinTM, Sandoz

mometasone nasal

placebo mometasone DRUG

a group of children without IgE-dependent hypersensitivity who will receive nasal mometasone placebo in an atomiser for three months (one application, once per day) and supplemental 3ml 0.9% NaCl solution in a nasal nebuliser once a day for 3 months,

Also known as: placebo

placebo mometasone

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• a group of children (n=90) suffering from CRS (fulfilling the EPOS criteria, European Position Paper on Rhinosinusitis and Nasal Polyps) and asthma (fulfilling the API criteria, Asthma Predictive Index), including a 30-person subgroup diagnosed with clinically significant IgE-dependent hypersensitivity (accordance between symptoms and current exposure to sensitizing allergen),
• a group of children (n=30) suffering from CRS (fulfilling the EPOS criteria) but without asthma symptoms (negative API criteria), including a 15-person subgroup diagnosed with clinically significant IgE-dependent hypersensitivity (accordance between symptoms and current exposure to sensitizing allergen),
• a group of children (n=30) without symptoms of CRS (negative EPOS criteria) and without asthma symptoms (negative API criteria).

You may not qualify if:

• food allergy with symptoms affecting the respiratory tract
• contraindication to nasal endoscopy or contraindication to nasal mucosa biopsy
• hypertrophy of the third tonsil exceeding 60% of the nasopharynx (the criterion of obstruction being an indication for adenoidectomy). In these patients, the anatomical nasal obstruction may be the single cause of chronic inflammation in the airways, and hence verification of the hypotheses is impossible
• confirmed immunodeficiency
• exacerbation of asthma requiring systemic administration of glucocorticosteroids
• obesity, exposure to tobacco smoke
• other chronic illnesses and clinical conditions, which in the opinion of the researcher may influence the evaluation and the course of the study.

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Department of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland

Lodz, 90-153, Poland

Location

Related Publications (3)

• Latek M, Lacwik P, Molinska K, Blauz A, Lach J, Rychlik B, Strapagiel D, Majak J, Molinska J, Czech D, Seweryn M, Kuna P, Palczynski C, Majak P. Effect of an Intranasal Corticosteroid on Quality of Life and Local Microbiome in Young Children With Chronic Rhinosinusitis: A Randomized Clinical Trial. JAMA Pediatr. 2023 Apr 1;177(4):345-352. doi: 10.1001/jamapediatrics.2022.6172.

  PMID: 36848113 DERIVED

• Molinska K, Latek M, Rychlik B, Lach J, Strapagiel D, Majak J, Blazowski L, Jerzynska J, Kuna P, Majak P. House dust mite sensitization and frequent antibiotic courses may suppress remission of rhinosinusitis and asthma symptoms in young children. Allergy. 2022 Jan;77(1):301-304. doi: 10.1111/all.15085. Epub 2021 Sep 17. No abstract available.

  PMID: 34510485 DERIVED

• Majak P, Molinska K, Latek M, Rychlik B, Wachulec M, Blauz A, Budniok A, Gruchala M, Lach J, Sobalska-Kwapis M, Baranowska M, Krolikowska K, Strapagiel D, Majak J, Czech D, Palczynski C, Kuna P. Upper-airway dysbiosis related to frequent sweets consumption increases the risk of asthma in children with chronic rhinosinusitis. Pediatr Allergy Immunol. 2021 Apr;32(3):489-500. doi: 10.1111/pai.13417. Epub 2020 Dec 18.

  PMID: 33222307 DERIVED

MeSH Terms

Conditions

Sinusitis; Asthma

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Pawel Majak, MD, PhD

  Department of Internal Medicine, Asthma and Alergology, Barlicki Hospital,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 2, 2017
• First Posted: January 5, 2017
• Study Start: January 1, 2017
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: August 13, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)