SinusitisPhase 4RAISeNCT03011632

Response of the Airway in Sinusitis and Asthma

A Phase 4 study testing Mometasone Nasal in people with Sinusitis and Asthma, run by Medical University of Lodz at 1 site in Poland.

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

Who is it for?: Ages 4 to 8 years
Conditions the study is for: Sinusitis, Asthma
What is being tested?: Mometasone Nasal
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 150 participants
Where: 1 sitePoland
Study dates: Jan 2017to Aug 2019
Phase: Phase 4
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 4 to 8 years
All sexes
No healthy volunteers
Child

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Poland1 site

Department of Internal Medicine, Asthma and Allergy, Barlicki University Hospital, Medical University of Lodz, Lodz, Poland
Lodz, 90-153

Other trials in Poland

About this study

Official title: The Role of Nonspecific Immune Response of the Airway Mucosa in Children With Chronic Rhinosinusitis and Asthma

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.

Read the detailed description

Persistence of CRS and asthma require multiple interconnected feedback and feed-forward circuits between ILCs and epithelial cells. It seems that type 2 ILCs (ILC2) are the most important accelerators of type II immune response that prepare cytokine microenvironment for Th2 cells chronic activation. What decide on ILC2 accumulation - this is an urgent question. The aim of the proposed project is to examine the role of the innate immune response of airways in children suffering from chronic rhinosinusitis and asthma.

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 CRS (fulfilling the EPOS criteria) and asthma (fulfilling the 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: SN-5 and cACT questionnaires, skin prick test, spirometry, measurement of NO in exhaled breath, taste perception test, eosinophil morphology assessment, ratio: glucose concentration in nasal secretion/serum glucose level, concentration of specific immunoglobulin E, total IgG and IgA, the proportion of ILC2 cells and regulatory 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) PCR examination for the detection of the presence of viral and bacterial genetic material, ii) measurement of the expression of the various mRNA types, iii) measurement of the expression of mRNA for the Epithelial-Mesenchymal Transition (EMT) genes and iv) percentage of ILC 1, 2 and 3 cells and regulatory cells.

Conditions: Sinusitis, Asthma
Being tested: Mometasone Nasal, placebo mometasone
Medical subject headings: Sinusitis, Asthma

What participants receive

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

Mometasone NasalDrug
Also called NasometinTM, Sandoz
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
placebo mometasoneDrug
Also called placebo
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,

Study groups in NCT03011632
Study group	Role	What they receive
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, Receives: 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, Receives: Drug: placebo mometasone

What is being measured

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

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
Measured: 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)
Measured: 12 months

Secondary outcomes (5)

Spirometry
Respiratory function tests will be performed according to the American Thoracic Society (ATS) standards. The best result of three spirometric maneuvers will be selected for the analysis of obstructive disorders and the level of disease severity according to the standards of the Polish Society of Lung Diseases. The analysis will include FEV1% (A/N% - the percent of the measured to predicted value).
Measured: 12 months
Nasal fraction of exhaled nitric oxide (nFeNO) Measurements
Measurements of nasal fraction of exhaled nitric oxide (nFeNO) will be performed using an electrochemical analyzer (ExpAir) according to the manufacturer's instructions. The detection limit ranged from 1 ppb to 6000 ppb.
Measured: 12 months
Glucose concentration
Glucose concentration in serum and in nasal secretions will be assessed using glucose oxidase sticks (Roche, Lewes, East Sussex, U.K.). Nasal glucose concentration will analyzed in the context of blood glucose level using following ratio: nasal glucose level/blood glucose level.
Measured: 12 months
Immunophenotyping
Mucosa - The nasal mucosa sample will be gently processed (mechanical dissociation, mild enzyme digestion) to produce a single cell suspension. It will be further fixed and stained with specific cocktail of fluorescent dye-stained antibody and then cell identification will be performed by flow cytometry. The relative count of all cell subsets will be determined. All procedures will be performed in buffers containing brefeldin and/or monesin to prevent dislocation of proteins of interest.
Measured: 12 months
quantitative polymerase chain reaction (qPCR)
Total RNA will be isolated from mucosa samples and then reverse-transcribed with e.g. Thermo Scientific Maxima Reverse Transcriptase. qPCR reaction will be performed using house-designed primer sets. Relative expression of genes of interest (involved in innate response) will be analyzed against selected house-keeping gene transcripts.
Manufacturer recommended procedure will be used to quantify Human Epithelial to Mesenchymal Transition gene panel and Multiplex Real-Time PCR for pathogen genes
Measured: 12 months

Timeline

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

Jan 2017Aug 2019

First posted5 Jan 2017 (estimated)
Study startJan 2017
Primary completionAug 2019
Study completionAug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for SinusitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03011632
Sponsor's protocol ID: RNN/153/16/KE
Acronym: RAISe
Status last verified: Aug 2019
First submitted: 2 Jan 2017
Last updated: 13 Aug 2019
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Dobrakowski L, Kalisiak M, Majak J, Otocka-Kmiecik A, Majak P. Predicting the course of chronic rhinosinusitis in young children-5-year prospective study. Pediatr Allergy Immunol. 2026 Jul;37(7):e70416. doi: 10.1111/pai.70416.
PubMed 42418237
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.
PubMed 36848113
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.
PubMed 34510485
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.
PubMed 33222307

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Biologics in Chronic Rhinosinusitis With Nasal Polyposis
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A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
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Active, not recruitingPhase 3
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
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Not yet recruiting
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RecruitingPhase 4
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All Sinusitis trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Role of Nonspecific Immune Response of the Airway Mucosa in Children With Chronic Rhinosinusitis and Asthma
ClinicalTrials.gov ID: NCT03011632
Acronym / sponsor ID: RAISe / RNN/153/16/KE
Conditions: Sinusitis, Asthma
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: Medical University of LodzUniversity, hospital or other
Study start: Jan 2017 (actual)
Primary completion: Aug 2019 (actual)
Study completion: Aug 2019 (actual)
First posted: 5 Jan 2017 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 CRS (fulfilling the EPOS criteria) and asthma (fulfilling the 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: SN-5 and cACT questionnaires, skin prick test, spirometry, measurement of NO in exhaled breath, taste perception test, eosinophil morphology assessment, ratio: glucose concentration in nasal secretion/serum glucose level, concentration of specific immunoglobulin E, total IgG and IgA, the proportion of ILC2 cells and regulatory 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) PCR examination for the detection of the presence of viral and bacterial genetic material, ii) measurement of the expression of the various mRNA types, iii) measurement of the expression of mRNA for the Epithelial-Mesenchymal Transition (EMT) genes and iv) percentage of ILC 1, 2 and 3 cells and regulatory cells.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
mometasone nasal	Experimental	Drug: Mometasone Nasala 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,
placebo mometasone	Placebo comparator	Drug: placebo mometasonea 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,

Who may qualify

Ages: 4 to 8 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mometasone NasalAlso: NasometinTM, Sandoza 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 mometasoneAlso: placeboa 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,	Drug	placebo mometasone

Primary outcome

Asthma Control Test for children (cACT™)
Time frame: 12 months
Childhood Asthma Control Test (cACT™), will be used, which has been recommended by the Global Initiative for Asthma (GINA) Report
SN-5
Time frame: 12 months
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)

5 secondary outcomes

Spirometry
Time frame: 12 months
Nasal fraction of exhaled nitric oxide (nFeNO) Measurements
Time frame: 12 months
Glucose concentration
Time frame: 12 months
Immunophenotyping
Time frame: 12 months
quantitative polymerase chain reaction (qPCR)
Time frame: 12 months

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
Derived from this study: PubMed 42418237Dobrakowski L, Kalisiak M, Majak J, Otocka-Kmiecik A, Majak P. Predicting the course of chronic rhinosinusitis in young children-5-year prospective study. Pediatr Allergy Immunol. 2026 Jul;37(7):e70416. doi: 10.1111/pai.70416.
Derived from this study: PubMed 36848113Latek 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.
Derived from this study: PubMed 34510485Molinska 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.
Derived from this study: PubMed 33222307Majak 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pawel Majak, MD, PhD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Mometasone Nasal in people with Sinusitis and Asthma, run by Medical University of Lodz at 1 site in Poland.

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 3 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 13 Aug 2019. 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 Poland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Asthma Control Test for children (cACT™) (time frame: 12 months). The study lists 2 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 NCT03011632, which also lists 4 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 13 Aug 2019.