Rhinitis, AllergicNCT05301647
Mometasone Furoate Nasal Spray in Italian Children
An observational study of Rhinitis, Allergic and Nasal Allergy, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
Trial summary
Objective Seasonal allergic rhinitis (SAR) is a common disease in childhood and characterized by type 2 inflammation, bothersome symptoms, and impaired quality of life (QoL). Intranasal corticosteroids are effective medications in managing SAR patients. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Rhinitis, Allergic, Nasal Allergy, Allergy Pollen
- What is being tested?
- Nasal cytology, The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) and Total symptom score (TSS)
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 20 Jun 2019to 20 Oct 2021
- 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 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Globally, 80 children were enrolled, but 76 (40 males and 36 females, mean age 11.4 + 3.3 years) completed the study. Children were randomly (ratio 1:1) subdivided into two groups: the active group treated with MFNS (Mometasone group) and the control group treated with isotonic saline.
Who may be able to join
- Inclusion criteria were: age range 4-12 years, SAR diagnosis, Total Symptoms Score (TSS) ≥ 6, and written informed consent of both parents or legal guardians.
Who cannot join
- Exclusion criteria were: perennial AR, rhinitis due to other causes, concomitant acute or chronic rhinosinusitis, nasal polyps, asthma comorbidity, current use of topical or systemic corticosteroids, antihistamines, antileukotrienes, inadequate washout of them, nasal anatomic defect, respiratory infections in the last two weeks, participation in other clinical studies in the previous month, documented hypersensitivity to the study product or its excipients, and trip planned outside of the study area.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mometasone Furoate Nasal Spray in Italian Children With Seasonal Allergic Rhinitis: a Comprehensive Assessment
Objective Seasonal allergic rhinitis (SAR) is a common disease in childhood and characterized by type 2 inflammation, bothersome symptoms, and impaired quality of life (QoL). Intranasal corticosteroids are effective medications in managing SAR patients. In addition, mometasone furoate nasal spray (MFNS) is a well-known therapeutic option. However, the literature provided no data about its effects in European children with SAR. Thus this study addressed this unmet need.
Read the detailed description
Objective Seasonal allergic rhinitis (SAR) is a common disease in childhood and characterized by type 2 inflammation, bothersome symptoms, and impaired quality of life (QoL). Intranasal corticosteroids are effective medications in managing SAR patients. In addition, mometasone furoate nasal spray (MFNS) is a well-known therapeutic option. However, the literature provided no data about its effects in European children with SAR. Thus this study addressed this unmet need.
Methods MFNS was compared to isotonic saline. Both treatments were prescribed one spray per nostril, twice a day, per 3 weeks. Nasal cytology, total symptom score (TSS), visual analogic scale concerning the parental perception of symptom severity, and the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) were assessed at baseline, after 7 and 21 days, and one month after discontinuation.
- Conditions
- Rhinitis, Allergic, Nasal Allergy, Allergy Pollen, Nasal, Cytology, Mometasone Allergy, Quality of Life
- Being tested
- Nasal cytology, The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), Total symptom score (TSS), Visual analogic scale (VAS)
- Keywords
- seasonal allergic rhinitis, mometasone furoate nasal spray, nasal cytology, type 2 inflammation, symptoms, quality of life
- Medical subject headings
- Rhinitis, Allergic, Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal cytologyDiagnostic test
The cytological technique involves the following moments: sampling, processing, which includes fixation, staining and microscopic observation. Cytological sampling consists in the collection of superficial cells of the nasal mucosa with the help of a sterile swab or a small curette (scraping) in disposable plastic material (Rhino-probe).
The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)Other
The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) consists of 23 questions in 5 domains (nasal symptoms, ocular symptoms, practical issues, limitation of activities, other symptoms) that are answered on a 7-point scale (0-6), where 0 represents the absence of problems and 6 the greatest symptom distress. Children will complete the questionnaire together with a parent at baseline and during the study. A Total Score was calculated as the mean of the 5 domains.
Total symptom score (TSS)Other
Total symptom score was the sum of 3 domains: i) nasal symptoms (TNSS) included itching, sneezing, rhinorrhea, nasal congestion; ii) ocular symptoms (TOSS): itching, hyperemia of the conjunctiva, tearing; and iii) throat symptoms (TTSS): itching, coughing. With the help of their parents, patients scored symptoms severity on a 4-point scale: 0 = absent or irrelevant, 1 = mild, 2 = moderate, 3 = severe. Total symptom score was assessed at 12 hours (TTS 12h) and two weeks (TTS 2W) before the visits. TSS represents the doctor's point of view of symptom severity
Visual analogic scale (VAS)Other
A visual analogic scale (VAS) measured the parental perception of symptom severity (0=no symptom; 10=very severe symptoms).
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Not described Receives: Diagnostic Test: Nasal cytology; Other: The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ); Other: Total symptom score (TSS); Other: Visual analogic scale (VAS) | |
| Control Group | Not described Receives: Diagnostic Test: Nasal cytology; Other: The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ); Other: Total symptom score (TSS); Other: Visual analogic scale (VAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in eosinophils, mast cells and neutrophil infiltrate by nasal cytology after the treatment
The primary endpoint of this study was the change in eosinophilic mast cells and neutrophil infiltrate, assessed by nasal cytology
Measured: 2019-2021
Secondary outcomes (2)
Assesment of symptoms during the study
The secondary objective was the nasal symptom severity during the study assessed by total symptom score (TSS)
Measured: 2019-2021
Assesment of quality of life changes during the study
The secondary objective was the changes of quality of life during the study assessed by the validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)
Measured: 2019-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start20 Jun 2019
- Primary completion20 Sep 2021
- Study completion20 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Rhinitis, AllergicStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Michele Miraglia del Giudice, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301647
- Sponsor's protocol ID
- VANVCIT1
- Status last verified
- Mar 2022
- First submitted
- 1 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wise SK, Lin SY, Toskala E, Orlandi RR, Akdis CA, Alt JA, Azar A, Baroody FM, Bachert C, Canonica GW, Chacko T, Cingi C, Ciprandi G, Corey J, Cox LS, Creticos PS, Custovic A, Damask C, DeConde A, DelGaudio JM, Ebert CS, Eloy JA, Flanagan CE, Fokkens WJ, Franzese C, Gosepath J, Halderman A, Hamilton RG, Hoffman HJ, Hohlfeld JM, Houser SM, Hwang PH, Incorvaia C, Jarvis D, Khalid AN, Kilpelainen M, Kingdom TT, Krouse H, Larenas-Linnemann D, Laury AM, Lee SE, Levy JM, Luong AU, Marple BF, McCoul ED, McMains KC, Melen E, Mims JW, Moscato G, Mullol J, Nelson HS, Patadia M, Pawankar R, Pfaar O, Platt MP, Reisacher W, Rondon C, Rudmik L, Ryan M, Sastre J, Schlosser RJ, Settipane RA, Sharma HP, Sheikh A, Smith TL, Tantilipikorn P, Tversky JR, Veling MC, Wang Y, Westman M, Wickman M, Zacharek M. International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis. Int Forum Allergy Rhinol. 2018 Feb;8(2):108-352. doi: 10.1002/alr.22073.
PubMed 29438602Wen T, Rothenberg ME. Cell-by-cell deciphering of T cells in allergic inflammation. J Allergy Clin Immunol. 2019 Nov;144(5):1143-1148. doi: 10.1016/j.jaci.2019.10.001.
PubMed 31703761Han X, Krempski JW, Nadeau K. Advances and novel developments in mechanisms of allergic inflammation. Allergy. 2020 Dec;75(12):3100-3111. doi: 10.1111/all.14632. Epub 2020 Nov 4.
PubMed 33068299Ciprandi G, Klersy C, Cirillo I, Marseglia GL. Quality of life in allergic rhinitis: relationship with clinical, immunological, and functional aspects. Clin Exp Allergy. 2007 Oct;37(10):1528-35. doi: 10.1111/j.1365-2222.2007.02809.x.
PubMed 17883732Ciprandi G, Cirillo I, Vizzaccaro A, Milanese M, Tosca MA. Nasal obstruction in patients with seasonal allergic rhinitis: relationships between allergic inflammation and nasal airflow. Int Arch Allergy Immunol. 2004 May;134(1):34-40. doi: 10.1159/000077531. Epub 2004 Mar 25.
PubMed 15051938Cirillo I, Marseglia G, Klersy C, Ciprandi G. Allergic patients have more numerous and prolonged respiratory infections than nonallergic subjects. Allergy. 2007 Sep;62(9):1087-90. doi: 10.1111/j.1398-9995.2007.01401.x. Epub 2007 Jun 18.
PubMed 17578494Juel-Berg N, Darling P, Bolvig J, Foss-Skiftesvik MH, Halken S, Winther L, Hansen KS, Askjaer N, Heegaard S, Madsen AR, Opstrup MS. Intranasal corticosteroids compared with oral antihistamines in allergic rhinitis: A systematic review and meta-analysis. Am J Rhinol Allergy. 2017 Jan 9;31(1):19-28. doi: 10.2500/ajra.2016.30.4397.
PubMed 28234147Baldwin CM, Scott LJ. Mometasone furoate: a review of its intranasal use in allergic rhinitis. Drugs. 2008;68(12):1723-39. doi: 10.2165/00003495-200868120-00009.
PubMed 18681494Ciprandi G, Varricchio A. The relevance of the Mometasone furoate nasal spray in clinical practice. J Biol Regul Homeost Agents. 2018 Jul-Aug;32(4):1051-1054.
PubMed 30043593Meltzer EO, Baena-Cagnani CE, Gates D, Teper A. Relieving nasal congestion in children with seasonal and perennial allergic rhinitis: efficacy and safety studies of mometasone furoate nasal spray. World Allergy Organ J. 2013 Mar 4;6(1):5. doi: 10.1186/1939-4551-6-5.
PubMed 23663488Meltzer EO, Shekar T, Teper AA. Mometasone furoate nasal spray for moderate-to-severe nasal congestion in subjects with seasonal allergic rhinitis. Allergy Asthma Proc. 2011 Mar-Apr;32(2):159-67. doi: 10.2500/aap.2011.32.3424.
PubMed 21439168Ciprandi G, Tosca MA, Passalacqua G, Canonica GW. Intranasal mometasone furoate reduces late-phase inflammation after allergen challenge. Ann Allergy Asthma Immunol. 2001 Apr;86(4):433-8. doi: 10.1016/S1081-1206(10)62491-X.
PubMed 11345288Hoyte FCL, Nelson HS. Recent advances in allergic rhinitis. F1000Res. 2018 Aug 23;7:F1000 Faculty Rev-1333. doi: 10.12688/f1000research.15367.1. eCollection 2018.
PubMed 30210782Karatzas K, Katsifarakis N, Riga M, Werchan B, Werchan M, Berger U, Pfaar O, Bergmann KC. New European Academy of Allergy and Clinical Immunology definition on pollen season mirrors symptom load for grass and birch pollen-induced allergic rhinitis. Allergy. 2018 Sep;73(9):1851-1859. doi: 10.1111/all.13487. Epub 2018 Jun 17.
PubMed 29791010Gelardi M, Fiorella ML, Russo C, Fiorella R, Ciprandi G. Role of nasal cytology. Int J Immunopathol Pharmacol. 2010 Jan-Mar;23(1 Suppl):45-9.
PubMed 20152080
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mometasone Furoate Nasal Spray in Italian Children With Seasonal Allergic Rhinitis: a Comprehensive Assessment
- ClinicalTrials.gov ID
- NCT05301647
- Acronym / sponsor ID
- VANVCIT1
- Conditions
- Rhinitis, Allergic, Nasal Allergy, Allergy Pollen, Nasal, Cytology, Mometasone Allergy, Quality of Life
- Keywords
- seasonal allergic rhinitis, mometasone furoate nasal spray, nasal cytology, type 2 inflammation, symptoms, quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- 20 Jun 2019 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 31 Mar 2022 (actual)
- 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.
Objective Seasonal allergic rhinitis (SAR) is a common disease in childhood and characterized by type 2 inflammation, bothersome symptoms, and impaired quality of life (QoL). Intranasal corticosteroids are effective medications in managing SAR patients. In addition, mometasone furoate nasal spray (MFNS) is a well-known therapeutic option. However, the literature provided no data about its effects in European children with SAR. Thus this study addressed this unmet need.
Detailed description
Objective Seasonal allergic rhinitis (SAR) is a common disease in childhood and characterized by type 2 inflammation, bothersome symptoms, and impaired quality of life (QoL). Intranasal corticosteroids are effective medications in managing SAR patients. In addition, mometasone furoate nasal spray (MFNS) is a well-known therapeutic option. However, the literature provided no data about its effects in European children with SAR. Thus this study addressed this unmet need.
Methods MFNS was compared to isotonic saline. Both treatments were prescribed one spray per nostril, twice a day, per 3 weeks. Nasal cytology, total symptom score (TSS), visual analogic scale concerning the parental perception of symptom severity, and the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) were assessed at baseline, after 7 and 21 days, and one month after discontinuation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Group | – | Diagnostic Test: Nasal cytology, Other: The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), Other: Total symptom score (TSS), Other: Visual analogic scale (VAS) |
| Control Group | – | Diagnostic Test: Nasal cytology, Other: The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), Other: Total symptom score (TSS), Other: Visual analogic scale (VAS) |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Globally, 80 children were enrolled, but 76 (40 males and 36 females, mean age 11.4 + 3.3 years) completed the study. Children were randomly (ratio 1:1) subdivided into two groups: the active group treated with MFNS (Mometasone group) and the control group treated with isotonic saline.
Key inclusion criteria (1 listed)
- Inclusion criteria were: age range 4-12 years, SAR diagnosis, Total Symptoms Score (TSS) ≥ 6, and written informed consent of both parents or legal guardians.
Key exclusion criteria (1 listed)
- Exclusion criteria were: perennial AR, rhinitis due to other causes, concomitant acute or chronic rhinosinusitis, nasal polyps, asthma comorbidity, current use of topical or systemic corticosteroids, antihistamines, antileukotrienes, inadequate washout of them, nasal anatomic defect, respiratory infections in the last two weeks, participation in other clinical studies in the previous month, documented hypersensitivity to the study product or its excipients, and trip planned outside of the study area.
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 |
|---|---|---|
| Nasal cytologyThe cytological technique involves the following moments: sampling, processing, which includes fixation, staining and microscopic observation. Cytological sampling consists in the collection of superficial cells of the nasal mucosa with the help of a sterile swab or a small curette (scraping) in disposable plastic material (Rhino-probe). | Diagnostic test | Active Group, Control Group |
| The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)The validated Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) consists of 23 questions in 5 domains (nasal symptoms, ocular symptoms, practical issues, limitation of activities, other symptoms) that are answered on a 7-point scale (0-6), where 0 represents the absence of problems and 6 the greatest symptom distress. Children will complete the questionnaire together with a parent at baseline and during the study. A Total Score was calculated as the mean of the 5 domains. | Other | Active Group, Control Group |
| Total symptom score (TSS)Total symptom score was the sum of 3 domains: i) nasal symptoms (TNSS) included itching, sneezing, rhinorrhea, nasal congestion; ii) ocular symptoms (TOSS): itching, hyperemia of the conjunctiva, tearing; and iii) throat symptoms (TTSS): itching, coughing. With the help of their parents, patients scored symptoms severity on a 4-point scale: 0 = absent or irrelevant, 1 = mild, 2 = moderate, 3 = severe. Total symptom score was assessed at 12 hours (TTS 12h) and two weeks (TTS 2W) before the visits. TSS represents the doctor's point of view of symptom severity | Other | Active Group, Control Group |
| Visual analogic scale (VAS)A visual analogic scale (VAS) measured the parental perception of symptom severity (0=no symptom; 10=very severe symptoms). | Other | Active Group, Control Group |
Primary outcome
Change in eosinophils, mast cells and neutrophil infiltrate by nasal cytology after the treatment
Time frame: 2019-2021
The primary endpoint of this study was the change in eosinophilic mast cells and neutrophil infiltrate, assessed by nasal cytology
2 secondary outcomes
Assesment of symptoms during the study
Time frame: 2019-2021
Assesment of quality of life changes during the study
Time frame: 2019-2021
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 31 Mar 2022.
- Results publication: PubMed 29438602Wise SK, Lin SY, Toskala E, Orlandi RR, Akdis CA, Alt JA, Azar A, Baroody FM, Bachert C, Canonica GW, Chacko T, Cingi C, Ciprandi G, Corey J, Cox LS, Creticos PS, Custovic A, Damask C, DeConde A, DelGaudio JM, Ebert CS, Eloy JA, Flanagan CE, Fokkens WJ, Franzese C, Gosepath J, Halderman A, Hamilton RG, Hoffman HJ, Hohlfeld JM, Houser SM, Hwang PH, Incorvaia C, Jarvis D, Khalid AN, Kilpelainen M, Kingdom TT, Krouse H, Larenas-Linnemann D, Laury AM, Lee SE, Levy JM, Luong AU, Marple BF, McCoul ED, McMains KC, Melen E, Mims JW, Moscato G, Mullol J, Nelson HS, Patadia M, Pawankar R, Pfaar O, Platt MP, Reisacher W, Rondon C, Rudmik L, Ryan M, Sastre J, Schlosser RJ, Settipane RA, Sharma HP, Sheikh A, Smith TL, Tantilipikorn P, Tversky JR, Veling MC, Wang Y, Westman M, Wickman M, Zacharek M. International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis. Int Forum Allergy Rhinol. 2018 Feb;8(2):108-352. doi: 10.1002/alr.22073.
- Results publication: PubMed 31703761Wen T, Rothenberg ME. Cell-by-cell deciphering of T cells in allergic inflammation. J Allergy Clin Immunol. 2019 Nov;144(5):1143-1148. doi: 10.1016/j.jaci.2019.10.001.
- Results publication: PubMed 33068299Han X, Krempski JW, Nadeau K. Advances and novel developments in mechanisms of allergic inflammation. Allergy. 2020 Dec;75(12):3100-3111. doi: 10.1111/all.14632. Epub 2020 Nov 4.
- Results publication: PubMed 17883732Ciprandi G, Klersy C, Cirillo I, Marseglia GL. Quality of life in allergic rhinitis: relationship with clinical, immunological, and functional aspects. Clin Exp Allergy. 2007 Oct;37(10):1528-35. doi: 10.1111/j.1365-2222.2007.02809.x.
- Results publication: PubMed 15051938Ciprandi G, Cirillo I, Vizzaccaro A, Milanese M, Tosca MA. Nasal obstruction in patients with seasonal allergic rhinitis: relationships between allergic inflammation and nasal airflow. Int Arch Allergy Immunol. 2004 May;134(1):34-40. doi: 10.1159/000077531. Epub 2004 Mar 25.
- Results publication: PubMed 17578494Cirillo I, Marseglia G, Klersy C, Ciprandi G. Allergic patients have more numerous and prolonged respiratory infections than nonallergic subjects. Allergy. 2007 Sep;62(9):1087-90. doi: 10.1111/j.1398-9995.2007.01401.x. Epub 2007 Jun 18.
- Results publication: PubMed 28234147Juel-Berg N, Darling P, Bolvig J, Foss-Skiftesvik MH, Halken S, Winther L, Hansen KS, Askjaer N, Heegaard S, Madsen AR, Opstrup MS. Intranasal corticosteroids compared with oral antihistamines in allergic rhinitis: A systematic review and meta-analysis. Am J Rhinol Allergy. 2017 Jan 9;31(1):19-28. doi: 10.2500/ajra.2016.30.4397.
- Results publication: PubMed 18681494Baldwin CM, Scott LJ. Mometasone furoate: a review of its intranasal use in allergic rhinitis. Drugs. 2008;68(12):1723-39. doi: 10.2165/00003495-200868120-00009.
- Results publication: PubMed 30043593Ciprandi G, Varricchio A. The relevance of the Mometasone furoate nasal spray in clinical practice. J Biol Regul Homeost Agents. 2018 Jul-Aug;32(4):1051-1054.
- Results publication: PubMed 23663488Meltzer EO, Baena-Cagnani CE, Gates D, Teper A. Relieving nasal congestion in children with seasonal and perennial allergic rhinitis: efficacy and safety studies of mometasone furoate nasal spray. World Allergy Organ J. 2013 Mar 4;6(1):5. doi: 10.1186/1939-4551-6-5.
- Results publication: PubMed 21439168Meltzer EO, Shekar T, Teper AA. Mometasone furoate nasal spray for moderate-to-severe nasal congestion in subjects with seasonal allergic rhinitis. Allergy Asthma Proc. 2011 Mar-Apr;32(2):159-67. doi: 10.2500/aap.2011.32.3424.
- Results publication: PubMed 11345288Ciprandi G, Tosca MA, Passalacqua G, Canonica GW. Intranasal mometasone furoate reduces late-phase inflammation after allergen challenge. Ann Allergy Asthma Immunol. 2001 Apr;86(4):433-8. doi: 10.1016/S1081-1206(10)62491-X.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinitis, Allergic and Nasal Allergy, run by University of Campania Luigi Vanvitelli at 1 site in Italy.
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 1 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 31 Mar 2022. 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 Italy. 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?
Change in eosinophils, mast cells and neutrophil infiltrate by nasal cytology after the treatment (time frame: 2019-2021). 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 NCT05301647, which also lists 18 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 31 Mar 2022.