Allergic Rhinitis Clinical Trial
Official title:
Effectiveness of Nasal Budesonide on Control of Airway Inflammation by Determining FeNO in Children With Allergic Rhinitis.
Verified date | January 2018 |
Source | Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In clinical trials for treatment of allergic rhinitis a significant reduction of the total
symptom score compared to baseline has been demonstrated by using nasal budesonide.Previous
results in adults show that the assessment and monitoring del nasal fractional exhaled nitric
oxide (nFeNO) is useful in controlling inflammation of nasal allergic rhinitis.
Primary objective of this study is to evaluate efficacy of nasal budesonide (aqueous
solution) on the nasal inflammation marker (nFeNO).
Secondary outcomes are the evaluation of: changes in total nasal symptom score (Total Symptom
Score, T5SS), changes in cell counts in nasal lavage (LN) and the changes reported sleep
quality (Pittsburgh Sleep Quality Index, PSQI).
Status | Completed |
Enrollment | 39 |
Est. completion date | March 2014 |
Est. primary completion date | March 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 14 Years |
Eligibility |
Inclusion Criteria: - history of allergic rhinitis for at least 1 year - children aged 6 - 14 years - Total Symptom Score (T5SS) more than 6 in the last 4 days before the screening visit Exclusion Criteria: - signs of acute respiratory infection - systemic immunological and metabolic disease - major malformations of the upper airways - topical or systemic therapy with antibiotics, antihistamines and corticosteroids in the 30 days prior to the study - patient active smoker |
Country | Name | City | State |
---|---|---|---|
Italy | Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council | Palermo | Sicily |
Lead Sponsor | Collaborator |
---|---|
Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy |
Italy,
Baraldi E, Azzolin NM, Carrà S, Dario C, Marchesini L, Zacchello F. Effect of topical steroids on nasal nitric oxide production in children with perennial allergic rhinitis: a pilot study. Respir Med. 1998 Mar;92(3):558-61. — View Citation
Bellodi S, Tosca MA, Pulvirenti G, Petecchia L, Serpero L, Silvestri M, Sabatini F, Battistini E, Rossi GA. Activity of budesonide on nasal neutrophilic inflammation and obstruction in children with recurrent upper airway infections. A preliminary investi — View Citation
Meltzer EO, Munafo DA, Chung W, Gopalan G, Varghese ST. Intranasal mometasone furoate therapy for allergic rhinitis symptoms and rhinitis-disturbed sleep. Ann Allergy Asthma Immunol. 2010 Jul;105(1):65-74. doi: 10.1016/j.anai.2010.04.020. — View Citation
Meltzer EO. Clinical and antiinflammatory effects of intranasal budesonide aqueous pump spray in the treatment of perennial allergic rhinitis. Ann Allergy Asthma Immunol. 1998 Aug;81(2):128-34. — View Citation
Pedroletti C, Lundahl J, Alving K, Hedlin G. Effect of nasal steroid treatment on airway inflammation determined by exhaled nitric oxide in allergic schoolchildren with perennial rhinitis and asthma. Pediatr Allergy Immunol. 2008 May;19(3):219-26. doi: 10 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nasal nitric oxide (nFeNO) | Assessment of the influence of nasal Budesonide (aqueous solution) on nasal FeNo (nFeNO) in children with allergic rhinitis. | 21 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05080322 -
Efficacy and Safety of On-demand and Continuous Administration of Nasal Spray in the Treatment of Allergic Rhinitis
|
Phase 4 | |
Recruiting |
NCT06028490 -
A Study of IL4Rα Monoclonal Antibody in Patients With Uncontrolled Seasonal Allergic Rhinitis.
|
Phase 2 | |
Completed |
NCT04388358 -
Traditional Chinese Medicine for the Treatment of Perennial Allergic Rhinitis on Gut Microbiota and Immune-modulation
|
N/A | |
Recruiting |
NCT04202263 -
Assessment of Suppression of Cutaneous Allergic Responses and Pruritis by Topical Minocycline
|
Phase 2 | |
Completed |
NCT04078009 -
Standardising Nasal Allergen Challenge in Adult With Hay Fever
|
N/A | |
Completed |
NCT03644680 -
Changes in Adaptive Immune Responses and Effector Cell Responses Upon Nasal Allergen Exposure - a Pilot Study
|
N/A | |
Completed |
NCT04541004 -
Adolescent Mite Allergy Safety Evaluation
|
Phase 3 | |
Recruiting |
NCT05378594 -
HDM and Silver Birch NAC Standardisation
|
N/A | |
Not yet recruiting |
NCT05684380 -
Efficacy and Safety of MAZ-101 in the Treatment of Persistent Allergic Rhinitis (PER)
|
Phase 3 | |
Completed |
NCT02910401 -
Clinical Response to Rhinovirus Challenge
|
Phase 2 | |
Completed |
NCT02943720 -
ATIBAR - Efficacy and Safety of Two Doses of AllerT in Patients Allergic to Birch Pollen
|
Phase 2 | |
Not yet recruiting |
NCT01014325 -
Safety and Efficacy Study With Allergen Extracts of House Dust Mites for Specific Sublingual Immunotherapy
|
Phase 3 | |
Completed |
NCT02556801 -
Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy
|
Phase 2 | |
Completed |
NCT02352168 -
Airway Inflammation in Children With Allergic Rhinitis and Intervention
|
N/A | |
Not yet recruiting |
NCT02233426 -
Effect of Hypertonic Solutions on Allergic Rhinitis Patients
|
N/A | |
Completed |
NCT01918956 -
PURETHAL Birch RUSH Study
|
Phase 4 | |
Completed |
NCT01946035 -
Alpha-Blockers in Allergic Rhinitis (MAN 01)
|
Phase 4 | |
Completed |
NCT01682070 -
SUBLIVAC FIX Phleum Pratense DT/DRF
|
Phase 2 | |
Recruiting |
NCT01454492 -
The Relationship Between Allergic Rhinitis and Geographic Tongue
|
N/A | |
Completed |
NCT01439815 -
An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo
|
Phase 4 |