Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02409563
Other study ID # 2/2013
Secondary ID ethics committee
Status Completed
Phase Phase 4
First received February 7, 2013
Last updated January 8, 2018
Start date January 2014
Est. completion date March 2014

Study information

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

Clinical Trial Summary

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).


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Budesonide nasal spray (100 mcg bid)

Budesonide nasal spray (50 mcg bid


Locations

Country Name City State
Italy Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council Palermo Sicily

Sponsors (1)

Lead Sponsor Collaborator
Istituto di Biomedicina e Immunologia Molecolare Alberto Monroy

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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

Outcome

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
See also
  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