Trial | NCT02409563  Report issue

Title

Nasal Budesonide Efficacy on Nasal FeNO in Children With Allergic Rhinitis
Effectiveness of Nasal Budesonide on Control of Airway Inflammation by Determining FeNO in Children With Allergic Rhinitis.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    budesonide ...

  • Study Participants

    39
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).
Study Started
Jan 31
2014
Primary Completion
Mar 31
2014
Study Completion
Mar 31
2014
Last Update
Jan 09
2018

Drug Budesonide nasal spray (100 mcg bid)

Drug Budesonide nasal spray (50 mcg bid

Budesonide nasal (100 mcg bid) Experimental

The study will be randomized, controlled parallel group. After 1 week of phase baseline screening (Visit 1), patients will be randomized (1:4) with the assignment of a code (B-200_da 01 to 08, B-100_ 01 to 31) (day 0, Visit 2) in 2 groups: N1 (n = 8) = Budesonide nasal spray 100 mcg, 2 v / d; Patients return to control after the 1st week (day 7, Visit 3), after the 2nd week (day 14, Visit 4) and one week after the end of the treatment period (day 21, Visit 5). It will give a tolerance of ± 3 days for the timing of planned visits. In the phase of follow-up, (3 days after the last dose of drug) will be recorded the occurrence of adverse effects (Adverse Event, EA)

Budesonide nasal (50 mcg bid) Experimental

The study will be randomized, controlled parallel group. After 1 week of phase baseline screening (Visit 1), patients will be randomized (1:4) with the assignment of a code (B-200_da 01 to 08, B-100_ 01 to 31) (day 0, Visit 2) in 2 groups: ; N2 (n = 31) = Budesonide nasal spray 50 mcg, 2 v / d. Patients return to control after the 1st week (day 7, Visit 3), after the 2nd week (day 14, Visit 4) and one week after the end of the treatment period (day 21, Visit 5). It will give a tolerance of ± 3 days for the timing of planned visits. In the phase of follow-up, (3 days after the last dose of drug) will be recorded the occurrence of adverse effects (Adverse Event, EA)

Criteria 

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
No Results Posted