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Effectiveness Of Therapy With A Thermal Water Nasal Aerosol In Children With Seasonal Allergic Rhinitis

Primary Purpose

Allergic Rhinitis (Disorder)

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
thermal waters nasal irrigation
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis (Disorder)

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of moderate to severe allergic rhinitis.
  • Children aged 6-14 year sensitized to parietaria.
  • History of spring time symptoms.
  • History of mild intermittent asthma.

Exclusion Criteria:

  • Use of LABA, antihistamines, intranasal, bronchial or systemic corticosteroids, cromolyn sodium and leukotriene modifiers in the last 6 weeks.
  • The presence of respiratory tract infection, persistent asthma, respiratory tract abnormalities or diseases.

Sites / Locations

  • UOC Pediatria e Neonatologia, ASL Na-2, PO "Anna Rizzoli"

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

0.9% NaCl solution

Arm Description

Outcomes

Primary Outcome Measures

The Primary Outcome was to measure the differences in nasal symptoms score (TSS) about groups after three months of therapy. Data were compared by the Mann-Whitney test.
At the time of recruitment, the parents of the children were instructed to fill a specific diary-card (TSS) at home, to assess rhinitis symptoms and possible drug use during all 3 months of treatment. The parameters considered in the TSS were: nasal obstruction, sneezing, nasal discharge and itching. These symptoms were scored: 0 = symptom absent, 1 = mild (symptoms present but not annoying), 2 = moderate (frequent and offensive symptoms but do not interfere with sleep or normal activities) 3 = severe (symptoms that interfere with sleep or normal activities).

Secondary Outcome Measures

exhaled nitric oxide (FeNO) by NIOX MINO analyzer COSMED, to assess airway inflammation.
It's well known that allergic rhinitis is often associated with asthma. Allergic rhinitis and asthma are expressions of respiratory mucosal eosinophilic inflammation. Before the treatment (T0), at the end of the treatment (T1) and again 2 weeks after the end of the treatment (T2), all the children have performed spirometry and exhaled nitric oxide (FeNO) (NIOX MINO analyzer COSMED), to assess their airway inflammation.

Full Information

First Posted
March 28, 2011
Last Updated
March 31, 2011
Sponsor
Federico II University
Collaborators
University of Campania "Luigi Vanvitelli"
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1. Study Identification

Unique Protocol Identification Number
NCT01326247
Brief Title
Effectiveness Of Therapy With A Thermal Water Nasal Aerosol In Children With Seasonal Allergic Rhinitis
Official Title
EFFECTIVENESS OF THERAPY WITH A THERMAL WATER NASAL AEROSOL IN CHILDREN WITH SEASONAL ALLERGIC RHINITIS
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federico II University
Collaborators
University of Campania "Luigi Vanvitelli"

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study was to evaluate the effects of Ischia thermal waters nasal irrigation on allergic rhinitis and airway inflammation during the period of natural exposure to parietaria pollen in children with allergic rhinitis and intermittent asthma.
Detailed Description
The study was conducted on the island of Ischia - Naples from April to June 2009, during the natural exposure period to parietaria pollen. The treatment started just before the pollen season, when all the children were asymptomatic, not treated with any drug and not affected by respiratory tract and systemic diseases. All the children were randomly divided into two homogeneous groups by sex and age. The first group has practiced crenotherapy with "hyper-mineral chloride sodium water" aerosol by nasal adapter for 15 days per month, for three consecutive months, at thermal spa services of Lacco Ameno, while the control group was treated, in the same period, daily, by a micronized nasal douche with 0.9% NaCl (isotonic) solution. Before the treatment (T0), at the end of the treatment (T1) and again 2 weeks after the end of the treatment (T2), all the children have performed spirometry (Pony FX Cosmed), and exhaled nitric oxide (FeNO) (NIOX MINO analyzer COSMED), to assess their airway inflammation. At the time of recruitment, the parents of the children were instructed to fill a specific diary-card (TSS) at home, to assess rhinitis symptoms and possible drug use during all 3 months of treatment. The parameters considered in the TSS were: nasal obstruction, sneezing, nasal discharge and itching. These symptoms were scored: 0 = symptom absent, 1 = mild (symptoms present but not annoying), 2 = moderate (frequent and offensive symptoms but do not interfere with sleep or normal activities) 3 = severe (symptoms that interfere with sleep or normal activities). Every two weeks, at the end of each cycle of therapy the children underwent a general clinical control with nasal endoscopy, spirometry and monitoring the completion of diary cards and the possible use of drugs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis (Disorder)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.9% NaCl solution
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
thermal waters nasal irrigation
Intervention Description
The first group (group 1) has practiced crenotherapy with "hyper-mineral chloride sodium water" aerosol by nasal adapter for 15 days per month, for three consecutive months, at thermal spa services of Lacco Ameno, while the control group (group 2) was treated, in the same period, daily, by a micronized nasal douche with 0.9% NaCl (isotonic) solution.
Primary Outcome Measure Information:
Title
The Primary Outcome was to measure the differences in nasal symptoms score (TSS) about groups after three months of therapy. Data were compared by the Mann-Whitney test.
Description
At the time of recruitment, the parents of the children were instructed to fill a specific diary-card (TSS) at home, to assess rhinitis symptoms and possible drug use during all 3 months of treatment. The parameters considered in the TSS were: nasal obstruction, sneezing, nasal discharge and itching. These symptoms were scored: 0 = symptom absent, 1 = mild (symptoms present but not annoying), 2 = moderate (frequent and offensive symptoms but do not interfere with sleep or normal activities) 3 = severe (symptoms that interfere with sleep or normal activities).
Secondary Outcome Measure Information:
Title
exhaled nitric oxide (FeNO) by NIOX MINO analyzer COSMED, to assess airway inflammation.
Description
It's well known that allergic rhinitis is often associated with asthma. Allergic rhinitis and asthma are expressions of respiratory mucosal eosinophilic inflammation. Before the treatment (T0), at the end of the treatment (T1) and again 2 weeks after the end of the treatment (T2), all the children have performed spirometry and exhaled nitric oxide (FeNO) (NIOX MINO analyzer COSMED), to assess their airway inflammation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of moderate to severe allergic rhinitis. Children aged 6-14 year sensitized to parietaria. History of spring time symptoms. History of mild intermittent asthma. Exclusion Criteria: Use of LABA, antihistamines, intranasal, bronchial or systemic corticosteroids, cromolyn sodium and leukotriene modifiers in the last 6 weeks. The presence of respiratory tract infection, persistent asthma, respiratory tract abnormalities or diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Miraglia del Giudice, MD
Organizational Affiliation
Dipartimento di Pediatria "F.Fede" - Seconda Università di Napoli
Official's Role
Principal Investigator
Facility Information:
Facility Name
UOC Pediatria e Neonatologia, ASL Na-2, PO "Anna Rizzoli"
City
Ischia
State/Province
Campania
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22230419
Citation
Miraglia Del Giudice M, Decimo F, Maiello N, Leonardi S, Parisi G, Golluccio M, Capasso M, Balestrieri U, Rocco A, Perrone L, Ciprandi G. Effectiveness of Ischia thermal water nasal aerosol in children with seasonal allergic rhinitis: a randomized and controlled study. Int J Immunopathol Pharmacol. 2011 Oct-Dec;24(4):1103-9. doi: 10.1177/039463201102400431.
Results Reference
derived

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Effectiveness Of Therapy With A Thermal Water Nasal Aerosol In Children With Seasonal Allergic Rhinitis

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