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

This study has been completed.
Sponsor:
Collaborator:
Second University of Naples
Information provided by:
Federico II University
ClinicalTrials.gov Identifier:
NCT01326247
First received: March 28, 2011
Last updated: March 31, 2011
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Allergic Rhinitis (Disorder)
Other: thermal waters nasal irrigation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: EFFECTIVENESS OF THERAPY WITH A THERMAL WATER NASAL AEROSOL IN CHILDREN WITH SEASONAL ALLERGIC RHINITIS

Resource links provided by NLM:


Further study details as provided by Federico II University:

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. [ Designated as safety issue: No ]
    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).

  • 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. [ Designated as safety issue: No ]
    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. [ Designated as safety issue: Yes ]
    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.


Enrollment: 40
Study Start Date: April 2009
Study Completion Date: September 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 0.9% NaCl solution Other: thermal waters nasal irrigation
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.

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.

  Eligibility

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326247

Locations
Italy
UOC Pediatria e Neonatologia, ASL Na-2, PO "Anna Rizzoli"
Ischia, Campania, Italy
Sponsors and Collaborators
Federico II University
Second University of Naples
Investigators
Principal Investigator: Michele Miraglia del Giudice, MD Dipartimento di Pediatria "F.Fede" - Seconda Università di Napoli
  More Information

No publications provided by Federico II University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michele Miraglia del Giudice, MD, Dipartimento di Pediatria "F.Fede" - Seconda Università di Napoli
ClinicalTrials.gov Identifier: NCT01326247     History of Changes
Other Study ID Numbers: studioterme
Study First Received: March 28, 2011
Last Updated: March 31, 2011
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on July 23, 2014