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Completed

NCT Number: NCT01326247

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

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.

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Key information

Conditions

Allergic Rhinitis (Disorder) Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Ischia, Campania, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

thermal waters nasal irrigation

Other

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 outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Federico II University

Other

Collaborators

  • University of Campania Luigi Vanvitelli

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 30, 2011
Registry last updated
Apr 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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