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

NCT01326247 | Completed Phase 4 DMC

• 1 other identifier: studioterme
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinitis (Disorder)

Outcome Measures

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.

Study Arms (1)

0.9% NaCl solution

NO INTERVENTION

Other: thermal waters nasal irrigation

Interventions

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.

0.9% NaCl solution

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federico II University: lead
• University of Campania Luigi Vanvitelli: collaborator

Study Sites (1)

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

Ischia, Campania, Italy

Location

Related Publications (1)

• 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.

  PMID: 22230419 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Michele Miraglia del Giudice, MD

  Dipartimento di Pediatria "F.Fede" - Seconda Università di Napoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 28, 2011
• First Posted: March 30, 2011
• Study Start: April 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2009
• Last Updated: April 1, 2011

Record last verified: 2009-12

Locations

IT (1)