Allergic Rhinitis (Disorder)Phase 4NCT01326247
Effectiveness Of Therapy With A Thermal Water Nasal Aerosol In Children With Seasonal Allergic Rhinitis
A Phase 4 study testing thermal waters nasal irrigation in people with Allergic Rhinitis (Disorder), run by Federico II University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Allergic Rhinitis (Disorder)
- What is being tested?
- thermal waters nasal irrigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2009to Sep 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
UOC Pediatria e Neonatologia, ASL Na-2, PO "Anna Rizzoli"
Ischia, Campania
About this study
Official title: 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.
Read the 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.
- Conditions
- Allergic Rhinitis (Disorder)
- Being tested
- thermal waters nasal irrigation
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thermal waters nasal irrigationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 0.9% NaCl solution | No intervention | Not described Receives: Other: thermal waters nasal irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startApr 2009
- Primary completionJun 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Allergic Rhinitis (Disorder)Studies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Campania Luigi Vanvitelli
- Investigators
- Michele Miraglia del Giudice, MD, Principal investigator, Dipartimento di Pediatria "F.Fede" - Seconda Università di Napoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01326247
- Sponsor's protocol ID
- studioterme
- Status last verified
- Dec 2009
- First submitted
- 28 Mar 2011
- Last updated
- 1 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22230419
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTIVENESS OF THERAPY WITH A THERMAL WATER NASAL AEROSOL IN CHILDREN WITH SEASONAL ALLERGIC RHINITIS
- ClinicalTrials.gov ID
- NCT01326247
- Acronym / sponsor ID
- studioterme
- Conditions
- Allergic Rhinitis (Disorder)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Collaborators
- University of Campania Luigi Vanvitelli
- Study start
- Apr 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 30 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 0.9% NaCl solution | No intervention | Other: thermal waters nasal irrigation |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thermal waters nasal irrigationThe 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. | Other | 0.9% NaCl solution |
Primary outcome
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).
1 secondary outcome
exhaled nitric oxide (FeNO) by NIOX MINO analyzer COSMED, to assess airway inflammation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2011.
- Derived from this study: PubMed 22230419Miraglia 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele Miraglia del Giudice, MD principal investigator
Dipartimento di Pediatria "F.Fede" - Seconda Università di Napoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing thermal waters nasal irrigation in people with Allergic Rhinitis (Disorder), run by Federico II University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01326247, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2011.