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Efficacy of Aerosal® in the Treatment of Sub-Obstructive Adenotonsillar Hypertrophy and Related Diseases

NCT ID: NCT01574885

Last Updated: 2012-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-04-30

Brief Summary

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The purpose of this study is to evaluate the efficacy of Aerosal® compared to a placebo treatment in the prognosis of sub-obstructive adenotonsillar hypertrophy present for at least six months.

Detailed Description

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Conditions

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Sleep Apnea, Obstructive

Keywords

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sleep apnea adenotonsillar hypertrophy salt sodium chloride

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Aerosal

This arm include all patients treated with Aerosal®

Group Type EXPERIMENTAL

Halotherapy

Intervention Type DEVICE

The treatment consist of 10 session of micronized iodized salt (sodium chloride) inhalation in a chamber that reproduces the environmental characteristics of a natural salt cave. Each daily session last 30 minutes.

Placebo

This arm include all patients treated with placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

The treatment consist of 10 sessions in a chamber that emulates the environmental characteristics of a natural salt cave but with no salt emanation. Each daily session last 30 minutes.

Interventions

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Halotherapy

The treatment consist of 10 session of micronized iodized salt (sodium chloride) inhalation in a chamber that reproduces the environmental characteristics of a natural salt cave. Each daily session last 30 minutes.

Intervention Type DEVICE

Placebo

The treatment consist of 10 sessions in a chamber that emulates the environmental characteristics of a natural salt cave but with no salt emanation. Each daily session last 30 minutes.

Intervention Type DEVICE

Other Intervention Names

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aerosal salt sodium chloride comparator

Eligibility Criteria

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Inclusion Criteria

* Sub-Obstructive Adenotonsillar Hypertrophy lasting from at least six months and associated with sleep disordered breathing (respiratory pauses or sleep-apnea) and/or recurrent sero-mucus otitis
* Suspension for more than 3 months from the date of any immunosuppressive treatments (cyclosporin, systemic steroids)

Exclusion Criteria

* Patients with acute bronchopulmonary disease, tuberculosis, severe hypertension, hyperthyroidism, cancer (chemotherapy), intoxication, heart failure, bronchial asthma.
* Iodine allergy
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Studi Gised

OTHER

Sponsor Role collaborator

Tecno Sun SRL

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matteo Gelardi, MD

Role: PRINCIPAL_INVESTIGATOR

University General Hospital Consortium of Bari

Locations

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University General Hospital Consortium

Bari, , Italy

Site Status

Countries

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Italy

References

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Gelardi M, Iannuzzi L, Greco Miani A, Cazzaniga S, Naldi L, De Luca C, Quaranta N. Double-blind placebo-controlled randomized clinical trial on the efficacy of Aerosal in the treatment of sub-obstructive adenotonsillar hypertrophy and related diseases. Int J Pediatr Otorhinolaryngol. 2013 Nov;77(11):1818-24. doi: 10.1016/j.ijporl.2013.08.013. Epub 2013 Aug 22.

Reference Type DERIVED
PMID: 24041858 (View on PubMed)

Other Identifiers

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AEROSAL3

Identifier Type: -

Identifier Source: org_study_id