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

Double-blind, Randomized, Placebo Controlled Study Evaluating the Efficacy of Aerosal® in the Treatment of Sub-Obstructive Adenotonsillar Hypertrophy and Related Diseases

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.

Study Overview

• Status: Terminated
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Device: Halotherapy; Device: Placebo

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70124
    • University General Hospital Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerosal; This arm include all patients treated with Aerosal®	Device: 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.; Other Names: sodium chloride; aerosal; salt
Placebo Comparator: Placebo; This arm include all patients treated with placebo	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.; Other Names: comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change from baseline of adenotonsillar hypertrophy degree equal to or greater than 25%	2 weeks (10 sessions), 14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline of hypoacusis equal to or greater than 10 dB	Change from baseline of hypoacusis equal to or greater than 10 dB, detected at the frequencies of the tone range (5, 10, 20, 40 KHz)	2 weeks (10 sessions), 14 weeks
Any change from baseline of tympanometry curve	Any change from baseline of tympanometry, defined as the passage from curve type B to curve type C/A or from curve type C to curve type A	2 weeks (10 sessions), 14 weeks
Any change from baseline of adenotonsillar hypertrophy degree		2 weeks (10 sessions), 14 weeks
Any change from baseline of basal SpO2% levels	Any change from baseline of basal SpO2% mean levels as assessed by pulse-oximetry	2 weeks (10 sessions), 14 weeks
Any change from baseline of apnea index	Any change from baseline of apnea events in an hour (apnea index), as assessed by pulse-oximetry	2 weeks (10 sessions), 14 weeks
Any change from baseline of sleep time percentage with SpO2<95%	Any change from baseline of sleep time percentage with SpO2 levels under 95%, as assessed by pulse-oximetry	2 weeks (10 sessions), 14 weeks
Any change from baseline of hypoacusis	Any change from baseline of hypoacusis, detected at the frequencies of the tone range (5, 10, 20, 40 KHz)	2 weeks (10 sessions), 14 weeks
Number of reported adverse events	Number of reported adverse events (AEs) during treatment period or after the end of treatment, if suspected to be related with it	2 weeks (10 sessions), 14 weeks

Collaborators and Investigators

• Sponsor: Tecno Sun SRL
• Collaborators: Centro Studi Gised
• Investigators: Principal Investigator: Matteo Gelardi, MD, University General Hospital Consortium of Bari

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Anticipated): February 1, 2013
• Study Completion (Anticipated): April 1, 2013

Study Registration Dates

• First Submitted: April 5, 2012
• First Submitted That Met QC Criteria: April 7, 2012
• First Posted (Estimate): April 10, 2012

Study Record Updates

• Last Update Posted (Estimate): November 8, 2012
• Last Update Submitted That Met QC Criteria: November 7, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: adenotonsillar hypertrophy; sleep apnea; sodium chloride; salt
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Pathological Conditions, Anatomical; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertrophy
• Other Study ID Numbers: AEROSAL3