Efficacy of Aerosal® in the Treatment of Sub-Obstructive Adenotonsillar Hypertrophy and Related Diseases
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ClinicalTrials.gov Identifier: NCT01574885 |
Recruitment Status
:
Terminated
First Posted
: April 10, 2012
Last Update Posted
: November 8, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sleep Apnea, Obstructive | Device: Halotherapy Device: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 45 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Double-blind, Randomized, Placebo Controlled Study Evaluating the Efficacy of Aerosal® in the Treatment of Sub-Obstructive Adenotonsillar Hypertrophy and Related Diseases |
Study Start Date : | February 2012 |
Estimated Primary Completion Date : | February 2013 |
Estimated Study Completion Date : | April 2013 |
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:
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Placebo Comparator: Placebo
This arm include all patients treated with placebo
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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 Name: comparator
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- Percent change from baseline of adenotonsillar hypertrophy degree equal to or greater than 25% [ Time Frame: 2 weeks (10 sessions), 14 weeks ]
- Change from baseline of hypoacusis equal to or greater than 10 dB [ Time Frame: 2 weeks (10 sessions), 14 weeks ]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)
- Any change from baseline of tympanometry curve [ Time Frame: 2 weeks (10 sessions), 14 weeks ]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
- Any change from baseline of adenotonsillar hypertrophy degree [ Time Frame: 2 weeks (10 sessions), 14 weeks ]
- Any change from baseline of basal SpO2% levels [ Time Frame: 2 weeks (10 sessions), 14 weeks ]Any change from baseline of basal SpO2% mean levels as assessed by pulse-oximetry
- Any change from baseline of apnea index [ Time Frame: 2 weeks (10 sessions), 14 weeks ]Any change from baseline of apnea events in an hour (apnea index), as assessed by pulse-oximetry
- Any change from baseline of sleep time percentage with SpO2<95% [ Time Frame: 2 weeks (10 sessions), 14 weeks ]Any change from baseline of sleep time percentage with SpO2 levels under 95%, as assessed by pulse-oximetry
- Any change from baseline of hypoacusis [ Time Frame: 2 weeks (10 sessions), 14 weeks ]Any change from baseline of hypoacusis, detected at the frequencies of the tone range (5, 10, 20, 40 KHz)
- Number of reported adverse events [ Time Frame: 2 weeks (10 sessions), 14 weeks ]Number of reported adverse events (AEs) during treatment period or after the end of treatment, if suspected to be related with it

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Ages Eligible for Study: | 4 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574885
Italy | |
University General Hospital Consortium | |
Bari, Italy, 70124 |
Principal Investigator: | Matteo Gelardi, MD | University General Hospital Consortium of Bari |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Tecno Sun SRL |
ClinicalTrials.gov Identifier: | NCT01574885 History of Changes |
Other Study ID Numbers: |
AEROSAL3 |
First Posted: | April 10, 2012 Key Record Dates |
Last Update Posted: | November 8, 2012 |
Last Verified: | November 2012 |
Keywords provided by Tecno Sun SRL:
sleep apnea adenotonsillar hypertrophy salt sodium chloride |
Additional relevant MeSH terms:
Sleep Apnea Syndromes Hypertrophy Sleep Apnea, Obstructive Apnea Respiration Disorders Respiratory Tract Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Pathological Conditions, Anatomical |