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

Primary Purpose

Sleep Apnea, Obstructive

Status

Terminated

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

Halotherapy

Placebo

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring sleep apnea, adenotonsillar hypertrophy, salt, sodium chloride

Eligibility Criteria

4 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University General Hospital Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aerosal

Placebo

Arm Description

This arm include all patients treated with Aerosal®

This arm include all patients treated with placebo

Outcomes

Primary Outcome Measures

Percent change from baseline of adenotonsillar hypertrophy degree equal to or greater than 25%

Secondary Outcome Measures

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)

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

Any change from baseline of adenotonsillar hypertrophy degree

Any change from baseline of basal SpO2% levels

Any change from baseline of basal SpO2% mean levels as assessed by pulse-oximetry

Any change from baseline of apnea index

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%

Any change from baseline of sleep time percentage with SpO2 levels under 95%, as assessed by pulse-oximetry

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)

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

Full Information

NCT ID

NCT01574885

First Posted

April 5, 2012

Last Updated

November 7, 2012

Sponsor

Tecno Sun SRL

Collaborators

Centro Studi Gised

1. Study Identification

Unique Protocol Identification Number

NCT01574885

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Terminated

Study Start Date

February 2012 (undefined)

Primary Completion Date

February 2013 (Anticipated)

Study Completion Date

April 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tecno Sun SRL

Collaborators

Centro Studi Gised

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea, Obstructive

Keywords

sleep apnea, adenotonsillar hypertrophy, salt, sodium chloride

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aerosal

Arm Type

Experimental

Arm Description

This arm include all patients treated with Aerosal®

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

This arm include all patients treated with placebo

Intervention Type

Device

Intervention Name(s)

Halotherapy

Other Intervention Name(s)

aerosal, salt, sodium chloride

Intervention Description

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

Intervention Name(s)

Placebo

Other Intervention Name(s)

comparator

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percent change from baseline of adenotonsillar hypertrophy degree equal to or greater than 25%

Time Frame

2 weeks (10 sessions), 14 weeks

Secondary Outcome Measure Information:

Title

Change from baseline of hypoacusis equal to or greater than 10 dB

Description

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)

Time Frame

2 weeks (10 sessions), 14 weeks

Title

Any change from baseline of tympanometry curve

Description

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

Time Frame

2 weeks (10 sessions), 14 weeks

Title

Any change from baseline of adenotonsillar hypertrophy degree

Time Frame

2 weeks (10 sessions), 14 weeks

Title

Any change from baseline of basal SpO2% levels

Description

Any change from baseline of basal SpO2% mean levels as assessed by pulse-oximetry

Time Frame

2 weeks (10 sessions), 14 weeks

Title

Any change from baseline of apnea index

Description

Any change from baseline of apnea events in an hour (apnea index), as assessed by pulse-oximetry

Time Frame

2 weeks (10 sessions), 14 weeks

Title

Any change from baseline of sleep time percentage with SpO2<95%

Description

Any change from baseline of sleep time percentage with SpO2 levels under 95%, as assessed by pulse-oximetry

Time Frame

2 weeks (10 sessions), 14 weeks

Title

Any change from baseline of hypoacusis

Description

Any change from baseline of hypoacusis, detected at the frequencies of the tone range (5, 10, 20, 40 KHz)

Time Frame

2 weeks (10 sessions), 14 weeks

Title

Number of reported adverse events

Description

Number of reported adverse events (AEs) during treatment period or after the end of treatment, if suspected to be related with it

Time Frame

2 weeks (10 sessions), 14 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matteo Gelardi, MD

Organizational Affiliation

University General Hospital Consortium of Bari

Official's Role

Principal Investigator

Facility Information:

Facility Name

University General Hospital Consortium

City

Bari

ZIP/Postal Code

70124

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

24041858

Citation

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.

Results Reference

derived

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

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