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

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01574885
• Other study ID #: AEROSAL3
• Status: Terminated
• Phase: Phase 2
• First received: April 5, 2012
• Last updated: November 7, 2012
• Start date: February 2012
• Est. completion date: April 2013

Study information

• Verified date: November 2012
• Source: Tecno Sun SRL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: National Institute of HealthItaly: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: April 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertrophy
• Sleep Apnea, Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	University General Hospital Consortium	Bari

Sponsors (2)

Lead Sponsor	Collaborator
Tecno Sun SRL	Centro Studi Gised

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline of adenotonsillar hypertrophy degree equal to or greater than 25%		2 weeks (10 sessions), 14 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	Any change from baseline of adenotonsillar hypertrophy degree		2 weeks (10 sessions), 14 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes