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

Phase 2

Terminated

• Conditions: Sleep Apnea, Obstructive
• Interventions: Device: Halotherapy; Device: Placebo

• Registration Number: NCT01574885
• Lead Sponsor: Tecno Sun SRL

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-04-05
• Study First Submitted QC: 2012-04-07
• Study First Posted: 2012-04-10
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-07
• Last Update Posted: 2012-11-08
• Primary Completion: 2013-02
• Study Completion: 2013-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aerosal	Halotherapy	This arm include all patients treated with Aerosal®
Placebo	Placebo	This arm include all patients treated with placebo

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline of hypoacusis equal to or greater than 10 dB	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	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	2 weeks (10 sessions), 14 weeks
Any change from baseline of basal SpO2% levels	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	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%	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	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	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

Trial Locations

Locations (1)

University General Hospital Consortium; 🇮🇹 Bari, Italy