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

Tecno Sun

Status and phase: Terminated; Phase 2

Conditions: Sleep Apnea, Obstructive

Treatments: Device: Halotherapy; Device: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01574885

AEROSAL3

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 2 patient groups, including a placebo group

Aerosal

Experimental group

Description:

This arm include all patients treated with Aerosal®

Treatment:

Device: Halotherapy

Placebo

Placebo Comparator group

Description:

This arm include all patients treated with placebo

Treatment:

Device: Placebo