TerminatedPhase 2

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

Italy45 participantsStarted 2012-02

Plain-language 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.

Who can participate

Age range4 Years – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 2 weeks (10 sessions), 14 weeks

Trial details

NCT IDNCT01574885

SponsorTecno Sun SRL

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-02

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