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

Tecno Sun SRL1 site in 1 country45 target enrollmentFebruary 2012

ConditionsSleep Apnea, Obstructive

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Sleep Apnea, Obstructive
Sponsor: Tecno Sun SRL
Enrollment: 45
Locations: 1
Primary Endpoint: Percent change from baseline of adenotonsillar hypertrophy degree equal to or greater than 25%
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

April 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Tecno Sun SRL

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: 2 weeks (10 sessions), 14 weeks

Secondary Outcomes

Change from baseline of hypoacusis equal to or greater than 10 dB(2 weeks (10 sessions), 14 weeks)
Any change from baseline of tympanometry curve(2 weeks (10 sessions), 14 weeks)
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 apnea index(2 weeks (10 sessions), 14 weeks)
Any change from baseline of sleep time percentage with SpO2<95%(2 weeks (10 sessions), 14 weeks)
Any change from baseline of hypoacusis(2 weeks (10 sessions), 14 weeks)
Number of reported adverse events(2 weeks (10 sessions), 14 weeks)