Clinical trial NCT01574885: Efficacy of Aerosal® in the Treatment of Sub-Obstructive Adenotonsillar Hypertrophy and Related Diseases
Official title: Double-blind, Randomized, Placebo Controlled Study Evaluating the Efficacy of Aerosal® in the Treatment of Sub-Obstructive Adenotonsillar Hypertrophy and Related Diseases
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Sleep Apnea, Obstructive
Keywords: sleep apnea
adenotonsillar hypertrophy
salt
sodium chloride
Lead sponsor: Tecno Sun SRL
Sponsor class: INDUSTRY
Collaborators: name: Centro Studi Gised
First posted: 2012-04-10
Enrollment: 45
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percent change from baseline of adenotonsillar hypertrophy degree equal to or greater than 25%
timeFrame: 2 weeks (10 sessions), 14 weeks
Secondary outcomes:
measure: Change from baseline of hypoacusis equal to or greater than 10 dB
timeFrame: 2 weeks (10 sessions), 14 weeks
measure: Any change from baseline of tympanometry curve
timeFrame: 2 weeks (10 sessions), 14 weeks
measure: Any change from baseline of adenotonsillar hypertrophy degree
timeFrame: 2 weeks (10 sessions), 14 weeks
measure: Any change from baseline of basal SpO2% levels
timeFrame: 2 weeks (10 sessions), 14 weeks
measure: Any change from baseline of apnea index
timeFrame: 2 weeks (10 sessions), 14 weeks
measure: Any change from baseline of sleep time percentage with SpO2<95%
timeFrame: 2 weeks (10 sessions), 14 weeks
measure: Any change from baseline of hypoacusis
timeFrame: 2 weeks (10 sessions), 14 weeks
measure: Number of reported adverse events
timeFrame: 2 weeks (10 sessions), 14 weeks
Other outcomes:
Locations:
city: Bari
country: Italy
facility: University General Hospital Consortium
Study officials:
affiliation: University General Hospital Consortium of Bari
name: Matteo Gelardi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gelardi M, Iannuzzi L, Greco Miani A, Cazzaniga S, Naldi L, De Luca C, Quaranta N. Double-blind placebo-controlled randomized clinical trial on the efficacy of Aerosal in the treatment of sub-obstructive adenotonsillar hypertrophy and related diseases. Int J Pediatr Otorhinolaryngol. 2013 Nov;77(11):1818-24. doi: 10.1016/j.ijporl.2013.08.013. Epub 2013 Aug 22.