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

This study has been terminated.
Sponsor:
Collaborator:
Centro Studi Gised
Information provided by (Responsible Party):
Tecno Sun SRL
ClinicalTrials.gov Identifier:
NCT01574885
First received: April 5, 2012
Last updated: November 7, 2012
Last verified: November 2012

April 5, 2012
November 7, 2012
February 2012
February 2013   (final data collection date for primary outcome measure)
Percent change from baseline of adenotonsillar hypertrophy degree equal to or greater than 25% [ Time Frame: 2 weeks (10 sessions), 14 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01574885 on ClinicalTrials.gov Archive Site
  • Change from baseline of hypoacusis equal to or greater than 10 dB [ Time Frame: 2 weeks (10 sessions), 14 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks (10 sessions), 14 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2 weeks (10 sessions), 14 weeks ] [ Designated as safety issue: No ]
  • Any change from baseline of basal SpO2% levels [ Time Frame: 2 weeks (10 sessions), 14 weeks ] [ Designated as safety issue: No ]
    Any change from baseline of basal SpO2% mean levels as assessed by pulse-oximetry
  • Any change from baseline of apnea index [ Time Frame: 2 weeks (10 sessions), 14 weeks ] [ Designated as safety issue: No ]
    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% [ Time Frame: 2 weeks (10 sessions), 14 weeks ] [ Designated as safety issue: No ]
    Any change from baseline of sleep time percentage with SpO2 levels under 95%, as assessed by pulse-oximetry
  • Any change from baseline of hypoacusis [ Time Frame: 2 weeks (10 sessions), 14 weeks ] [ Designated as safety issue: No ]
    Any change from baseline of hypoacusis, detected at the frequencies of the tone range (5, 10, 20, 40 KHz)
  • Number of reported adverse events [ Time Frame: 2 weeks (10 sessions), 14 weeks ] [ Designated as safety issue: Yes ]
    Number of reported adverse events (AEs) during treatment period or after the end of treatment, if suspected to be related with it
Same as current
Not Provided
Not Provided
 
Efficacy of Aerosal® in the Treatment of Sub-Obstructive Adenotonsillar Hypertrophy and Related Diseases
Double-blind, Randomized, Placebo Controlled Study Evaluating the Efficacy of Aerosal® in the Treatment of Sub-Obstructive Adenotonsillar Hypertrophy and Related Diseases

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Sleep Apnea, Obstructive
  • Device: Halotherapy
    The treatment consist of 10 session of micronized iodized salt (sodium chloride) inhalation in a chamber that reproduces the environmental characteristics of a natural salt cave. Each daily session last 30 minutes.
    Other Names:
    • aerosal
    • halotherapy
    • salt
    • sodium chloride
  • Device: Placebo
    The treatment consist of 10 sessions in a chamber that emulates the environmental characteristics of a natural salt cave but with no salt emanation. Each daily session last 30 minutes.
    Other Names:
    • placebo
    • comparator
  • Experimental: Aerosal
    This arm include all patients treated with Aerosal®
    Intervention: Device: Halotherapy
  • Placebo Comparator: Placebo
    This arm include all patients treated with placebo
    Intervention: Device: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
45
April 2013
February 2013   (final data collection date for primary outcome measure)

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
Both
4 Years to 12 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01574885
AEROSAL3
Yes
Tecno Sun SRL
Tecno Sun SRL
Centro Studi Gised
Principal Investigator: Matteo Gelardi, MD University General Hospital Consortium of Bari
Tecno Sun SRL
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP