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

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ClinicalTrials.gov Identifier: NCT01574885
Recruitment Status : Terminated
First Posted : April 10, 2012
Last Update Posted : November 8, 2012
Sponsor:
Collaborator:
Centro Studi Gised
Information provided by (Responsible Party):
Tecno Sun SRL

Tracking Information
First Submitted Date  ICMJE April 5, 2012
First Posted Date  ICMJE April 10, 2012
Last Update Posted Date November 8, 2012
Study Start Date  ICMJE February 2012
Estimated Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2012)
Percent change from baseline of adenotonsillar hypertrophy degree equal to or greater than 25% [ Time Frame: 2 weeks (10 sessions), 14 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01574885 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2012)
  • Change from baseline of hypoacusis equal to or greater than 10 dB [ Time Frame: 2 weeks (10 sessions), 14 weeks ]
    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 ]
    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 ]
  • Any change from baseline of basal SpO2% levels [ Time Frame: 2 weeks (10 sessions), 14 weeks ]
    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 ]
    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 ]
    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 ]
    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 ]
    Number of reported adverse events (AEs) during treatment period or after the end of treatment, if suspected to be related with it
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Aerosal® in the Treatment of Sub-Obstructive Adenotonsillar Hypertrophy and Related Diseases
Official Title  ICMJE Double-blind, Randomized, Placebo Controlled Study Evaluating the Efficacy of Aerosal® in the Treatment of Sub-Obstructive Adenotonsillar Hypertrophy and Related Diseases
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sleep Apnea, Obstructive
Intervention  ICMJE
  • 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
    • 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 Name: comparator
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 7, 2012)
45
Original Estimated Enrollment  ICMJE
 (submitted: April 7, 2012)
64
Estimated Study Completion Date  ICMJE April 2013
Estimated Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01574885
Other Study ID Numbers  ICMJE AEROSAL3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tecno Sun SRL
Study Sponsor  ICMJE Tecno Sun SRL
Collaborators  ICMJE Centro Studi Gised
Investigators  ICMJE
Principal Investigator: Matteo Gelardi, MD University General Hospital Consortium of Bari
PRS Account Tecno Sun SRL
Verification Date November 2012

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