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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Device: Halotherapy Device: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2012
Estimated Primary Completion Date : February 2013
Estimated Study Completion Date : April 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: Aerosal
This arm include all patients treated with Aerosal®
 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
Placebo Comparator: Placebo
This arm include all patients treated with placebo
 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


Outcome Measures
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Primary Outcome Measures :
  1. Percent change from baseline of adenotonsillar hypertrophy degree equal to or greater than 25% [ Time Frame: 2 weeks (10 sessions), 14 weeks ]

Secondary Outcome Measures :
  1. 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)

  2. 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

  3. Any change from baseline of adenotonsillar hypertrophy degree [ Time Frame: 2 weeks (10 sessions), 14 weeks ]
  4. 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

  5. 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

  6. 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

  7. 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)

  8. 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


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574885


Locations
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Italy
University General Hospital Consortium
Bari, Italy, 70124
Sponsors and Collaborators
Tecno Sun SRL
Centro Studi Gised
Investigators
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Principal Investigator: Matteo Gelardi, MD University General Hospital Consortium of Bari
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Tecno Sun SRL
ClinicalTrials.gov Identifier: NCT01574885     History of Changes
Other Study ID Numbers: AEROSAL3
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: November 8, 2012
Last Verified: November 2012
Keywords provided by Tecno Sun SRL:
sleep apnea
adenotonsillar hypertrophy
salt
sodium chloride
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Hypertrophy
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pathological Conditions, Anatomical