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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
  Purpose
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 Intervention Phase
Sleep Apnea, Obstructive Device: Halotherapy Device: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Tecno Sun SRL:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 45
Study Start Date: February 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574885

Locations
Italy
University General Hospital Consortium
Bari, Italy, 70124
Sponsors and Collaborators
Tecno Sun SRL
Centro Studi Gised
Investigators
Principal Investigator: Matteo Gelardi, MD University General Hospital Consortium of Bari
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tecno Sun SRL
ClinicalTrials.gov Identifier: NCT01574885     History of Changes
Other Study ID Numbers: AEROSAL3
Study First Received: April 5, 2012
Last Updated: November 7, 2012

Keywords provided by Tecno Sun SRL:
sleep apnea
adenotonsillar hypertrophy
salt
sodium chloride

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Hypertrophy
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 21, 2017