NCT01574885

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

November 8, 2012

Status Verified

November 1, 2012

Enrollment Period

1 year

First QC Date

April 5, 2012

Last Update Submit

November 7, 2012

Conditions

Sleep Apnea, Obstructive

Keywords

sleep apneaadenotonsillar hypertrophysaltsodium chloride

Outcome Measures

Primary Outcomes (1)

  • Percent change from baseline of adenotonsillar hypertrophy degree equal to or greater than 25%

    2 weeks (10 sessions), 14 weeks

Secondary Outcomes (8)

  • Change from baseline of hypoacusis equal to or greater than 10 dB

    2 weeks (10 sessions), 14 weeks

  • Any change from baseline of tympanometry curve

    2 weeks (10 sessions), 14 weeks

  • Any change from baseline of adenotonsillar hypertrophy degree

    2 weeks (10 sessions), 14 weeks

  • Any change from baseline of basal SpO2% levels

    2 weeks (10 sessions), 14 weeks

  • Any change from baseline of apnea index

    2 weeks (10 sessions), 14 weeks

  • +3 more secondary outcomes

Study Arms (2)

Aerosal

EXPERIMENTAL

This arm include all patients treated with Aerosal®

Device: Halotherapy

Placebo

PLACEBO COMPARATOR

This arm include all patients treated with placebo

Device: Placebo

Interventions

HalotherapyDEVICE

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.

Also known as: aerosal, salt, sodium chloride
Aerosal
PlaceboDEVICE

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.

Also known as: comparator
Placebo

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • Patients with acute bronchopulmonary disease, tuberculosis, severe hypertension, hyperthyroidism, cancer (chemotherapy), intoxication, heart failure, bronchial asthma.
  • Iodine allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University General Hospital Consortium

Bari, 70124, Italy

Location

Related Publications (1)

  • 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.

    PMID: 24041858DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Matteo Gelardi, MD

    University General Hospital Consortium of Bari

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2012

First Posted

April 10, 2012

Study Start

February 1, 2012

Primary Completion

February 1, 2013

Study Completion

April 1, 2013

Last Updated

November 8, 2012

Record last verified: 2012-11

Locations

IT(1)