Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000245493
Ethics application status
Approved
Date submitted
11/04/2007
Date registered
8/05/2007
Date last updated
27/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Montelukast for mild OSA in children
Scientific title
In children with mild obstructive sleep apnoea, is montelukast more effective than placebo in reducing the mixed and obstructive apnoea/hypopnoea index
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild obstructive sleep apnoea (OSA) in children 1784 0
Condition category
Condition code
Respiratory 1870 1870 0 0
Sleep apnoea

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Montelukast 4mg for children 2-5 years and 5 mg for children older than 5 years, given once in the evening as a chewable tablet for 8 weeks.
Intervention code [1] 1697 0
Treatment: Drugs
Comparator / control treatment
The control is a placebo chewable tablet given in the evening for 8 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 2658 0
Mixed & obstructive apnoea/hypopoea index (MOAHI) as measured by polysomnography (PSG)
Timepoint [1] 2658 0
At the end of the 8 week treatment period.
Secondary outcome [1] 4508 0
Quality of life, measures of behaviour, attention, and cognition.
Timepoint [1] 4508 0
Measured at baseline and at the end of the 8 week treatment period.

Eligibility
Key inclusion criteria
History of habitual snoring >= 4 nights per week for at least 6 months, Mixed Obstructive Apnoea-Hypopnoea Index (MOAHI) >1 and = 5 events per hour, Parents give written informed consent.
Minimum age
2 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
MOAHI outside the inclusion range, Craniofacial, Neuromuscular, syndromic, developmental or genetic abnormalities, Current or past use of montelukast, Current upper respiratory tract infection, Use of any inhaled or systemic corticosteroids or antibiotics in the past 4 weeks, Previous surgical treatment for OSA or adenotonsillectomy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed by central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The subjects are blinded as are the people assessing the outcomes
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
14/04/2007
Actual
14/04/2007
Date of last participant enrolment
Anticipated
Actual
30/11/2007
Date of last data collection
Anticipated
14/12/2007
Actual
14/12/2007
Sample size
Target
40
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 2017 0
Charities/Societies/Foundations
Name [1] 2017 0
Sydney Children's Hospital Foundation
Country [1] 2017 0
Australia
Primary sponsor type
University
Name
School of Women's and Children's Health, University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 1827 0
Hospital
Name [1] 1827 0
Sleep Unit, Sydney Children's Hospital
Address [1] 1827 0
Country [1] 1827 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3744 0
Sydney Children's Hospital
Ethics committee address [1] 3744 0
Ethics committee country [1] 3744 0
Australia
Date submitted for ethics approval [1] 3744 0
Approval date [1] 3744 0
27/03/2007
Ethics approval number [1] 3744 0
07/074

Summary
Brief summary
Obstructive sleep apnoea (OSA) is a relatively common condition in children with a peak incidence between 2-6 years, coincident with the maximal size of adenotonsillar tissue relative to the upper airway. OSA has effects on neurocognition and behaviour which may be reversed by adenotonsillectomy. However, surgical treatment carries risks which are increased in children with OSA and children under the age of 3 years. Recent studies have suggested that anti-inflammatory treatment with nasal corticosteroids or with anti-leukotriene agents may be an alternative to surgery. Montelukast is an anti-leukotriene receptor antagonist with minimal risk of adverse effects. A randomised double-blind placebo-controlled trial of montelukast for the treatment of OSA related to adenotonsillar hypertrophy in children is proposed. Following a sleep study (PSG) showing mild OSA, children will be randomised to a once daily dose of Montelukast or placebo for 8 weeks. At the end of treatment a repeat sleep study will be performed as well as measures of disease-specific quality of life, behaviour, attention and cognition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27800 0
Address 27800 0
Country 27800 0
Phone 27800 0
Fax 27800 0
Email 27800 0
Contact person for public queries
Name 10886 0
David McNamara
Address 10886 0
Sleep Unit
Level 3
Sydney Children's Hospital
High St
Randwick NSW 2031
Country 10886 0
Australia
Phone 10886 0
+61 2 93821210
Fax 10886 0
Email 10886 0
[email protected]
Contact person for scientific queries
Name 1814 0
David McNamara
Address 1814 0
Sleep Unit
Level 3
Sydney Children's Hospital
High St
Randwick NSW 2031
Country 1814 0
Australia
Phone 1814 0
+61 2 93821210
Fax 1814 0
Email 1814 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.