Obstructive Sleep Apnea (Mild, Moderate, Severe) as Per PolysomnographyPhase 3Nasonex OSANCT01671852
Intranasal Mometasone in Children With Obstructive Sleep Apnea Due to Adenotonsillar Hypertrophy
A Phase 3 study testing Mometasone furoate nasal spray in people with Obstructive Sleep Apnea (Mild, Moderate, Severe) as Per Polysomnography, run by Children's & Women's Health Centre of British Columbia at 1 site in Canada.
Trial summary
Obstructive sleep apnea (OSA) in children is a disorder of breathing during sleep characterized by prolonged partial upper airway obstruction and/or intermittent complete obstruction (obstructive apnea) that disrupts normal breathing during sleep1. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Obstructive Sleep Apnea (Mild, Moderate, Severe) as Per Polysomnography
- What is being tested?
- Mometasone furoate nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to Jul 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between age 3 and 16 with objectively diagnosed OSA (mild, moderate, severe) as per polysomnography (AHI ≥ 1/h, where AHI is the sum of obstructive and mixed apneas and obstructive hypopneas).
Who cannot join
- Children with malformation syndromes or craniofacial anomalies
- Children with neuromuscular disorders
- Children with morbid obesity (body mass index ≥ 40)
- Children with asthma requiring steroid treatment
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Women's and Children's Hospital
Vancouver, British Columbia, V6H 3N1
About this study
Official title: A Randomized Controlled Trial of Intranasal Mometasone in Children With Obstructive Sleep Apnea Due to Adenotonsillar Hypertrophy
Obstructive sleep apnea (OSA) in children is a disorder of breathing during sleep characterized by prolonged partial upper airway obstruction and/or intermittent complete obstruction (obstructive apnea) that disrupts normal breathing during sleep1. The condition occurs in 2-5% of children and can occur at any age, but it is most common in children between the ages of 2 to 62,3. Untreated OSA is associated with lung disease, heart disease, growth delay, poor learning and behavioral problems such as inattention and hyperactivity. The most common underlying risk factor for the development of OSA is enlargement of tonsils and adenoids. Given the potential risk of complications associated with surgery of the tonsils and adenoids, medications to shrink the adenoids without requiring surgery have been considered, in particular intranasal corticosteroids (INCSs) which is a nose spray. A recent Cochrane systematic review suggested a short-term benefit of INCSs in children with mild to moderate OSA4. The authors recommended that further randomised controlled studies were required to evaluate the efficacy of INCSs in children with OSA. In particular they recommended that future studies should employ sleep studies to look for any improvement with INCSs, and should include children with more severe OSA, as these are the patients at the greatest risk of complications of surgery and would benefit most from a non-surgical treatment. The purpose of this study is therefore to explore the efficacy of INCSs in children with the full spectrum of OSA severity, including sleep study analysis., and longer term follow-up.
- Being tested
- Mometasone furoate nasal spray, Placebo
- Medical subject headings
- Sleep Apnea, Obstructive, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone furoate nasal sprayDrug
Also called Nasonex
Included patients will be randomized to a sequence of treatments including a medicated nasal spray and a saline nasal spray. The medicated group will receive Mometasone nasal sprays at the dosage outlined below for 8 weeks. The placebo group will receive saline nasal sprays for an equal duration. Informed consent of the parents or legal guardians will be obtained.
For patients that are between age 3 to 11 years and if they are randomized to the medicated group, they will use pediatric dosing of Mometasone nasal sprays, 1 spray (50 mcg) in each nostril once daily for 8 weeks. For patients that are older than age 12 and if they are randomized to the medicated group, they will use adult dosing of Mometasone nasal sprays, 2 sprays (100mcg) in each nostril twice daily for 8 weeks.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Nasonex | Active comparator | The intervention group will receive mometasone nasal sprays at the dosage outlined below for 8 weeks. For patients that are between age 3 to 11 years and if they are randomized to the medicated group, they will use pediatric dosing of Mometasone nasal sprays, 1 spray (50 mcg) in each nostril once daily for 8 weeks. For patients that are older than age 12 and if they are randomized to the medicated group, they will use adult dosing of Mometasone nasal sprays, 2 sprays (100mcg) in each nostril twice daily for 8 weeks. Receives: Drug: Mometasone furoate nasal spray |
| Saline | Placebo comparator | The placebo group will receive saline nasal sprays for 8 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index (AHI)
This wil be measured by polysomnography.
Measured: 8 weeks
Secondary outcomes (8)
Respiratory Disturbance Index
This will be measured by polysomnography.
Measured: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
Desaturation index
This will be measured by polysomnography.
Measured: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
Respiratory arousal index
This will be measured by polysomnography.
Measured: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
Nadir of arterial oxygen saturation
This will be measured by polysomnography.
Measured: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
Mean arterial oxygen saturation
This will be measured by polysomnography.
Measured: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
Avoidance of surgical treatment for OSA
This will be measured by polysomnography.
Measured: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
Clinical symptom score (based on parent repot of, for example, snoring, witnessed apnea, daytime sleepiness etc.)
This will be measured by polysomnography.
Measured: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
Tonsillar size (on an ordinal scale from 0 [not visible] to +4 [tonsils touch])
This will be measured by polysomnography.
Measured: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Could not obtain funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (Mild, Moderate, Severe) as Per PolysomnographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's & Women's Health Centre of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neil Chadha, Children's & Women's Health Centre of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671852
- Sponsor's protocol ID
- H12-01653
- Acronym
- Nasonex OSA
- Status last verified
- Jul 2015
- First submitted
- 5 Jul 2012
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Intranasal Mometasone in Children With Obstructive Sleep Apnea Due to Adenotonsillar Hypertrophy
- ClinicalTrials.gov ID
- NCT01671852
- Acronym / sponsor ID
- Nasonex OSA / H12-01653
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Could not obtain funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's & Women's Health Centre of British ColumbiaUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 24 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstructive sleep apnea (OSA) in children is a disorder of breathing during sleep characterized by prolonged partial upper airway obstruction and/or intermittent complete obstruction (obstructive apnea) that disrupts normal breathing during sleep1. The condition occurs in 2-5% of children and can occur at any age, but it is most common in children between the ages of 2 to 62,3. Untreated OSA is associated with lung disease, heart disease, growth delay, poor learning and behavioral problems such as inattention and hyperactivity. The most common underlying risk factor for the development of OSA is enlargement of tonsils and adenoids. Given the potential risk of complications associated with surgery of the tonsils and adenoids, medications to shrink the adenoids without requiring surgery have been considered, in particular intranasal corticosteroids (INCSs) which is a nose spray. A recent Cochrane systematic review suggested a short-term benefit of INCSs in children with mild to moderate OSA4. The authors recommended that further randomised controlled studies were required to evaluate the efficacy of INCSs in children with OSA. In particular they recommended that future studies should employ sleep studies to look for any improvement with INCSs, and should include children with more severe OSA, as these are the patients at the greatest risk of complications of surgery and would benefit most from a non-surgical treatment. The purpose of this study is therefore to explore the efficacy of INCSs in children with the full spectrum of OSA severity, including sleep study analysis., and longer term follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasonex | Active comparator | Drug: Mometasone furoate nasal sprayThe intervention group will receive mometasone nasal sprays at the dosage outlined below for 8 weeks. For patients that are between age 3 to 11 years and if they are randomized to the medicated group, they will use pediatric dosing of Mometasone nasal sprays, 1 spray (50 mcg) in each nostril once daily for 8 weeks. For patients that are older than age 12 and if they are randomized to the medicated group, they will use adult dosing of Mometasone nasal sprays, 2 sprays (100mcg) in each nostril twice daily for 8 weeks. |
| Saline | Placebo comparator | Drug: PlaceboThe placebo group will receive saline nasal sprays for 8 weeks. |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between age 3 and 16 with objectively diagnosed OSA (mild, moderate, severe) as per polysomnography (AHI ≥ 1/h, where AHI is the sum of obstructive and mixed apneas and obstructive hypopneas).
Key exclusion criteria (4 listed)
- Children with malformation syndromes or craniofacial anomalies
- Children with neuromuscular disorders
- Children with morbid obesity (body mass index ≥ 40)
- Children with asthma requiring steroid treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mometasone furoate nasal sprayAlso: NasonexIncluded patients will be randomized to a sequence of treatments including a medicated nasal spray and a saline nasal spray. The medicated group will receive Mometasone nasal sprays at the dosage outlined below for 8 weeks. The placebo group will receive saline nasal sprays for an equal duration. Informed consent of the parents or legal guardians will be obtained. For patients that are between age 3 to 11 years and if they are randomized to the medicated group, they will use pediatric dosing of Mometasone nasal sprays, 1 spray (50 mcg) in each nostril once daily for 8 weeks. For patients that are older than age 12 and if they are randomized to the medicated group, they will use adult dosing of Mometasone nasal sprays, 2 sprays (100mcg) in each nostril twice daily for 8 weeks. | Drug | Nasonex |
| Placebo | Drug | Saline |
Primary outcome
Apnea Hypopnea Index (AHI)
Time frame: 8 weeks
This wil be measured by polysomnography.
8 secondary outcomes
Respiratory Disturbance Index
Time frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
Desaturation index
Time frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
Respiratory arousal index
Time frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
Nadir of arterial oxygen saturation
Time frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
Mean arterial oxygen saturation
Time frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
Avoidance of surgical treatment for OSA
Time frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
Clinical symptom score (based on parent repot of, for example, snoring, witnessed apnea, daytime sleepiness etc.)
Time frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
Tonsillar size (on an ordinal scale from 0 [not visible] to +4 [tonsils touch])
Time frame: At baseline and after each phase of treatment (i.e. after initial 8 weeks invention and again after second 8 weeks intervention)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mometasone furoate nasal spray in people with Obstructive Sleep Apnea (Mild, Moderate, Severe) as Per Polysomnography, run by Children's & Women's Health Centre of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea Hypopnea Index (AHI) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2015.