AdenoidsPhase 4NAHChNCT01098071

Nasonex (Mometasone Furoate Nasal Spray) in Adenoids Hypertrophy in Children (P04367)

A Phase 4 study testing mometasone furoate nasal spray in people with Adenoids, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To document the short term \& long term effect of treatment with Nasonex (mometasone furoate nasal spray) in moderate to severe adenoids hypertrophy (which cause > 50% obstruction of the posterior choanae). Read more about this study

Who is it for?: Ages 2 to 11 years
Conditions the study is for: Adenoids
What is being tested?: mometasone furoate nasal spray
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: No sites listed yet
Study dates: 1 Aug 2008to 1 Sep 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 2 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

2-11 years of age, nasal obstruction for 3 months, adenoids hypertrophy > 50% of posterior choanae.

Who cannot join

adenoids hypertrophy < 50% of posterior choanae
recurrent epistaxis or immunodeficiency, severe septal deviation, kissing tonsils, choanal atresia, large masses, known allergy to nasonex (mometasone furoate nasal spray), chronic otitis media, cystic fibrosis, acute infection.

About this study

Official title: Open Label Pilot Trial, Evaluating the Role of Nasonex in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children

Conditions: Adenoids
Being tested: mometasone furoate nasal spray

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 SCH 32088, Nasonex
One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months

Study groups in NCT01098071
Study group	Role	What they receive
mometasone furoate nasal spray	Experimental	Not described Receives: Drug: mometasone furoate nasal spray

What is being measured

The primary outcome is the main question the study is designed to answer.

Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score
Clinical score (based on a 5 point grading system) was assessed for each of 5 nasal obstruction symptoms (oral/mouth breathing, snoring, restless sleep, frequent waking-ups during the night, and obstructive breathing during sleep). Each nasal obstruction symptom was estimated by the parent/guardian of the participant and scored on a scale of 0 (best) to 1 (worst). Total clinical score is a score on a scale (0 = no symptoms [best score] and 5 = worst symptoms [worst score]).
Measured: Baseline and Week 12
Degree of Posterior Choana Obstruction at Baseline and Week 12
The degree of obstruction of the posterior choana was assessed by endoscopy. Endoscopy grading consisted of Grade I (minimum), Grade II and Grade III (maximum). Grade I was defined as <50% obstruction, Grade II was defined as 50-75% obstruction, and Grade III was defined as >75% obstruction.
Measured: Baseline and Week 12
Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy
Measured: Baseline to 12 weeks

Secondary outcomes (5)

Severity of Rhinorrhea at Baseline and Week 12
Rhinorrhea is a symptom of allergic rhinitis. Rhinorrhea was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).
Measured: Baseline and Week 12
Severity of Nasal Congestion at Baseline and Week 12
Nasal congestion is a symptom of allergic rhinitis. Nasal congestion was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).
Measured: Baseline and Week 12
Severity of Nasal Itching at Baseline and Week 12
Nasal itching is a symptom of allergic rhinitis. Nasal itching was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).
Measured: Baseline and Week 12
Severity of Sneezing at Baseline and Week 12
Sneezing is a symptom of allergic rhinitis. Sneezing was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).
Measured: Baseline and Week 12
Severity of Eye Symptoms at Baseline and Week 12
Eye symptoms are a symptom of allergic rhinitis. Eye symptoms were assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).
Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20081 Sep 2009

First posted2 Apr 2010 (estimated)
Study start1 Aug 2008
Primary completion1 Sep 2009
Study completion1 Sep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AdenoidsStudies 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01098071
Sponsor's protocol ID: P04367 - Lebanon
Acronym: NAHCh
Status last verified: Feb 2022
First submitted: 1 Apr 2010
Last updated: 28 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Bitar MA, Mahfoud L, Nassar J, Dana R. Exploring the characteristics of children with obstructive adenoid responding to mometasone fuorate monohydrate: preliminary results. Eur Arch Otorhinolaryngol. 2013 Mar;270(3):931-7. doi: 10.1007/s00405-012-2155-8. Epub 2012 Aug 22.
PubMed 23010795

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Adenoids trials

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Label Pilot Trial, Evaluating the Role of Nasonex in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children
ClinicalTrials.gov ID: NCT01098071
Acronym / sponsor ID: NAHCh / P04367 - Lebanon
Conditions: Adenoids
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 1 Aug 2008 (actual)
Primary completion: 1 Sep 2009 (actual)
Study completion: 1 Sep 2009 (actual)
First posted: 2 Apr 2010 (estimated)
Results: Posted 29 Nov 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
mometasone furoate nasal spray	Experimental	Drug: mometasone furoate nasal spray

Who may qualify

Ages: 2 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

2-11 years of age, nasal obstruction for 3 months, adenoids hypertrophy > 50% of posterior choanae.

Key exclusion criteria (2 listed)

adenoids hypertrophy < 50% of posterior choanae
recurrent epistaxis or immunodeficiency, severe septal deviation, kissing tonsils, choanal atresia, large masses, known allergy to nasonex (mometasone furoate nasal spray), chronic otitis media, cystic fibrosis, acute infection.

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: SCH 32088, NasonexOne spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months	Drug	mometasone furoate nasal spray

Primary outcome

Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score
Time frame: Baseline and Week 12
Clinical score (based on a 5 point grading system) was assessed for each of 5 nasal obstruction symptoms (oral/mouth breathing, snoring, restless sleep, frequent waking-ups during the night, and obstructive breathing during sleep). Each nasal obstruction symptom was estimated by the parent/guardian of the participant and scored on a scale of 0 (best) to 1 (worst). Total clinical score is a score on a scale (0 = no symptoms [best score] and 5 = worst symptoms [worst score]).
Degree of Posterior Choana Obstruction at Baseline and Week 12
Time frame: Baseline and Week 12
The degree of obstruction of the posterior choana was assessed by endoscopy. Endoscopy grading consisted of Grade I (minimum), Grade II and Grade III (maximum). Grade I was defined as <50% obstruction, Grade II was defined as 50-75% obstruction, and Grade III was defined as >75% obstruction.
Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy
Time frame: Baseline to 12 weeks

5 secondary outcomes

Severity of Rhinorrhea at Baseline and Week 12
Time frame: Baseline and Week 12
Severity of Nasal Congestion at Baseline and Week 12
Time frame: Baseline and Week 12
Severity of Nasal Itching at Baseline and Week 12
Time frame: Baseline and Week 12
Severity of Sneezing at Baseline and Week 12
Time frame: Baseline and Week 12
Severity of Eye Symptoms at Baseline and Week 12
Time frame: Baseline and Week 12

Results and safety

Results posted to the registry on 29 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mometasone Furoate Nasal Spray	34	19

Primary outcome: Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score

Time frame: Baseline and Week 12. Mean (Full Range). Unit: Score on a scale

Measure	Mometasone Furoate Nasal Spray n = 19
Baseline score	3.89 (2 to 5)
Score at Week 12	1.26 (0 to 4)

Primary outcome: Degree of Posterior Choana Obstruction at Baseline and Week 12

Time frame: Baseline and Week 12. Mean (Full Range). Unit: Percent obstruction

Measure	Mometasone Furoate Nasal Spray n = 19
Baseline score	85 (70 to 90)
Score at Week 12	61 (40 to 80)

Population analysed: Only participants that completed the study are included.

Primary outcome: Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy

Time frame: Baseline to 12 weeks. Number. Unit: Participants

Measure	Mometasone Furoate Nasal Spray n = 19
Value	2

Population analysed: Evaluable population (per protocol population, ie, those participants without protocol violation of inclusion or exclusion criteria)

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mometasone Furoate Nasal Spray	0 of 34 (0%)	0 of 34 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23010795Bitar MA, Mahfoud L, Nassar J, Dana R. Exploring the characteristics of children with obstructive adenoid responding to mometasone fuorate monohydrate: preliminary results. Eur Arch Otorhinolaryngol. 2013 Mar;270(3):931-7. doi: 10.1007/s00405-012-2155-8. Epub 2012 Aug 22.
Individual participant dataSharing planned: No

Related trials for Adenoids

RecruitingPhase 1/2
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RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
RecruitingObservational study
SPARE-1st: Surgery Alone vs Surgery Plus Postoperative Radiotherapy for Sinonasal Adenoid Cystic Carcinoma
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RecruitingPhase 2
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RecruitingObservational study
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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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing mometasone furoate nasal spray in people with Adenoids, run by Organon and Co.

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 2 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: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Nov 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score (time frame: Baseline and Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01098071, which also lists 1 linked publication.

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 28 May 2024.