Trial · NCT01098071
Nasonex (Mometasone Furoate Nasal Spray) in Adenoids Hypertrophy in Children (P04367)
NCT01098071, Phase 4, Completed, Organon and Co; results first posted 2011-11-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Nasonex (Mometasone Furoate Nasal Spray) in Adenoids Hypertrophy in Children (P04367). Trials, record NCT01098071. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01098071
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nasonex (Mometasone Furoate Nasal Spray) in Adenoids Hypertrophy in Children (P04367)
- NCT number
- NCT01098071
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 34 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Adenoids
- Interventions
- mometasone furoate nasal spray
- First posted
- 2010-04-02
- Last updated
- 2024-05-28
- Results first posted
- 2011-11-29
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score | 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 \[worst score\]). |
| Primary | Degree of Posterior Choana Obstruction at Baseline and Week 12 | 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. |
| Primary | Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy | Baseline to 12 weeks | |
| Secondary | Severity of Rhinorrhea at Baseline and Week 12 | 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 \[worst score\]). |
| Secondary | Severity of Nasal Congestion at Baseline and Week 12 | 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 \[worst score\]). |
| Secondary | Severity of Nasal Itching at Baseline and Week 12 | 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 \[worst score\]). |
| Secondary | Severity of Sneezing at Baseline and Week 12 | 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 \[worst score\]). |
| Secondary | Severity of Eye Symptoms at Baseline and Week 12 | 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 \[worst score\]). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score | Baseline and Week 12 | Score on a scale | MEAN | |
| PRIMARY | Degree of Posterior Choana Obstruction at Baseline and Week 12 | Baseline and Week 12 | Only participants that completed the study are included. | Percent obstruction | MEAN |
| PRIMARY | Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy | Baseline to 12 weeks | Evaluable population (per protocol population, ie, those participants without protocol violation of inclusion or exclusion criteria) | Participants | NUMBER |
| SECONDARY | Severity of Rhinorrhea at Baseline and Week 12 | Baseline and Week 12 | Participants suspected to have allergic rhinitis | Score on a scale | MEAN |
| SECONDARY | Severity of Nasal Congestion at Baseline and Week 12 | Baseline and Week 12 | Participants suspected to have allergic rhinitis | Score on a scale | MEAN |
| SECONDARY | Severity of Nasal Itching at Baseline and Week 12 | Baseline and Week 12 | Participants suspected to have allergic rhinitis | Score on a scale | MEAN |
| SECONDARY | Severity of Sneezing at Baseline and Week 12 | Baseline and Week 12 | Participants suspected to have allergic rhinitis | Score on a scale | MEAN |
| SECONDARY | Severity of Eye Symptoms at Baseline and Week 12 | Baseline and Week 12 | Participants suspected to have allergic rhinitis | Score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score | Mometasone Furoate Nasal Spray | Baseline score | 3.89 | Full Range 2 to 5 | Score on a scale |
| Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score | Mometasone Furoate Nasal Spray | Score at Week 12 | 1.26 | Full Range 0 to 4 | Score on a scale |
| Degree of Posterior Choana Obstruction at Baseline and Week 12 | Mometasone Furoate Nasal Spray | Baseline score | 85 | Full Range 70 to 90 | Percent obstruction |
| Degree of Posterior Choana Obstruction at Baseline and Week 12 | Mometasone Furoate Nasal Spray | Score at Week 12 | 61 | Full Range 40 to 80 | Percent obstruction |
| Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy | Mometasone Furoate Nasal Spray | 2 | Participants | ||
| Severity of Rhinorrhea at Baseline and Week 12 | Mometasone Furoate Nasal Spray | Baseline score | 0.95 | Full Range 0 to 3 | Score on a scale |
| Severity of Rhinorrhea at Baseline and Week 12 | Mometasone Furoate Nasal Spray | Score at Week 12 | 0.37 | Full Range 0 to 2 | Score on a scale |
| Severity of Nasal Congestion at Baseline and Week 12 | Mometasone Furoate Nasal Spray | Baseline score | 0.79 | Full Range 0 to 3 | Score on a scale |
| Severity of Nasal Congestion at Baseline and Week 12 | Mometasone Furoate Nasal Spray | Score at Week 12 | 0.32 | Full Range 0 to 3 | Score on a scale |
| Severity of Nasal Itching at Baseline and Week 12 | Mometasone Furoate Nasal Spray | Baseline score | 0.74 | Full Range 0 to 3 | Score on a scale |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mometasone Furoate Nasal Spray | 34 | |
| Overall Study | COMPLETED | Mometasone Furoate Nasal Spray | 19 | |
| Overall Study | NOT COMPLETED | Mometasone Furoate Nasal Spray | 15 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mometasone Furoate Nasal Spray | ||
| Total, other adverse events | Mometasone Furoate Nasal Spray | 0 | 34 |
| Total, serious adverse events | Mometasone Furoate Nasal Spray | 0 | 34 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23010795 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01098071
GET https://conductscience.org/api/trials/v1/NCT01098071/registered