Trial · NCT00453063
Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg Once Daily (QD) in the Treatment of Seasonal Allergic Rhinitis (Study P05067)(COMPLETED)
NCT00453063, Phase 3, Completed, Organon and Co; results first posted 2010-05-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg Once Daily (QD) in the Treatment of Seasonal Allergic Rhinitis (Study P05067)(COMPLETED). Trials, record NCT00453063. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00453063
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg Once Daily (QD) in the Treatment of Seasonal Allergic Rhinitis (Study P05067)(COMPLETED)
- NCT number
- NCT00453063
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 426 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- mometasone furoate, Placebo
- First posted
- 2007-03-28
- Last updated
- 2022-02-09
- Results first posted
- 2010-05-17
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 | Baseline and 15 days | TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12. |
| Primary | Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 | Baseline and 15 days | TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 9. |
| Secondary | Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15 | Baseline and 15 days | Nasal congestion was one of the symptoms measured in the TNSS and was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 3. |
| Secondary | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward) | Baseline and 15 days | The RQLQ consisted of 28 items that fell into the following seven domains: activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional. Each of the items was scored from 0 = not troubled to 6 = extremely troubled, and the total of the seven domains was the primary focus of this quality of life evaluation. The best possible score on this scale is 0 and the worst possible score on this scale is 42. The Endpoint was the last post baseline evaluation carried forward and was Day 15 for the majority of the participants. |
| Secondary | Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15 | Baseline and 15 days | Participants were to measure nasal airflow twice daily (in the morning prior to study drug dosing and in the evening) using their PNIF meter. The highest of 3 assessments was to be recorded in the electronic diary. The PNIF meter limits were between 30 and 370 liters/minute. Normal values range between 100 and 150 liters/minute. A positive change from Baseline correlates with improved nasal air flow. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 | Baseline and 15 days | All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation. | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 | Baseline and 15 days | All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15 | Baseline and 15 days | All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Total Score at Endpoint (Last Post Baseline Evaluation Carried Forward) | Baseline and 15 days | The RQLQ tool is only validated in participants greater than or equal to 18 years of age, so it was only administered in this age group. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in AM Peak Nasal Inspiratory Flow (PNIF) Averaged Over Days 2 to 15 | Baseline and 15 days | All randomized participants were to be included in the analysis (intent-to-treat principle). However, subjects with a missing evaluation at a given visit or time point were not included in the analysis for that evaluation. This included participants without a baseline score for a given change-from-baseline evaluation. | liters/minute | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 | Mometasone Furoate Nasal Spray (MFNS) | Baseline TNSS | 9.83 | Standard Deviation 1.56 | units on a scale |
| Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 | Placebo | Baseline TNSS | 9.69 | Standard Deviation 1.56 | units on a scale |
| Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 | Mometasone Furoate Nasal Spray (MFNS) | Change from Baseline in TNSS | -2.36 | Standard Deviation 2.07 | units on a scale |
| Change From Baseline in the Average AM Instantaneous (NOW) Total Nasal Symptom Score (TNSS) Averaged Over Days 2 to 15 | Placebo | Change from Baseline in TNSS | -1.71 | Standard Deviation 2.07 | units on a scale |
| Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 | Mometasone Furoate Nasal Spray (MFNS) | Baseline TOSS | 7.07 | Standard Deviation 1.54 | units on a scale |
| Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 | Placebo | Baseline TOSS | 7.01 | Standard Deviation 1.54 | units on a scale |
| Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 | Mometasone Furoate Nasal Spray (MFNS) | Change from Baseline in TOSS | -1.52 | Standard Deviation 1.59 | units on a scale |
| Change From Baseline in the Average AM Instantaneous (NOW) Total Ocular Symptom Score (TOSS) Averaged Over Days 2 to 15 | Placebo | Change from Baseline in TOSS | -1.36 | Standard Deviation 1.59 | units on a scale |
| Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15 | Mometasone Furoate Nasal Spray (MFNS) | Baseline Nasal Congestion Score | 2.66 | Standard Deviation 0.40 | units on a scale |
| Change From Baseline in AM NOW Nasal Congestion Score Averaged Over Days 2 to 15 | Placebo | Baseline Nasal Congestion Score | 2.64 | Standard Deviation 0.40 | units on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mometasone Furoate Nasal Spray (MFNS) | 211 | |
| Overall Study | STARTED | Placebo | 215 | |
| Overall Study | COMPLETED | Mometasone Furoate Nasal Spray (MFNS) | 208 | |
| Overall Study | COMPLETED | Placebo | 212 | |
| Overall Study | NOT COMPLETED | Mometasone Furoate Nasal Spray (MFNS) | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
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 totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mometasone Furoate Nasal Spray (MFNS) | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Mometasone Furoate Nasal Spray (MFNS) | 0 | 211 |
| Total, other adverse events | Placebo | 0 | 215 |
| Total, serious adverse events | Mometasone Furoate Nasal Spray (MFNS) | 0 | 211 |
| Total, serious adverse events | Placebo | 0 | 215 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21261661 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Mometasone Furoate Nasal Spray (MFNS) vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT00453063
GET https://conductscience.org/api/trials/v1/NCT00453063/registered