Trial · NCT00824473
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
NCT00824473, Phase 3, Completed, Meda Pharmaceuticals; results first posted 2010-01-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies. Trials, record NCT00824473. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00824473
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
- NCT number
- NCT00824473
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 506 participants, actual
- Lead sponsor
- Meda Pharmaceuticals
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Placebo, 0.15% azelastine hydrochloride
- First posted
- 2009-01-16
- Last updated
- 2010-02-23
- Results first posted
- 2010-01-28
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)at 14 Days | baseline and 14 days | rTNSS consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. (maximum 12 points per assessment.) Total possible score is 24 per day. Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate. |
| Secondary | Mean Change From Baseline in Instantaneous Total Nasal Symptom Sscore (AM) for the Entire 14-day Study Period Compared to Placebo | baseline to 14 Days | End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous (tNSS) for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous tNSS consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and baseline as a covariate. |
| Secondary | Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | baseline to 14 Days | instantaneous (subjects rate how they feel "right now") total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day. Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate. |
| Secondary | Change From Baseline in 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | baseline to14 Days | reflective and instantaneous symptom scores (itchy eyes, watery eyes and red eyes) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible TOSS score is 9 per day. Least square means was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate. |
| Secondary | Change From Baseline to Visit 4 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older | 14 Days | A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time. Scores for a series of subsclaes are not combined for a total overall score, rather domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items. |
| Secondary | Change From Baseline on Direct Visual Nasal Exams to 14 Days | baseline and 14 days | Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion,Grade 3 = ulceration, Grade 4 = septal perforation |
Source ClinicalTrials.gov
Outcomes6
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 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)at 14 Days | baseline and 14 days | Scores on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Mean Change From Baseline in Instantaneous Total Nasal Symptom Sscore (AM) for the Entire 14-day Study Period Compared to Placebo | baseline to 14 Days | Score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | baseline to 14 Days | scores on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline in 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | baseline to14 Days | Scores on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline to Visit 4 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older | 14 Days | Units on a Scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Change From Baseline on Direct Visual Nasal Exams to 14 Days | baseline and 14 days | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group142
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 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)at 14 Days | Placebo | Baseline symptom score | 18.76 | Standard Deviation 3.301 | Scores on a scale |
| Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)at 14 Days | Astepro 0.15% | Baseline symptom score | 18.48 | Standard Deviation 3.231 | Scores on a scale |
| Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)at 14 Days | Placebo | Overall change from baseline | -2.14 | Standard Deviation 3.696 | Scores on a scale |
| Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)at 14 Days | Astepro 0.15% | Overall change from baseline | -3.57 | Standard Deviation 4.242 | Scores on a scale |
| Mean Change From Baseline in Instantaneous Total Nasal Symptom Sscore (AM) for the Entire 14-day Study Period Compared to Placebo | Placebo | -0.83 | Standard Deviation 1.842 | Score on a scale | |
| Mean Change From Baseline in Instantaneous Total Nasal Symptom Sscore (AM) for the Entire 14-day Study Period Compared to Placebo | Astepro 0.15% | -1.43 | Standard Deviation 2.088 | Score on a scale | |
| Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | Placebo | Baseline symptom score | 17.63 | Standard Deviation 3.906 | scores on a scale |
| Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | Astepro 0.15% | Baseline symptom score | 17.43 | Standard Deviation 3.665 | scores on a scale |
| Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | Placebo | Overall change from baseline | -1.73 | Standard Deviation 3.669 | scores on a scale |
| Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined) | Astepro 0.15% | Overall change from baseline | -3.12 | Standard Deviation 4.099 | scores on a scale |
1 to 10 of 142Source ClinicalTrials.gov
See all 142 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 255 | |
| Overall Study | STARTED | Astepro 0.15% | 251 | |
| Overall Study | COMPLETED | Placebo | 240 | |
| Overall Study | COMPLETED | Astepro 0.15% | 238 | |
| Overall Study | NOT COMPLETED | Placebo | 15 | |
| Overall Study | NOT COMPLETED | Astepro 0.15% | 13 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 255 | 0 |
| other | Nasal discomfort | Respiratory, thoracic and mediastinal disorders | Astepro 0.15% | 9 | 251 | 9 |
| other | Dysgeusia | Nervous system disorders | Placebo | 2 | 255 | 2 |
| other | Dysgeusia | Nervous system disorders | Astepro 0.15% | 6 | 251 | 6 |
| other | Headache | Nervous system disorders | Placebo | 0 | 255 | 0 |
| other | Headache | Nervous system disorders | Astepro 0.15% | 5 | 251 | 5 |
| other | Sneezing | Respiratory, thoracic and mediastinal disorders | Placebo | 0 | 255 | 0 |
| other | Sneezing | Respiratory, thoracic and mediastinal disorders | Astepro 0.15% | 5 | 251 | 5 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Astepro 0.15% | ||
| Total, other adverse events | Placebo | 2 | 255 |
| Total, other adverse events | Astepro 0.15% | 25 | 251 |
| Total, serious adverse events | Placebo | 0 | 255 |
| Total, serious adverse events | Astepro 0.15% | 0 | 251 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22287431 | DERIVED |
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 |
|---|
| Astepro 0.15% 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/NCT00824473
GET https://conductscience.org/api/trials/v1/NCT00824473/results?page=2