Trial · NCT00883168
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
NCT00883168, Phase 3, Completed, Meda Pharmaceuticals; results first posted 2012-09-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies. Trials, record NCT00883168. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00883168
On this page
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
- NCT00883168
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,791 participants, actual
- Lead sponsor
- Meda Pharmaceuticals
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Placebo, azelastineHcl, fluticasone propionate, azelastine Hcl/fluticasone propionate
- First posted
- 2009-04-17
- Last updated
- 2013-06-24
- Results first posted
- 2012-09-07
Source ClinicalTrials.gov
Registered outcomes3
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) | day 1 to day 14 | change from baseline in 12-hour reflective total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.An greater negative value is suggestive of improvement. |
| Secondary | Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS) | day 1 to day 14 | change from baseline in 12-hour instantaneous total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.A greater negative score is suggestive of improved condition. |
| Secondary | Change From Baseline in Adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | day 1 to day 14 | adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement. An increased negative number is suggestive of improvement. |
Source ClinicalTrials.gov
Outcomes3
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) | day 1 to day 14 | Intent to Treat (ITT) population includes all subjects who had at least one post baseline dose efficacy evaluation | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS) | day 1 to day 14 | Intent to Treat (ITT) population includes all subjects who received at least one post baseline efficacy evaluation | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | day 1 to day 14 | Intent to treat (ITT)population includes all subjects(18 years or older) who had at least one post baseline efficacy evaluation | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group12
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) | MP29-02 | -5.5 | Standard Deviation 5.2 | units on a scale | |
| Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS) | Azelastine Hcl | -4.8 | Standard Deviation 4.8 | units on a scale | |
| Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS) | Fluticasone Propionate | -4.9 | Standard Deviation 4.7 | units on a scale | |
| Change From Baseline in 12 Hour Reflective Total Nasal Symptom Score (rTNSS) | Placebo | -3.4 | Standard Deviation 4.3 | units on a scale | |
| Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS) | MP29-02 | -5.0 | Standard Deviation 5.3 | units on a scale | |
| Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS) | Azelastine Hcl | -4.3 | Standard Deviation 4.9 | units on a scale | |
| Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS) | Fluticasone Propionate | -4.7 | Standard Deviation 4.9 | units on a scale | |
| Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS) | Placebo | -3.1 | Standard Deviation 4.4 | units on a scale | |
| Change From Baseline in Adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | MP29-02 | -1.6 | Standard Deviation 1.3 | units on a scale | |
| Change From Baseline in Adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) | Azelastine Hcl | -1.4 | Standard Deviation 1.3 | units on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MP29-02 | 448 | |
| Overall Study | STARTED | Azelastine Hcl | 445 | |
| Overall Study | STARTED | Fluticasone Propionate | 450 | |
| Overall Study | STARTED | Placebo | 448 | |
| Overall Study | COMPLETED | MP29-02 | 434 | |
| Overall Study | COMPLETED | Azelastine Hcl | 430 | |
| Overall Study | COMPLETED | Fluticasone Propionate | 431 | |
| Overall Study | COMPLETED | Placebo | 433 | |
| Overall Study | NOT COMPLETED | MP29-02 | 14 | |
| Overall Study | NOT COMPLETED | Azelastine Hcl | 15 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events40
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 | dysgusia | Gastrointestinal disorders | MP29-02 | 21 | 448 | 21 |
| other | dysgusia | Gastrointestinal disorders | Azelastine Hcl | 23 | 449 | 23 |
| other | dysgusia | Gastrointestinal disorders | Fluticasone Propionate | 1 | 450 | 1 |
| other | dysgusia | Gastrointestinal disorders | Placebo | 0 | 451 | 0 |
| other | headache | Nervous system disorders | MP29-02 | 10 | 448 | 10 |
| other | headache | Nervous system disorders | Azelastine Hcl | 14 | 449 | 14 |
| other | headache | Nervous system disorders | Fluticasone Propionate | 8 | 450 | 8 |
| other | headache | Nervous system disorders | Placebo | 4 | 451 | 4 |
| other | epistaxis | Respiratory, thoracic and mediastinal disorders | MP29-02 | 10 | 448 | 10 |
| other | epistaxis | Respiratory, thoracic and mediastinal disorders | Azelastine Hcl | 6 | 449 | 6 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MP29-02 | ||
| Total, all-cause mortality | Azelastine Hcl | ||
| Total, all-cause mortality | Fluticasone Propionate | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | MP29-02 | 57 | 448 |
| Total, other adverse events | Azelastine Hcl | 47 | 449 |
| Total, other adverse events | Fluticasone Propionate | 32 | 450 |
| Total, other adverse events | Placebo | 26 | 451 |
| Total, serious adverse events | MP29-02 | 1 | 448 |
| Total, serious adverse events | Azelastine Hcl | 0 | 449 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00883168
GET https://conductscience.org/api/trials/v1/NCT00883168/events?page=2