Trial · NCT00783432
Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis
NCT00783432, Phase 3, Completed, Meda Pharmaceuticals; results first posted 2009-10-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis. Trials, record NCT00783432. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00783432
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis
- NCT number
- NCT00783432
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 862 participants, actual
- Lead sponsor
- Meda Pharmaceuticals
- Conditions
- Chronic Allergic Rhinitis, Nonallergic Rhinitis
- Interventions
- Astepro Nasal Spray (0.1% azelastine hydrochloride), Astelin Nasal Spray (0.1% azelastine hydrochloride)
- First posted
- 2008-10-31
- Last updated
- 2009-10-06
- Results first posted
- 2009-10-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Reporting Adverse Events | 12 months | An AE can be any unfavorable and unintended sign,symptom, or disease temporally associated with the use of this investigational product, whether or not considered related to the investigational product. An AE is any untoward medical occurrence in a subject which does not necessarily have a causal relationship with this treatment. |
| Primary | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | baseline and 12 months/ET | Examination of head and neck(scale: 0, 1+=Mild, 2+=Moderate, 3++Severe) for mucosal edema, nasal discharge, mucosal erythema, mucosal bleeding, mucosal ulcerations, crusting of mucosa, conjunctiva, tympanic membranes, lymph nodes of head and neck. Direct visual nasal examination (scale: None, Grade 2, Grade 3, and Grade 4) for epistaxis,ulceration and pain. |
| Secondary | Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination. | baseline, months 1,3,6,9 and 12/or early termination | 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. Total possible RQLQ score is 42 at any given evaluation. Scale of how troubled is:0=Not,2=Somewhat,3=Moderate,4=Quite a bit,5=Very,6 Extremely. Only change from baseline to month 12 primary analysis is provided. |
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 | Number of Participants Reporting Adverse Events | 12 months | Number of participants for analysis was based on a safety population that included any subject who received at least one dose of study medication. | Participants | NUMBER |
| PRIMARY | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | baseline and 12 months/ET | Participants | NUMBER | |
| SECONDARY | Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination. | baseline, months 1,3,6,9 and 12/or early termination | Analysis is based on safety population, which is defined as subjects who took at least one dose of study medication. | Units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group254
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Reporting Adverse Events | Astepro Nasal Spray | 207 | Participants | ||
| Number of Participants Reporting Adverse Events | Astelin Nasal Spray | 211 | Participants | ||
| Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Astepro Nasal Spray | Conjunctiva: Total baseline | 428 | Participants | |
| Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Astelin Nasal Spray | Conjunctiva: Total baseline | 430 | Participants | |
| Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Astepro Nasal Spray | Conjunctiva: baseline-None | 264 | Participants | |
| Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Astelin Nasal Spray | Conjunctiva: baseline-None | 254 | Participants | |
| Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Astepro Nasal Spray | Conjunctiva: baseline-Mild (1+) | 99 | Participants | |
| Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Astelin Nasal Spray | Conjunctiva: baseline-Mild (1+) | 109 | Participants | |
| Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Astepro Nasal Spray | Conjunctiva: baseline-Moderate (2+) | 53 | Participants | |
| Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Astelin Nasal Spray | Conjunctiva: baseline-Moderate (2+) | 54 | Participants |
1 to 10 of 254Source ClinicalTrials.gov
See all 254 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Astepro Nasal Spray | 430 | |
| Overall Study | STARTED | Astelin Nasal Spray | 432 | |
| Overall Study | COMPLETED | Astepro Nasal Spray | 345 | |
| Overall Study | COMPLETED | Astelin Nasal Spray | 354 | |
| Overall Study | NOT COMPLETED | Astepro Nasal Spray | 85 | |
| Overall Study | NOT COMPLETED | Astelin Nasal Spray | 78 |
Source ClinicalTrials.gov
Adverse events52
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 | Headache | Nervous system disorders | Astepro Nasal Spray | 49 | 428 | 49 |
| other | Headache | Nervous system disorders | Astelin Nasal Spray | 43 | 430 | 43 |
| other | Nasopharyngitis | Infections and infestations | Astepro Nasal Spray | 34 | 428 | 34 |
| other | Nasopharyngitis | Infections and infestations | Astelin Nasal Spray | 25 | 430 | 25 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Astepro Nasal Spray | 29 | 428 | 29 |
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Astelin Nasal Spray | 32 | 430 | 32 |
| other | Dysgeusia | Nervous system disorders | Astepro Nasal Spray | 28 | 428 | 28 |
| other | Dysgeusia | Nervous system disorders | Astelin Nasal Spray | 32 | 430 | 32 |
| other | Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | Astepro Nasal Spray | 23 | 428 | 23 |
| other | Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | Astelin Nasal Spray | 14 | 430 | 14 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Astepro Nasal Spray | ||
| Total, all-cause mortality | Astelin Nasal Spray | ||
| Total, other adverse events | Astepro Nasal Spray | 163 | |
| Total, other adverse events | Astelin Nasal Spray | 146 | |
| Total, serious adverse events | Astepro Nasal Spray | 7 | |
| Total, serious adverse events | Astelin Nasal Spray | 10 |
Source ClinicalTrials.gov
Papers0
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Astepro Nasal Spray vs Astelin Nasal Spray: Number of Participants Reporting 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/NCT00783432
GET https://conductscience.org/api/trials/v1/NCT00783432/results?page=2