Trial · NCT00712920

A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergies

NCT00712920, Phase 3, Completed, Meda Pharmaceuticals; results first posted 2010-01-15

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 Perennial Allergies. Trials, record NCT00712920. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00712920

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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 Perennial Allergies
NCT number: NCT00712920
Status: Completed
Phases: Phase 3
Enrollment: 581 participants, actual
Lead sponsor: Meda Pharmaceuticals
Conditions: Perennial Allergic Rhinitis
Interventions: 0.15% azelastine hydrochloride, 0.1% azelastine hydrochloride, Placebo
First posted: 2008-07-10
Last updated: 2011-06-08
Results first posted: 2010-01-15
Limitations and caveats: Standard deviations for primary endpoint are not available.

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 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.	baseline and 28 days	Reflective 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 (LS Mean) 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 Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days	baseline and 28 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.
Secondary	Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days	baseline and 28 days	Reflective secondary symptom complex scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) 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 SSCS score is 24 per day.
Secondary	Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days	baseline and 28 Days	A 28-item RQLQ was completed on Day 1 and Day 28 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. 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 and 28 Days	baseline and 28 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

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 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.	baseline and 28 days	ITT	Scores on a Scale	NUMBER
SECONDARY	Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days	baseline and 28 days	ITT	Scores on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days	baseline and 28 days	ITT	Scores on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days	baseline and 28 Days	ITT	Units on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline on Direct Visual Nasal Exams and 28 Days	baseline and 28 days	ITT	Participants	NUMBER

Source ClinicalTrials.gov

Results by group276

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 (AM and PM Combined) at 28 Days.	Placebo	Baseline Least Squares Mean Symptom Score	14.7	0.0	Scores on a Scale
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.	Astepro 0.1%	Baseline Least Squares Mean Symptom Score	15.5	0.0	Scores on a Scale
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.	Astepro 0.15%	Baseline Least Squares Mean Symptom Score	15.8	0.0	Scores on a Scale
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.	Placebo	Change from baseline LS Mean symptom score	-3.1	0.0	Scores on a Scale
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.	Astepro 0.1%	Change from baseline LS Mean symptom score	-3.8	0.0	Scores on a Scale
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.	Astepro 0.15%	Change from baseline LS Mean symptom score	-4.0	0.0	Scores on a Scale
Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days	Placebo	Baseline Symptom score	13.28	Standard Deviation 4.614	Scores on a Scale
Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days	Astepro 0.1%	Baseline Symptom score	13.91	Standard Deviation 4.616	Scores on a Scale
Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days	Astepro 0.15%	Baseline Symptom score	14.30	Standard Deviation 4.572	Scores on a Scale
Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days	Placebo	Overall Change from baseline	-2.72	Standard Deviation 4.129	Scores on a Scale

1 to 10 of 276Source ClinicalTrials.gov

See all 276 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	192
Overall Study	STARTED	Astepro 0.1%	197
Overall Study	STARTED	Astepro 0.15%	192
Overall Study	COMPLETED	Placebo	175
Overall Study	COMPLETED	Astepro 0.1%	180
Overall Study	COMPLETED	Astepro 0.15%	180
Overall Study	NOT COMPLETED	Placebo	17
Overall Study	NOT COMPLETED	Astepro 0.1%	17
Overall Study	NOT COMPLETED	Astepro 0.15%	12

Source ClinicalTrials.gov

Adverse events18

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	7	192	7
other	Nasal Discomfort	Respiratory, thoracic and mediastinal disorders	Astepro 0.1%	7	194	7
other	Nasal Discomfort	Respiratory, thoracic and mediastinal disorders	Astepro 0.15%	13	192	13
other	Dysgesusia	Nervous system disorders	Placebo	1	192	1
other	Dysgesusia	Nervous system disorders	Astepro 0.1%	11	194	11
other	Dysgesusia	Nervous system disorders	Astepro 0.15%	9	192	9
other	Headache	Nervous system disorders	Placebo	6	192	6
other	Headache	Nervous system disorders	Astepro 0.1%	4	194	4
other	Headache	Nervous system disorders	Astepro 0.15%	1	192	1
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	Placebo	3	192	3

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Astepro 0.1%
Total, all-cause mortality	Astepro 0.15%
Total, other adverse events	Placebo	21	192
Total, other adverse events	Astepro 0.1%	27	194
Total, other adverse events	Astepro 0.15%	32	192
Total, serious adverse events	Placebo	0	192
Total, serious adverse events	Astepro 0.1%	0	194
Total, serious adverse events	Astepro 0.15%	0	192

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37920410	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 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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