Trial · NCT00720382

A Study to Evaluate the Safety and Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis

NCT00720382, 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 Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis. Trials, record NCT00720382. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00720382

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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 Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis
NCT number: NCT00720382
Status: Completed
Phases: Phase 3
Enrollment: 703 participants, actual
Lead sponsor: Meda Pharmaceuticals
Conditions: Perennial Allergic Rhinitis
Interventions: 0.15% azelastine hydrochloride, Mometasone furoate
First posted: 2008-07-22
Last updated: 2015-05-21
Results first posted: 2010-01-15

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline on Direct Visual Nasal Exams to 12 Months	Change from baseline to 12 months	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 irritation 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
Other	Change From Baseline to 12 Months in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older	change from baseline to 12 months	A 28-item RQLQ was completed on Day 1, Month 1, Month 3, Month 6, month 9 and month 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/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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline on Direct Visual Nasal Exams to 12 Months	Change from baseline to 12 months		Participants	NUMBER
OTHER_PRE_SPECIFIED	Change From Baseline to 12 Months in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older	change from baseline to 12 months		Units on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group220

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Change From Baseline on Direct Visual Nasal Exams to 12 Months	Astepro 0.15%	Epistaxis - Day 1	466	Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months	Nasonex®	Epistaxis - Day 1	237	Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months	Astepro 0.15%	None	456	Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months	Nasonex®	None	229	Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months	Astepro 0.15%	Mild	10	Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months	Nasonex®	Mild	8	Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months	Astepro 0.15%	Moderate	0	Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months	Nasonex®	Moderate	0	Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months	Astepro 0.15%	Severe	0	Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months	Nasonex®	Severe	0	Participants

1 to 10 of 220Source ClinicalTrials.gov

See all 220 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Astepro 0.15%	466
Overall Study	STARTED	Nasonex®	237
Overall Study	COMPLETED	Astepro 0.15%	290
Overall Study	COMPLETED	Nasonex®	178
Overall Study	NOT COMPLETED	Astepro 0.15%	176
Overall Study	NOT COMPLETED	Nasonex®	59

Source ClinicalTrials.gov

Adverse events54

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	DYSGEUSIA	Nervous system disorders	Astepro 0.15%	62	466	62
other	DYSGEUSIA	Nervous system disorders	Nasonex®	3	237	3
other	NASAL DISCOMFORT	Respiratory, thoracic and mediastinal disorders	Astepro 0.15%	46	466	46
other	NASAL DISCOMFORT	Respiratory, thoracic and mediastinal disorders	Nasonex®	19	237	19
other	SINUSITIS	Infections and infestations	Astepro 0.15%	44	466	44
other	SINUSITIS	Infections and infestations	Nasonex®	19	237	19
other	UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	Astepro 0.15%	43	466	43
other	UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	Nasonex®	28	237	28
other	EPISTAXIS	Respiratory, thoracic and mediastinal disorders	Astepro 0.15%	43	466	43
other	EPISTAXIS	Respiratory, thoracic and mediastinal disorders	Nasonex®	24	237	24

1 to 10 of 54Source ClinicalTrials.gov

See all 54 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Astepro 0.15%
Total, all-cause mortality	Nasonex®
Total, other adverse events	Astepro 0.15%	349	466
Total, other adverse events	Nasonex®	163	237
Total, serious adverse events	Astepro 0.15%	4	466
Total, serious adverse events	Nasonex®	4	237

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39885937	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 Nasonex®: 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.

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.

GET https://conductscience.org/api/trials/v1/NCT00720382

GET https://conductscience.org/api/trials/v1/NCT00720382/results?page=2

API reference For AI assistants