Trial Outcomes & Findings for A Study to Evaluate the Safety and Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis (NCT NCT00720382)

NCT ID: NCT00720382

Last Updated: 2015-05-21

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

703 participants

Primary outcome timeframe

Change from baseline to 12 months

Results posted on

2015-05-21

Participant Flow

First observation: 09 MAR 2007 Last observation: 20 JUN 2008

Subjects participated in a 7 day screening period to identify appropriate subjects based on symptom scores.

Participant milestones

Participant milestones
Measure	Astepro 0.15% 0.15% azelastine hydrochloride 1644 mcg	Nasonex® Mometasone furoate 200 mcg
Overall Study STARTED	466	237
Overall Study COMPLETED	290	178
Overall Study NOT COMPLETED	176	59

Reasons for withdrawal

Reasons for withdrawal
Measure	Astepro 0.15% 0.15% azelastine hydrochloride 1644 mcg	Nasonex® Mometasone furoate 200 mcg
Overall Study Adverse Event	54	17
Overall Study Lack of Efficacy	18	7
Overall Study Non-Compliance	15	5
Overall Study Withdrawal by Subject	47	11
Overall Study Lost to Follow-up	28	14
Overall Study administrative	14	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Astepro 0.15% n=466 Participants 0.15% azelastine hydrochloride 1644 mcg	Nasonex® n=237 Participants Mometasone furoate 200 mcg	Total n=703 Participants Total of all reporting groups
Age, Categorical <=18 years	37 Participants n=5 Participants	18 Participants n=7 Participants	55 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	410 Participants n=5 Participants	211 Participants n=7 Participants	621 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants	8 Participants n=7 Participants	27 Participants n=5 Participants
Age, Continuous	39.3 years STANDARD_DEVIATION 14.54 • n=5 Participants	39.1 years STANDARD_DEVIATION 14.61 • n=7 Participants	39.2 years STANDARD_DEVIATION 14.55 • n=5 Participants
Sex: Female, Male Female	310 Participants n=5 Participants	175 Participants n=7 Participants	485 Participants n=5 Participants
Sex: Female, Male Male	156 Participants n=5 Participants	62 Participants n=7 Participants	218 Participants n=5 Participants
Region of Enrollment United States	466 participants n=5 Participants	237 participants n=7 Participants	703 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to 12 months

Outcome measures

Outcome measures
Measure	Astepro 0.15% n=466 Participants 0.15% azelastine hydrochloride 1644 mcg	Nasonex® n=237 Participants Mometasone furoate 200 mcg
Change From Baseline on Direct Visual Nasal Exams to 12 Months None	433 Participants	206 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Mild	9 Participants	12 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Moderate	1 Participants	2 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Severe	0 Participants	0 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Crusting of Mucosa - Month 12/ET	402 Participants	220 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Mucosal Erythema - Month 12/ET	402 Participants	220 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Mucosal Bleeding - Day 1	466 Participants	237 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Mucosal Edema - Month 12/ET	402 Participants	220 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Epistaxis - Day 1	466 Participants	237 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Epistaxis - Month 12/ET	402 Participants	220 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Nasal Irritation - Day 1	466 Participants	237 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Grade 1A	22 Participants	17 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Nasal Discharge - Day 1	466 Participants	237 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Nasal Discharge - Month 12/ET	402 Participants	220 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Mucosal Erythema - Day 1	466 Participants	237 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Lymphadenopathy - Month 12/ET	402 Participants	220 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Mucosal Edema - Day 1	466 Participants	237 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Mucosal Bleeding - Month 12/ET	402 Participants	220 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Crusting of Mucosa - Day 1	466 Participants	237 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Grade 1B	4 Participants	2 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Grade 2	2 Participants	0 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Grade 3	0 Participants	0 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Grade 4	0 Participants	1 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Nasal Irritation - Month 12/ET	402 Participants	220 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Conjunctival injection - Day 1	466 Participants	237 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Conjunctival injection - Month 12/ET	402 Participants	220 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Erythematous TM - Day 1	466 Participants	236 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Erythematous TM - Month 12/ET	402 Participants	220 Participants
Change From Baseline on Direct Visual Nasal Exams to 12 Months Lymphadenophthy-Day 1	465 Participants	237 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Astepro 0.15% n=466 Participants 0.15% azelastine hydrochloride 1644 mcg	Nasonex® n=237 Participants Mometasone furoate 200 mcg
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 Overall Score Baseline	2.78 Units on a scale Standard Deviation 1.227	2.75 Units on a scale Standard Deviation 1.191
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 Month 1	-0.97 Units on a scale Standard Deviation 1.201	-0.97 Units on a scale Standard Deviation 1.245
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 Month 3	-1.15 Units on a scale Standard Deviation 1.256	-1.27 Units on a scale Standard Deviation 1.379
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 Month 6	-1.13 Units on a scale Standard Deviation 1.236	-1.29 Units on a scale Standard Deviation 1.372
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 Month 9	-1.17 Units on a scale Standard Deviation 1.219	-1.31 Units on a scale Standard Deviation 1.425
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 Month 12/ET	-0.90 Units on a scale Standard Deviation 1.302	-1.11 Units on a scale Standard Deviation 1.364

Adverse Events

Astepro 0.15%

Serious events: 4 serious events

Other events: 349 other events

Deaths: 0 deaths

Nasonex®

Serious events: 4 serious events

Other events: 163 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Astepro 0.15% n=466 participants at risk 0.15% azelastine hydrochloride 1644 mcg	Nasonex® n=237 participants at risk Mometasone furoate 200 mcg
Cardiac disorders ANGINA PECTORIS	0.21% 1/466 • Number of events 1 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	0.00% 0/237 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Cardiac disorders CORONARY ARTERY DISEASE	0.21% 1/466 • Number of events 1 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	0.00% 0/237 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Hepatobiliary disorders CHOLECYSTITIS	0.00% 0/466 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	0.42% 1/237 • Number of events 1 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Infections and infestations APPENDICITIS	0.21% 1/466 • Number of events 1 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	0.00% 0/237 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Infections and infestations BRONCHITIS	0.21% 1/466 • Number of events 1 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	0.00% 0/237 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Infections and infestations CELLULITIS	0.00% 0/466 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	0.42% 1/237 • Number of events 1 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLON CANCER	0.00% 0/466 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	0.42% 1/237 • Number of events 1 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Reproductive system and breast disorders CYSTOCELE	0.00% 0/466 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	0.42% 1/237 • Number of events 1 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.21% 1/466 • Number of events 1 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	0.00% 0/237 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.

Other adverse events

Additional Information

William Wheeler, PhD

Meda Pharmaceuticals

Phone: 732-564-2393

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee For multicenter studies, joint publication is required to assure that the initial publication is based on all data from all sites and investigators participating in these studies agree not to present data gathered individually or by subgroup centers before the initial publication unless jointly agreed by all other investigators and the sponsor. Authorship will be determined by mutual agreement.
Publication restrictions are in place

Restriction type: OTHER

Measure	Astepro 0.15% n=466 participants at risk 0.15% azelastine hydrochloride 1644 mcg	Nasonex® n=237 participants at risk Mometasone furoate 200 mcg
Nervous system disorders DYSGEUSIA	13.3% 62/466 • Number of events 62 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	1.3% 3/237 • Number of events 3 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Respiratory, thoracic and mediastinal disorders NASAL DISCOMFORT	9.9% 46/466 • Number of events 46 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	8.0% 19/237 • Number of events 19 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Infections and infestations SINUSITIS	9.4% 44/466 • Number of events 44 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	8.0% 19/237 • Number of events 19 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	9.2% 43/466 • Number of events 43 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	11.8% 28/237 • Number of events 28 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	9.2% 43/466 • Number of events 43 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	10.1% 24/237 • Number of events 24 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Infections and infestations NASOPHARYNGITIS	9.2% 43/466 • Number of events 43 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	8.4% 20/237 • Number of events 20 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Nervous system disorders HEADACHE	8.8% 41/466 • Number of events 41 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	12.7% 30/237 • Number of events 30 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Respiratory, thoracic and mediastinal disorders PHARYNGOLARYNGEAL PAIN	4.7% 22/466 • Number of events 22 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	5.9% 14/237 • Number of events 14 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Infections and infestations BRONCHITIS	4.1% 19/466 • Number of events 19 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	2.5% 6/237 • Number of events 6 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
General disorders FATIGUE	4.1% 19/466 • Number of events 19 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	0.84% 2/237 • Number of events 2 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Nervous system disorders SOMNOLENCE	3.6% 17/466 • Number of events 17 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	0.42% 1/237 • Number of events 1 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Musculoskeletal and connective tissue disorders BACK PAIN	3.4% 16/466 • Number of events 16 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	2.1% 5/237 • Number of events 5 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Respiratory, thoracic and mediastinal disorders COUGH	3.2% 15/466 • Number of events 15 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	5.1% 12/237 • Number of events 12 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Infections and infestations INFLUENZA	3.2% 15/466 • Number of events 15 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	3.8% 9/237 • Number of events 9 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Nervous system disorders SINUS HEADACHE	3.2% 15/466 • Number of events 15 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	1.7% 4/237 • Number of events 4 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Respiratory, thoracic and mediastinal disorders SNEEZING	3.0% 14/466 • Number of events 14 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	0.00% 0/237 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
General disorders MUCOSAL EROSION	2.8% 13/466 • Number of events 13 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	2.5% 6/237 • Number of events 6 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.
Respiratory, thoracic and mediastinal disorders RHINITIS ALLERGIC	2.4% 11/466 • Number of events 11 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.	1.7% 4/237 • Number of events 4 • 12 Months Ae's greater than 2% in MP03-36 (Astepro 0.15%). Any significant findings found on the nasal exams were reported as AE's and would be found here.