Perennial Allergic Rhinitis
Conditions
Brief summary
The purpose of this study is to determine if one allergy treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.
Interventions
1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM
DRUGMometasone furoate
200 mcg (50 mcg/spray) 2 sprays per nostril Once a day (AM)
Sponsors
Meda Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female patients 12 years and older with a compatible history greater than or equal to 1 year of rhinitis due to perennial allergies. * Must be willing and able to provide informed consent and to participate in all study procedures * Must be in generally good health * Positive skin test to a prevalent perennial allergen
Exclusion criteria
* On nasal examination, the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation * Use of any investigational drug within 30 days of the first visit * Any nasal surgery or sinus surgery within the previous year * Presence of any hypersensitivity to drugs similar to azelastine or mometasone furoate and to either sorbital or sucralose * Women who are pregnant or nursing * Women who are not using an acceptable method of birth control * Nasal Diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities. * Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with investigator. * Patients with Arrythmia * Patients with know history of alcohol and drug abuse * Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of the study. * Use of medications that could affect the study results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
First observation: 09 MAR 2007 Last observation: 20 JUN 2008
Pre-assignment details
Subjects participated in a 7 day screening period to identify appropriate subjects based on symptom scores.
Participants by arm
| Arm | Count |
|---|---|
| Astepro 0.15% 0.15% azelastine hydrochloride 1644 mcg | 466 |
| Nasonex® Mometasone furoate 200 mcg | 237 |
| Total | 703 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | administrative | 14 | 5 |
| Overall Study | Adverse Event | 54 | 17 |
| Overall Study | Lack of Efficacy | 18 | 7 |
| Overall Study | Lost to Follow-up | 28 | 14 |
| Overall Study | Non-Compliance | 15 | 5 |
| Overall Study | Withdrawal by Subject | 47 | 11 |
Baseline characteristics
| Characteristic | Nasonex® | Astepro 0.15% | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 18 Participants | 37 Participants | 55 Participants |
| Age, Categorical >=65 years | 8 Participants | 19 Participants | 27 Participants |
| Age, Categorical Between 18 and 65 years | 211 Participants | 410 Participants | 621 Participants |
| Age, Continuous | 39.1 years STANDARD_DEVIATION 14.61 | 39.3 years STANDARD_DEVIATION 14.54 | 39.2 years STANDARD_DEVIATION 14.55 |
| Region of Enrollment United States | 237 participants | 466 participants | 703 participants |
| Sex: Female, Male Female | 175 Participants | 310 Participants | 485 Participants |
| Sex: Female, Male Male | 62 Participants | 156 Participants | 218 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 349 / 466 | 163 / 237 |
| serious Total, serious adverse events | 4 / 466 | 4 / 237 |
Outcome results
Primary
Change From Baseline on Direct Visual Nasal Exams 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
Time frame: Change from baseline to 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 425 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 340 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mucosal Edema - Day 1 | 466 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 92 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 100 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 162 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Grade 1A | 37 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 181 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 24 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 31 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 456 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mucosal Edema - Month 12/ET | 402 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 2 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 101 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Grade 1B | 2 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 157 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Conjunctival injection - Month 12/ET | 402 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 129 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Epistaxis - Month 12/ET | 402 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 15 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 336 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Nasal Discharge - Day 1 | 466 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Grade 2 | 2 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 178 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 8 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 202 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 392 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 78 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 2 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 8 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Grade 3 | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Nasal Discharge - Month 12/ET | 402 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Erythematous TM - Day 1 | 466 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 182 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 387 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 163 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 443 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 53 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Grade 4 | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 4 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 21 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mucosal Erythema - Day 1 | 466 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 10 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 258 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 2 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 153 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Nasal Irritation - Month 12/ET | 402 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 54 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 15 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mucosal Erythema - Month 12/ET | 402 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Erythematous TM - Month 12/ET | 402 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 254 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 374 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 114 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Epistaxis - Day 1 | 466 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 31 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 9 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 3 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Grade 1A | 22 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mucosal Bleeding - Day 1 | 466 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 451 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 15 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Grade 1B | 4 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Lymphadenophthy-Day 1 | 465 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mucosal Bleeding - Month 12/ET | 402 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 384 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 433 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 17 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Grade 2 | 2 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 1 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 30 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Crusting of Mucosa - Day 1 | 466 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 2 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 412 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Grade 3 | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 46 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 8 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Nasal Irritation - Day 1 | 466 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Lymphadenopathy - Month 12/ET | 402 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Crusting of Mucosa - Month 12/ET | 402 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Grade 4 | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 373 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 388 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 20 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 56 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 9 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 13 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 0 Participants |
| Astepro 0.15% | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Conjunctival injection - Day 1 | 466 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 0 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 31 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Epistaxis - Day 1 | 237 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 229 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 8 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 0 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 0 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Epistaxis - Month 12/ET | 220 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 213 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 7 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 0 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Nasal Irritation - Day 1 | 237 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 217 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Grade 1A | 17 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Grade 1B | 3 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Grade 2 | 0 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Grade 3 | 0 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Grade 4 | 0 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Nasal Irritation - Month 12/ET | 220 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 200 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Grade 1A | 17 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Grade 1B | 2 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Grade 2 | 0 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Grade 3 | 0 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Grade 4 | 1 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Conjunctival injection - Day 1 | 237 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 164 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 58 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 14 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 1 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Conjunctival injection - Month 12/ET | 220 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 182 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 7 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 0 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Erythematous TM - Day 1 | 236 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 226 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 8 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 1 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 1 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Erythematous TM - Month 12/ET | 220 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 206 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 12 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 2 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 0 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Lymphadenophthy-Day 1 | 237 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 225 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 12 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 0 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 0 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Lymphadenopathy - Month 12/ET | 220 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 210 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 9 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 1 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 0 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mucosal Edema - Day 1 | 237 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 42 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 87 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 96 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 12 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mucosal Edema - Month 12/ET | 220 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 54 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 94 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 66 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 6 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Nasal Discharge - Day 1 | 237 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 89 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 110 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 33 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 5 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Nasal Discharge - Month 12/ET | 220 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 90 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 107 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 22 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 1 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mucosal Erythema - Day 1 | 237 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 145 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 67 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 21 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 4 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mucosal Erythema - Month 12/ET | 220 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 142 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 58 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 20 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 0 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mucosal Bleeding - Day 1 | 237 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 224 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 11 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 1 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 1 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mucosal Bleeding - Month 12/ET | 220 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 208 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 11 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 1 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 0 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Crusting of Mucosa - Day 1 | 237 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 215 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 20 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 1 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 1 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Crusting of Mucosa - Month 12/ET | 220 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | None | 197 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Mild | 22 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Moderate | 1 Participants |
| Nasonex® | Change From Baseline on Direct Visual Nasal Exams to 12 Months | Severe | 0 Participants |
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
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.
Time frame: change from baseline to 12 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Astepro 0.15% | 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 |
| Astepro 0.15% | 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 |
| Astepro 0.15% | 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 |
| Astepro 0.15% | 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 |
| Astepro 0.15% | 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 |
| Astepro 0.15% | 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 |
| Nasonex® | 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 | -1.31 Units on a scale | Standard Deviation 1.425 |
| Nasonex® | 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 | 2.75 Units on a scale | Standard Deviation 1.191 |
| Nasonex® | 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 | -1.29 Units on a scale | Standard Deviation 1.372 |
| Nasonex® | 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 1.245 |
| Nasonex® | 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 | -1.11 Units on a scale | Standard Deviation 1.364 |
| Nasonex® | 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 | -1.27 Units on a scale | Standard Deviation 1.379 |
Comparison: Overall baseline scorep-value: 0.783ANCOVA
Comparison: Change from baseline to Month 1p-value: 0.971ANCOVA
Comparison: Change from baseline to Month 3p-value: 0.206ANCOVA
Comparison: Change from baseline to Month 6p-value: 0.111ANCOVA
Comparison: Change from baseline to Month 9p-value: 0.181ANCOVA
Comparison: Change from Baseline to Month 12/Early Termp-value: 0.037ANCOVA