Chronic Allergic Rhinitis, Nonallergic Rhinitis
Conditions
Brief summary
The purpose of this study is to determine if Astepro Nasal Spray (0.1% azelastine hydrochloride) is as safe as Astelin Nasal Spray (0.1% azelastine hydrochloride)
Interventions
DRUGAstepro Nasal Spray (0.1% azelastine hydrochloride)
548 mcg (2 sprays per nostril) twice a day
DRUGAstelin Nasal Spray (0.1% azelastine hydrochloride)
548 mcg (2 sprays per nostril) twice a day
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
1. Male and female patients 12 years of age and older with an established history (\> 1 year) of rhinitis due to perennial allergies, non-allergic triggers or vasomotor rhinitis (VMR). 2. Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent 3. Willing and able to comply with the study requirements, including daily use of medication for a one year period, even if symptoms are not bothersome. 4. General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor's medical officer 5. Patients receiving immunotherapy (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit (adjustments to regimen following a brief period of missed injections does not preclude participation)
Exclusion criteria
1. The use of any investigational drug within 30 days prior to screening. No other investigational products are permitted for use during the conduct of this study 2. Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener) 3. Women who are pregnant or nursing 4. Women of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception. Female patients must practice an acceptable contraceptive technique for 30 days before randomization and agree to continue its use during treatment and for 30 days after the last dose of study drug. Oral, intrauterine, implantable, injectable contraceptives, or a double barrier form of contraception are acceptable and the medication including dose, device or method must have been stable for at least 30 days before the first dose of study drug. 5. Nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis,rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities 6. Patients with asthma (with the exception of mild, intermittent asthma) or other significant pulmonary disease such as Chronic Obstructive Pulmonary Disease 7. Patients with a known history of alcohol or drug abuse 8. Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of study 9. Clinically relevant abnormal history and/or physical findings which, in the opinion of the investigator or sponsor, would interfere with the objectives of the study or that may preclude compliance with the study procedures 10. Study site staff, immediate relatives of study site staff, or other individuals who would have access to the clinical study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
First observation 24 July 2006 and last observation 28 Dec 2007
Pre-assignment details
Subjects participated in a one-week screening period to identify appropriate subjects based on symptom scores
Participants by arm
| Arm | Count |
|---|---|
| Astepro Nasal Spray (0.1% azelastine hydrochloride) | 428 |
| Astelin Nasal Spray (0.1% azelastine hydrochloride) | 430 |
| Total | 858 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 22 | 17 |
| Overall Study | Lack of Efficacy | 20 | 21 |
| Overall Study | Lost to Follow-up | 11 | 6 |
| Overall Study | Protocol Violation | 6 | 9 |
| Overall Study | subject moved | 3 | 5 |
| Overall Study | Withdrawal by Subject | 23 | 20 |
Baseline characteristics
| Characteristic | Total | Astelin Nasal Spray | Astepro Nasal Spray |
|---|---|---|---|
| Age, Categorical <=18 years | 21 Participants | 10 Participants | 11 Participants |
| Age, Categorical >=65 years | 57 Participants | 29 Participants | 28 Participants |
| Age, Categorical Between 18 and 65 years | 780 Participants | 391 Participants | 389 Participants |
| Age Continuous | 41.2 years STANDARD_DEVIATION 15.03 | 41.3 years STANDARD_DEVIATION 15.12 | 41.2 years STANDARD_DEVIATION 14.95 |
| Duration of Rhinitis | 10.9 years STANDARD_DEVIATION 10.95 | 11.3 years STANDARD_DEVIATION 10.85 | 10.5 years STANDARD_DEVIATION 11.04 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 24 Participants | 16 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) White | 815 Participants | 405 Participants | 410 Participants |
| Region of Enrollment Australia | 79 participants | 39 participants | 40 participants |
| Region of Enrollment Europe | 779 participants | 391 participants | 388 participants |
| Sex: Female, Male Female | 457 Participants | 236 Participants | 221 Participants |
| Sex: Female, Male Male | 401 Participants | 194 Participants | 207 Participants |
| Total Nasal Symptom Score (AM + PM) | 9.82 units on a scale (0-3) STANDARD_DEVIATION 4.617 | 9.96 units on a scale (0-3) STANDARD_DEVIATION 4.725 | 9.69 units on a scale (0-3) STANDARD_DEVIATION 4.506 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 163 / — | 146 / — |
| serious Total, serious adverse events | 7 / — | 10 / — |
Outcome results
Primary
Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale.
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.
Time frame: baseline and 12 months/ET
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal bleeding: Total baseline | 428 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Tympanic membranes: Total M12/ET | 414 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal bleeding: baseline-None | 362 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal edema: baseline-None | 32 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal bleeding: baseline-Mild (1+) | 56 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Conjunctiva: baseline-Moderate (2+) | 53 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal bleeding: baseline-Moderate (2+) | 10 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal edema: baseline-Mild (1+) | 91 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal bleeding: baseline-Severe (3+) | 0 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Tympanic membranes: M12/ET-None | 405 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal bleeding: Total M12/ET | 414 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal edema: baseline-Moderate (2+) | 191 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal bleeding: M12/ET-None | 402 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Conjunctiva: M12/ET-Mild (1+) | 44 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal bleeding: M12/ET-Mild (1+) | 11 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal edema: baseline-Severe (3+) | 114 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal bleeding: M12/ET-Moderate (2+) | 1 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Tympanic membranes:M12/ET-Mild (1+) | 8 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal bleeding: M12/ET-Severe (3+) | 0 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal edema: Total M12/ET | 414 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal ulcerations: Total baseline | 428 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Conjunctiva: Total baseline | 428 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal ulcerations: baseline-None | 348 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal edema:M12/ET-None | 160 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal ulcerations: baseline-Mild (1+) | 48 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Tympanic membranes: M12/ET-Moderate (2+) | 1 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal ulcerations: baseline-Moderate (2+) | 26 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal edema: M12/ET-Mild (1+) | 176 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal ulcerations: baseline-Severe (3+) | 6 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Conjunctiva: M12/ET-Moderate (2+) | 4 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal ulcerations: Total M12/ET | 414 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal edema: M12/ET-Moderate (2+) | 69 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal ulcerations: M12/ET-None | 401 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Tympanic membranes:M12/ET Severe (3+) | 0 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal ulcerations: M12/ET-Mild (1+) | 11 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal edema: M12/ET-Severe (3+) | 9 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal ulcerations: M12/ET-Moderate (2+) | 2 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Conjunctiva: baseline-Severe (3+) | 12 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal ulcerations: M12/ET-Severe (3+) | 0 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Nasal discharge: Total baseline | 428 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Crusting of mucosa: Total baseline | 428 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Lymphadenopathy: Total baseline | 428 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Crusting of mucosa: baseline-None | 293 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Nasal discharge: baseline-None | 40 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Crusting of mucosa: baseline-Mild (1+) | 86 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Conjunctiva:M12/ET-Severe (3+) | 0 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Crusting of mucosa: baseline-Moderate (2+) | 36 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Nasal discharge: baseline-Mild (1+) | 113 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Crusting of mucosa: baseline-Severe (3+) | 13 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Lymphadenopathy: baseline-None | 389 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Crusting of mucosa: Total M12/ET | 414 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Nasal discharge: baseline-Moderate (2+) | 179 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Crusting of mucosa: M12/ET-None | 387 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Conjunctiva: baseline-Mild (1+) | 99 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Crusting of mucosa: M12/ET-Mild (1+) | 24 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Nasal discharge: baseline-Severe (3+) | 96 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Crusting of mucosa: M12/ET-Moderate (2+) | 3 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Lymphadenopathy: baseline-Mild (1+) | 32 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Crusting of mucosa:M12/ET-Severe (3+) | 0 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Nasal discharge: Total M12/ET | 414 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Epistaxis: Total baseline | 428 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Tympanic membranes: baseline-None | 342 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Epistaxis: baseline None | 402 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Nasal discharge:M12/ET-None | 178 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Epistaxis: baseline Grade 2 | 26 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Lymphadenopathy: baseline-Moderate (2+) | 7 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Epistaxis: baseline Grade 3 | 0 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Nasal discharge: M12/ET-Mild (1+) | 188 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Epistaxis: baseline Grade 4 | 0 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Tympanic membranes: Total baseline | 428 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Epistaxis:Total M12/ET | 414 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Nasal discharge: M12/ET-Moderate (2+) | 46 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Epistaxis: M12/ET None | 413 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Lymphadenopathy: baseline-Severe (3+) | 0 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Epistaxis: M12/ETGrade 2 | 1 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Nasal discharge:M12/ET-Severe (3+) | 2 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Epistaxis:M12/ET Grade 3 | 0 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Tympanic membranes: baseline-Mild (1+) | 60 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Epistaxis: M12/ETGrade 4 | 0 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal erythema: Total baseline | 428 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Ulceration: Total baseline | 428 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Lymphadenopathy: Total M12/ET | 414 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Ulceration: baseline None | 365 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal erythema: baseline-None | 80 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Ulceration: baseline Grade 2 | 63 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Conjunctiva: Total M12/ET | 414 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Ulceration: baseline Grade 3 | 0 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal erythema: baseline-Mild (1+) | 120 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Ulceration: baseline Grade 4 | 0 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Lymphadenopathy: M12/ET-None | 408 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Ulceration: Total M12/ET | 413 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal erythema: baseline-Monderate (2+) | 171 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Ulceration:M12/ET None | 404 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Tympanic membranes:baselineModerate (2+) | 21 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Ulceration: M12/ET Grade 2 | 8 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal erythema: baseline-Severe (3+) | 57 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Ulceration: M12/ET Grade 3 | 1 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Lymphadenopathy:M12/ET-Mild (1+) | 6 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Ulceration: M12/ET Grade 4 | 0 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal erythema: Total M12/ET | 414 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Pain: Total baseline | 428 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Conjunctiva: baseline-None | 264 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Pain: baseline None | 377 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal erythema: M12/ET-None | 213 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Pain: baseline Grade 2 | 38 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Lymphadenopathy:M12/ET-Moderate (2+) | 0 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Pain: baseline Grade 3 | 6 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal erythema: M12/ET-Mild (1+) | 152 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Pain: baseline Grade 4 | 7 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Tympanic membranes: baseline-Severe (3+) | 5 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Pain: Total M12/ET | 413 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal erythema: M12/ET-Moderate (2+) | 45 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Pain: M12/ET None | 401 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Lymphadenopathy: M12/ET-Severe (3+) | 0 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Pain: M12/ET Grade 2 | 10 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal erythema:M12/ET-Severe (3+) | 4 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Pain: M12/ET Grade 3 | 2 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Conjunctiva: M12/ET-None | 366 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Pain: M12/ET Grade 4 | 0 Participants |
| Astepro Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal edema: Total baseline | 428 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Pain: M12/ET Grade 4 | 0 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Conjunctiva:M12/ET-Severe (3+) | 0 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Conjunctiva: Total baseline | 430 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Conjunctiva: baseline-None | 254 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Conjunctiva: baseline-Mild (1+) | 109 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Conjunctiva: baseline-Moderate (2+) | 54 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Conjunctiva: baseline-Severe (3+) | 13 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Conjunctiva: Total M12/ET | 417 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Conjunctiva: M12/ET-None | 363 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Conjunctiva: M12/ET-Mild (1+) | 43 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Conjunctiva: M12/ET-Moderate (2+) | 11 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Tympanic membranes: Total baseline | 430 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Tympanic membranes: baseline-None | 344 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Tympanic membranes: baseline-Mild (1+) | 62 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Tympanic membranes:baselineModerate (2+) | 17 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Tympanic membranes: baseline-Severe (3+) | 7 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Tympanic membranes: Total M12/ET | 417 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Tympanic membranes: M12/ET-None | 408 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Tympanic membranes:M12/ET-Mild (1+) | 5 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Tympanic membranes: M12/ET-Moderate (2+) | 4 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Tympanic membranes:M12/ET Severe (3+) | 0 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Lymphadenopathy: Total baseline | 430 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Lymphadenopathy: baseline-None | 393 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Lymphadenopathy: baseline-Mild (1+) | 27 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Lymphadenopathy: baseline-Moderate (2+) | 7 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Lymphadenopathy: baseline-Severe (3+) | 3 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Lymphadenopathy: Total M12/ET | 417 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Lymphadenopathy: M12/ET-None | 407 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Lymphadenopathy:M12/ET-Mild (1+) | 10 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Lymphadenopathy:M12/ET-Moderate (2+) | 0 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Lymphadenopathy: M12/ET-Severe (3+) | 0 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal edema: Total baseline | 430 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal edema: baseline-None | 30 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal edema: baseline-Mild (1+) | 80 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal edema: baseline-Moderate (2+) | 200 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal edema: baseline-Severe (3+) | 120 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal edema: Total M12/ET | 417 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal edema:M12/ET-None | 147 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal edema: M12/ET-Mild (1+) | 182 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal edema: M12/ET-Moderate (2+) | 76 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal edema: M12/ET-Severe (3+) | 12 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Nasal discharge: Total baseline | 430 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Nasal discharge: baseline-None | 44 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Nasal discharge: baseline-Mild (1+) | 109 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Nasal discharge: baseline-Moderate (2+) | 183 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Nasal discharge: baseline-Severe (3+) | 94 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Nasal discharge: Total M12/ET | 417 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Nasal discharge:M12/ET-None | 173 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Nasal discharge: M12/ET-Mild (1+) | 183 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Nasal discharge: M12/ET-Moderate (2+) | 54 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Nasal discharge:M12/ET-Severe (3+) | 7 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal erythema: Total baseline | 430 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal erythema: baseline-None | 82 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal erythema: baseline-Mild (1+) | 112 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal erythema: baseline-Monderate (2+) | 178 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal erythema: baseline-Severe (3+) | 58 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal erythema: Total M12/ET | 417 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal erythema: M12/ET-None | 221 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal erythema: M12/ET-Mild (1+) | 153 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal erythema: M12/ET-Moderate (2+) | 35 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal erythema:M12/ET-Severe (3+) | 8 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal bleeding: Total baseline | 430 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal bleeding: baseline-None | 376 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal bleeding: baseline-Mild (1+) | 51 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal bleeding: baseline-Moderate (2+) | 2 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal bleeding: baseline-Severe (3+) | 1 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal bleeding: Total M12/ET | 417 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal bleeding: M12/ET-None | 403 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal bleeding: M12/ET-Mild (1+) | 10 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal bleeding: M12/ET-Moderate (2+) | 4 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal bleeding: M12/ET-Severe (3+) | 0 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal ulcerations: Total baseline | 430 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal ulcerations: baseline-None | 362 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal ulcerations: baseline-Mild (1+) | 37 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal ulcerations: baseline-Moderate (2+) | 25 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal ulcerations: baseline-Severe (3+) | 6 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal ulcerations: Total M12/ET | 417 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal ulcerations: M12/ET-None | 404 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal ulcerations: M12/ET-Mild (1+) | 10 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal ulcerations: M12/ET-Moderate (2+) | 3 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Mucosal ulcerations: M12/ET-Severe (3+) | 0 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Crusting of mucosa: Total baseline | 430 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Crusting of mucosa: baseline-None | 311 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Crusting of mucosa: baseline-Mild (1+) | 75 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Crusting of mucosa: baseline-Moderate (2+) | 35 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Crusting of mucosa: baseline-Severe (3+) | 9 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Crusting of mucosa: Total M12/ET | 417 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Crusting of mucosa: M12/ET-None | 382 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Crusting of mucosa: M12/ET-Mild (1+) | 32 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Crusting of mucosa: M12/ET-Moderate (2+) | 3 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Crusting of mucosa:M12/ET-Severe (3+) | 0 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Epistaxis: Total baseline | 430 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Epistaxis: baseline None | 416 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Epistaxis: baseline Grade 2 | 12 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Epistaxis: baseline Grade 3 | 1 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Epistaxis: baseline Grade 4 | 1 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Epistaxis:Total M12/ET | 417 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Epistaxis: M12/ET None | 415 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Epistaxis: M12/ETGrade 2 | 2 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Epistaxis:M12/ET Grade 3 | 0 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Epistaxis: M12/ETGrade 4 | 0 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Ulceration: Total baseline | 430 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Ulceration: baseline None | 373 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Ulceration: baseline Grade 2 | 57 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Ulceration: baseline Grade 3 | 0 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Ulceration: baseline Grade 4 | 0 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Ulceration: Total M12/ET | 417 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Ulceration:M12/ET None | 411 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Ulceration: M12/ET Grade 2 | 6 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Ulceration: M12/ET Grade 3 | 0 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Ulceration: M12/ET Grade 4 | 0 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Pain: Total baseline | 430 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Pain: baseline None | 382 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Pain: baseline Grade 2 | 28 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Pain: baseline Grade 3 | 17 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Pain: baseline Grade 4 | 3 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Pain: Total M12/ET | 417 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Pain: M12/ET None | 409 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Pain: M12/ET Grade 2 | 6 Participants |
| Astelin Nasal Spray | Focused Examination of the Head and Neck With Findings Recorded on a Numeric Scale. | Pain: M12/ET Grade 3 | 2 Participants |
Primary
Number of Participants Reporting Adverse Events
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.
Time frame: 12 months
Population: Number of participants for analysis was based on a safety population that included any subject who received at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Astepro Nasal Spray | Number of Participants Reporting Adverse Events | 207 Participants |
| Astelin Nasal Spray | Number of Participants Reporting Adverse Events | 211 Participants |
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.
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.
Time frame: baseline, months 1,3,6,9 and 12/or early termination
Population: Analysis is based on safety population, which is defined as subjects who took at least one dose of study medication.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Astepro Nasal Spray | 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 | 2.25 Units on a scale | Standard Deviation 1.103 |
| Astepro Nasal Spray | Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination. | Month 1 | -0.77 Units on a scale | Standard Deviation 1.007 |
| Astepro Nasal Spray | Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination. | Month 3 | -1.00 Units on a scale | Standard Deviation 1.063 |
| Astepro Nasal Spray | Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination. | Month 6 | -1.04 Units on a scale | Standard Deviation 1.206 |
| Astepro Nasal Spray | Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination. | Month 9 | -1.09 Units on a scale | Standard Deviation 1.228 |
| Astepro Nasal Spray | Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination. | Month 12/Early termination | -0.88 Units on a scale | Standard Deviation 1.385 |
| Astelin Nasal Spray | Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination. | Month 9 | -1.16 Units on a scale | Standard Deviation 1.197 |
| Astelin Nasal Spray | 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 | 2.18 Units on a scale | Standard Deviation 1.05 |
| Astelin Nasal Spray | Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination. | Month 6 | -0.94 Units on a scale | Standard Deviation 1.23 |
| Astelin Nasal Spray | Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination. | Month 1 | -0.83 Units on a scale | Standard Deviation 0.959 |
| Astelin Nasal Spray | Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination. | Month 12/Early termination | -0.90 Units on a scale | Standard Deviation 1.339 |
| Astelin Nasal Spray | Adult Mini-Rhinoconjuctivitis Quality of Life Questionnaire. Change From Baseline in RQLQ Score at Months 1,3,6,9 and 12/or Early Termination. | Month 3 | -1.00 Units on a scale | Standard Deviation 1.048 |
Comparison: Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.p-value: 0.368ANOVA
Comparison: Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.p-value: 0.327ANCOVA
Comparison: Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.p-value: 0.991ANCOVA
Comparison: Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.p-value: 0.168ANCOVA
Comparison: Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.p-value: 0.319ANCOVA
Comparison: Sample size was based on ICH Guideline E1:The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions. Comparisons performed using ANCOVA with baseline as a covariate. The model included treatment group and country as fixed effects to estimate least squares means.p-value: 0.725ANCOVA