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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Astepro Nasal Spray (0.1% azelastine hydrochloride) |
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| 2 | Active Comparator | Astelin Nasal Spray (0.1% azelastine hydrochloride) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Astepro Nasal Spray (0.1% azelastine hydrochloride) | Drug | 548 mcg (2 sprays per nostril) twice a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| 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. | baseline and 12 months/ET |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lewis M. Fredane, MD | Meda Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meda Clinical Trials Contact Center | Somerset | New Jersey | 08873 | United States |
Subjects participated in a one-week screening period to identify appropriate subjects based on symptom scores
First observation 24 July 2006 and last observation 28 Dec 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Astepro Nasal Spray | (0.1% azelastine hydrochloride) |
| FG001 | Astelin Nasal Spray | (0.1% azelastine hydrochloride) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Astelin Nasal Spray (0.1% azelastine hydrochloride) |
| Drug |
548 mcg (2 sprays per nostril) twice a day |
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| baseline, months 1,3,6,9 and 12/or early termination |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Astepro Nasal Spray | (0.1% azelastine hydrochloride) |
| BG001 | Astelin Nasal Spray | (0.1% azelastine hydrochloride) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Duration of Rhinitis | Mean | Standard Deviation | years |
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| Total Nasal Symptom Score (AM + PM) | TNSS scale: 0=no symptoms, 1=mild symptoms, 2=moderate symptoms and 3 = severe symptoms scored twice daily such that the maximum daily score is 24. | Mean | Standard Deviation | units on a scale (0-3) |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Number of participants for analysis was based on a safety population that included any subject who received at least one dose of study medication. | Posted | Nov 2008 | Number | Participants | 12 months |
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| 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. | Posted | Nov 2008 | Number | Participants | baseline and 12 months/ET |
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| 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. | Analysis is based on safety population, which is defined as subjects who took at least one dose of study medication. | Posted | Least Squares Mean | Standard Deviation | Units on a scale | baseline, months 1,3,6,9 and 12/or early termination |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Astepro Nasal Spray | (0.1% azelastine hydrochloride) | 7 | 163 | ||||
| EG001 | Astelin Nasal Spray | (0.1% azelastine hydrochloride) | 10 | 146 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Battery change for internal cardiac defibrillator | Cardiac disorders | MedDRA | Systematic Assessment |
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| Sialoadenitis | Infections and infestations | MedDRA | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Acute Pyelonephritis | Infections and infestations | MedDRA | Systematic Assessment |
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| Knee traumatism | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Rectal Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Exacerbation angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
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| Central Chest Pain | Cardiac disorders | MedDRA | Systematic Assessment |
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| Exacerbation right shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Removal of bladder stones | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Ovarian Cyst | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Exertional dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
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| Pneumonia Chlamidalis | Infections and infestations | MedDRA | Systematic Assessment |
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| Spontaneous Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA | Systematic Assessment |
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| Fracture left foot | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Broken nose | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
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| Upper Abdominal Colic | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Total right hip replacement | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
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| Pharyngolaryngeal Pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Wheeler, PhD | Meda Pharmaceuticals | 732-564-2351 | wwheeler@medapharma.us |
| ID | Term |
|---|---|
| C020976 | azelastine |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Europe |
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