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The purpose of this study is to determine whether olopatadine nasal spray is safe and effective when used for up to one year by patients with perennial allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olopatadine 0.6% Nasal Spray | Experimental | 2 sprays each nostril twice daily |
|
| Placebo Nasal Spray | Placebo Comparator | 2 sprays each nostril twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olopatadine 0.6% nasal spray | Drug | 2 sprays each nostril twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire | Mean Patient-Rated Relief Assessment at Day 30. The patient-rated relief assessment (PRRA) was a 4-point scale with 1=Complete Relief; 2=Moderate Relief; 3=Mild Relief; and 4=No Relief. | day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Number of Days of Rescue Medication Taken | Month 1 through Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Drake | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Waco | Waco | Texas | 76712 | United States |
Patients were randomized at Visit 1 upon meeting inclusion/exclusion.
Patients were recruited between December 2006 and January 2007 at medical offices in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Nasal Spray | 2 sprays each nostril twice daily |
| FG001 | Olopatadine 0.6% Nasal Spray | 2 sprays each nostril twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Nasal Spray | |
| BG001 | Olopatadine 0.6% Nasal Spray | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Mean Response at Day 30 to the Patient-rated Relief Assessment Questionnaire | Mean Patient-Rated Relief Assessment at Day 30. The patient-rated relief assessment (PRRA) was a 4-point scale with 1=Complete Relief; 2=Moderate Relief; 3=Mild Relief; and 4=No Relief. | 29 patients had missing mean patient-rated relief assessment data. | Posted | Jul 2009 | Mean | Standard Deviation | Unit on PRRA scale | day 30 |
|
|
1 year
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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 | Placebo Nasal Spray |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Research, Ltd. | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
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| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| D012220 | Rhinitis |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D000069605 | Olopatadine Hydrochloride |
| D059085 | Nasal Sprays |
| ID | Term |
|---|---|
| D003990 | Dibenzoxepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo Nasal Spray |
| Drug |
2 sprays each nostril twice daily |
|
Total of all reporting groups
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Average Number of Days of Rescue Medication Taken | 12 patients had missing average use of rescue medication data. | Posted | Jul 2009 | Mean | Standard Deviation | Days | Month 1 through Month 12 |
|
|
|
| 15 |
| 445 |
| 319 |
| 445 |
| EG001 | Olopatadine 0.6% Nasal Spray | 15 | 445 | 309 | 445 |
| Appendicitis | Infections and infestations | MedDRA Version 11.0 | Systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA Version 11.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Faecaloma | Gastrointestinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Genital prolapse | Reproductive system and breast disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Hip dysplasia | Congenital, familial and genetic disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Hyperemesis gravidarum | Pregnancy, puerperium and perinatal conditions | MedDRA Version 11.0 | Systematic Assessment |
|
| Hysterectomy | Surgical and medical procedures | MedDRA Version 11.0 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Systematic Assessment |
|
| Intervertebral disc operation | Surgical and medical procedures | MedDRA Version 11.0 | Systematic Assessment |
|
| Joint surgery | Surgical and medical procedures | MedDRA Version 11.0 | Systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA Version 11.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Systematic Assessment |
|
| Peripheral embolism | Vascular disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Systematic Assessment |
|
| Thyroidectomy | Surgical and medical procedures | MedDRA Version 11.0 | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 11.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA Version 11.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 11.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA Version 11.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA Version 11.0 | Systematic Assessment |
|
| Nasal ulcer | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA Version 11.0 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 11.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 11.0 | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA Version 11.0 | Systematic Assessment |
|
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| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D000336 | Aerosols |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |