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The purpose of this study was to assess local nasal adverse effects, as well as systemic effects, of PATANASE nasal spray when compared with Patanase Vehicle, pH 3.7 and Patanase Vehicle, pH 7.0 in patients with perennial allergic rhinitis (PAR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PATANASE | Experimental | Olopatadine hydrochloride 0.6% nasal spray (PATANASE), two sprays in each nostril twice a day (morning and evening) for up to 12 months |
|
| Patanase Vehicle, pH 3.7 | Placebo Comparator | Olopatadine nasal spray vehicle, pH 3.7, two sprays in each nostril twice a day (morning and evening) for up to 12 months |
|
| Patanase Vehicle, pH 7.0 | Placebo Comparator | Olopatadine nasal spray vehicle, pH 7.0, two sprays in each nostril twice a day (morning and evening) for up to 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olopatadine hydrochloride 0.6% nasal spray (PATANASE) | Drug | Two sprays in each nostril twice a day (morning and evening) for up to 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner) | Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article. | Baseline (Day 0), Exit (Month 12 or sooner) |
| Self-Rated Relief Assessment at Day 30 | Relief assessment as rated by the subject on a 4-point scale, where 1=complete relief and 4=no relief. The subject answered the following question: "I would rate the study medication's effectiveness for relieving my allergy symptoms since my last visit as: (1) Complete Relief; (2) Moderate Relief; (3) Mild Relief; (4) No Relief." | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Percentage of subjects with change from baseline in pulse measurement to time of exit, as recorded based on a full 60-second count after the patient rested for five minutes. | Baseline (Day 0), Exit (Month 12 or sooner) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center For Trial Locations | Fort Worth | Texas | 76134 | United States |
234 subjects were enrolled under protocol Version 1.0, then exited due to a revision in the study plan. A new cohort of 1026 subjects was enrolled in protocol Version 2.0, for a total enrollment of 1260 subjects.
Subjects were recruited and enrolled from 69 US study centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | PATANASE | Two sprays in each nostril twice a day for up to 12 months |
| FG001 | Patanase Vehicle, pH 3.7 | Two sprays in each nostril twice a day for up to 12 months |
| FG002 | Patanase Vehicle, pH 7.0 | Two sprays in each nostril twice a day for up to 12 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PATANASE | Two sprays in each nostril twice a day for up to 12 months |
| BG001 | Patanase Vehicle, pH 3.7 | Two sprays in each nostril twice a day for up to 12 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner) | Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article. | This analysis population includes all subjects who received study drug (Safety Analysis Set), minus any missing data. | Posted | Number | Percentage of subjects | Baseline (Day 0), Exit (Month 12 or sooner) |
|
Adverse events were collected for the duration of the study: 2 years, 1 month, 16 days. Adverse events were defined as any untoward (unfavorable and unintended) medical occurrence in a subject administered a test article.
Adverse events were collected after the first dose of study medication at Visit 1 and during each monthly on-therapy study visit through Visit 13 (or Early Exit). Safety Analysis Set was used for analysis.
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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 | PATANASE | Two sprays in each nostril twice a day for up to 12 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adenocarcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment | Not related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Terri Pasquine, Sr. Clinical Lead | Alcon Research | 817-551-4760 | terri.pasquine@alconlabs.com |
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| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract 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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| Olopatadine nasal spray vehicle, pH 3.7 | Other | Two sprays in each nostril twice a day (morning and evening) for up to 12 months |
|
| Olopatadine nasal spray vehicle, pH 7.0 | Other | Two sprays in each nostril twice a day (morning and evening) for up to 12 months |
|
| Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) |
Percentage of subjects with change from baseline in systolic blood pressure to time of exit, as obtained in a sitting position after the subject rested for five minutes. Two measurements, separated by two minutes, were obtained, from which the average systolic pressure was derived. If the first two readings differed by more than 5 millimeters of mercury (mmHg), a third reading was taken two minutes later and all three were used to determine the average. The first appearance of sound (phase 1) was used to define systolic blood pressure. |
| Baseline (Day 0), Exit (Month 12 or sooner) |
| Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Percentage of subjects with change from baseline in diastolic blood pressure to time of exit, as obtained in a sitting position after the subject rested for five minutes. Two measurements, separated by two minutes, were obtained, from which the average systolic pressure was derived. If the first two readings differed by more than 5 millimeters of mercury (mmHg), a third reading was taken two minutes later and all three were used to determine the average. The disappearance of sound (phase 5) was used to define diastolic blood pressure. | Baseline (Day 0), Exit (Month 12 or sooner) |
| Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article. | Baseline (Day 0), Exit (Month 12 or sooner) |
| Lost to Follow-up |
|
| Patient decision unnrelated to adv event |
|
| Treatment failure |
|
| Protocol Violation |
|
| BG002 | Patanase Vehicle, pH 7.0 | Two sprays in each nostril twice a day for up to 12 months |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Two sprays in each nostril twice a day for up to 12 months |
| OG002 | Patanase Vehicle, pH 7.0 | Two sprays in each nostril twice a day for up to 12 months |
|
|
| Secondary | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Percentage of subjects with change from baseline in pulse measurement to time of exit, as recorded based on a full 60-second count after the patient rested for five minutes. | Safety Analysis Set, minus any missing data. | Posted | Number | Percentage of subjects | Baseline (Day 0), Exit (Month 12 or sooner) |
|
|
|
| Secondary | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Percentage of subjects with change from baseline in systolic blood pressure to time of exit, as obtained in a sitting position after the subject rested for five minutes. Two measurements, separated by two minutes, were obtained, from which the average systolic pressure was derived. If the first two readings differed by more than 5 millimeters of mercury (mmHg), a third reading was taken two minutes later and all three were used to determine the average. The first appearance of sound (phase 1) was used to define systolic blood pressure. | Safety Analysis Set, minus any missing data. | Posted | Number | Percentage of subjects | Baseline (Day 0), Exit (Month 12 or sooner) |
|
|
|
| Secondary | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Percentage of subjects with change from baseline in diastolic blood pressure to time of exit, as obtained in a sitting position after the subject rested for five minutes. Two measurements, separated by two minutes, were obtained, from which the average systolic pressure was derived. If the first two readings differed by more than 5 millimeters of mercury (mmHg), a third reading was taken two minutes later and all three were used to determine the average. The disappearance of sound (phase 5) was used to define diastolic blood pressure. | Safety Analysis Set, minus any missing data. | Posted | Number | Percentage of subjects | Baseline (Day 0), Exit (Month 12 or sooner) |
|
|
|
| Secondary | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Percentage of subjects with clinically relevant change from baseline in protocol-specific safety parameters to time of exit, based on the assessment of the investigator, regardless of causality (related or not related) to test article. | Safety Analysis Set, minus any missing data. | Posted | Number | Percentage of subjects | Baseline (Day 0), Exit (Month 12 or sooner) |
|
|
|
| Primary | Self-Rated Relief Assessment at Day 30 | Relief assessment as rated by the subject on a 4-point scale, where 1=complete relief and 4=no relief. The subject answered the following question: "I would rate the study medication's effectiveness for relieving my allergy symptoms since my last visit as: (1) Complete Relief; (2) Moderate Relief; (3) Mild Relief; (4) No Relief." | Analysis population included all subjects enrolled under protocol Version 2.0 who received study drug and attended at least one on-therapy study visit (ITT). The LOCF (last observation carried forward method) was used to impute missing data. | Posted | Mean | Standard Deviation | Units on a scale | Day 30 |
|
|
|
| 8 |
| 421 |
| 220 |
| 421 |
| EG001 | Patanase Vehicle, pH 3.7 | Two sprays in each nostril twice a day for up to 12 months | 7 | 417 | 213 | 417 |
| EG002 | Patanase Vehicle, pH 7.0 | Two sprays in each nostril twice a day for up to 12 months | 14 | 422 | 214 | 422 |
|
| Anxiety | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Appendicitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Atrial flutter | Cardiac disorders | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Atrioventricular block complete | Cardiac disorders | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Cellulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Chest Pain | General disorders | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Cystostomy closure | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Endometriosis | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Herpes zoster oticus | Infections and infestations | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Internal fixation of fracture | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Intravertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Jaw disorder | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Menometrorrhagia | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Periorbital cellulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment | Related |
|
| Sialoadenitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Spinal fusion surgery | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment | Not related |
|
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Nasal ulcer | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
Alcon reserves the right of prior review of any publication or presentation of information related to the study.
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000336 | Aerosols |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
|
| Decrease 11-20 BPM |
|
| Decrease 1-10 BPM |
|
| No Change |
|
| Increase 1-10 BPM |
|
| Increase 11-20 BPM |
|
| Increase 21-30 BPM |
|
| Increase greater than 30 BPM |
|
|
| Decrease 11-20 mmHg |
|
| Decrease 1-10 mmHg |
|
| No change |
|
| Increase 1-10 mmHg |
|
| Increase 11-20 mmHg |
|
| Increase 21-30 mmHg |
|
| Increase greater than 30 mmHg |
|
|
| Decrease 11-20 mmHg |
|
| Decrease 1-10 mmHg |
|
| No change |
|
| Increase 1-10 mmHg |
|
| Increase 11-20 mmHg |
|
| Increase 21-30 mmHg |
|
| Increase greater than 30 mmHg |
|
| Title | Measurements |
|---|---|
|
| Cardiovascular |
|
| Pulmonary |
|
| Abdomen |
|
| Skin and Extremities |
|
| Neurological |
|
| Lymph Nodes |
|
| Musculoskeletal |
|