Perennial Allergic Rhinitis
Conditions
Keywords
nasal allergy, nasal spray, seasonal allergy, perennial allergy
Brief summary
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).
Interventions
DRUGOlopatadine hydrochloride 0.6% nasal spray (PATANASE)
Two sprays in each nostril twice a day (morning and evening) for up to 12 months
OTHEROlopatadine nasal spray vehicle, pH 3.7
Two sprays in each nostril twice a day (morning and evening) for up to 12 months
OTHEROlopatadine nasal spray vehicle, pH 7.0
Two sprays in each nostril twice a day (morning and evening) for up to 12 months
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Sign informed consent; 2. Normal nasal exam; 3. History of perennial allergic rhinitis; 4. Allergy to perennial allergen documented by allergy testing; 5. Age 12 years and older; 6. Must follow instructions; 7. Must make required study visits; 8. Negative pregnancy test and adequate birth control methods for females of childbearing potential; 9. Refrain from certain allergy medications during the study; 10. Other protocol-defined inclusion criteria may apply.
Exclusion criteria
1. Nasal disorders; 2. Use of substances that affect the nasal septum; 3. Exposure to industrial metal plating solutions; 4. Uncontrolled, severe, or unstable diseases; 5. Hypersensitivity to the study drug or nasal spray components; 6. Relative of site staff with access to the protocol; 7. Participation in another investigational study within 30 days or at the same time as this study; 8. Medical Monitor decision; 9. Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner) | Baseline (Day 0), 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. |
| Self-Rated Relief Assessment at Day 30 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Baseline (Day 0), 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. |
| Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Baseline (Day 0), 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. |
| Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Baseline (Day 0), 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. |
| Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Baseline (Day 0), 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited and enrolled from 69 US study centers.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| PATANASE Two sprays in each nostril twice a day for up to 12 months | 421 |
| Patanase Vehicle, pH 3.7 Two sprays in each nostril twice a day for up to 12 months | 417 |
| Patanase Vehicle, pH 7.0 Two sprays in each nostril twice a day for up to 12 months | 422 |
| Total | 1,260 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 17 | 7 | 10 |
| Overall Study | Lost to Follow-up | 9 | 10 | 18 |
| Overall Study | Patient decision unnrelated to adv event | 38 | 29 | 26 |
| Overall Study | Protocol Amendment | 78 | 76 | 80 |
| Overall Study | Protocol Violation | 6 | 9 | 13 |
| Overall Study | Treatment failure | 11 | 8 | 12 |
Baseline characteristics
| Characteristic | PATANASE | Patanase Vehicle, pH 3.7 | Patanase Vehicle, pH 7.0 | Total |
|---|---|---|---|---|
| Age, Continuous | 36.8 years STANDARD_DEVIATION 14.5 | 36.2 years STANDARD_DEVIATION 14.2 | 38.3 years STANDARD_DEVIATION 14.6 | 37.1 years STANDARD_DEVIATION 14.4 |
| Region of Enrollment United States | 421 participants | 417 participants | 422 participants | 1260 participants |
| Sex: Female, Male Female | 251 Participants | 260 Participants | 278 Participants | 789 Participants |
| Sex: Female, Male Male | 170 Participants | 157 Participants | 144 Participants | 471 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 220 / 421 | 213 / 417 | 214 / 422 |
| serious Total, serious adverse events | 8 / 421 | 7 / 417 | 14 / 422 |
Outcome results
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.
Time frame: Baseline (Day 0), Exit (Month 12 or sooner)
Population: This analysis population includes all subjects who received study drug (Safety Analysis Set), minus any missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PATANASE | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner) | Bleeding | 0.8 Percentage of subjects |
| PATANASE | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner) | Possible Ulcerations | 0.5 Percentage of subjects |
| PATANASE | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner) | Anatomic Abnormalities | 0.8 Percentage of subjects |
| PATANASE | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner) | Infection | 0.3 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner) | Anatomic Abnormalities | 1.3 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner) | Bleeding | 1.0 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner) | Infection | 1.0 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner) | Possible Ulcerations | 0.5 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner) | Infection | 0.0 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner) | Bleeding | 2.6 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner) | Anatomic Abnormalities | 0.3 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Nasal Examination Parameters to Exit (Month 12 or Sooner) | Possible Ulcerations | 1.6 Percentage of subjects |
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.
Time frame: Day 30
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PATANASE | Self-Rated Relief Assessment at Day 30 | 2.4 Units on a scale | Standard Deviation 0.9 |
| Patanase Vehicle, pH 3.7 | Self-Rated Relief Assessment at Day 30 | 2.7 Units on a scale | Standard Deviation 1 |
| Patanase Vehicle, pH 7.0 | Self-Rated Relief Assessment at Day 30 | 2.7 Units on a scale | Standard Deviation 0.9 |
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.
Time frame: Baseline (Day 0), Exit (Month 12 or sooner)
Population: Safety Analysis Set, minus any missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Decrease greater than 30 mmHg | 0.0 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Increase greater than 30 mmHg | 0.0 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Decrease 1-10 mmHg | 44.5 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | No change | 7.5 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Increase 11-20 mmHg | 5.3 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Increase 1-10 mmHg | 33.2 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Decrease 21-30 mmHg | 0.7 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Increase 21-30 mmHg | 0.2 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Decrease 11-20 mmHg | 8.7 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Increase 11-20 mmHg | 6.5 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Increase 21-30 mmHg | 0.5 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Increase greater than 30 mmHg | 0.0 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Decrease greater than 30 mmHg | 0.2 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Decrease 21-30 mmHg | 1.0 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Decrease 11-20 mmHg | 13.6 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Decrease 1-10 mmHg | 38.7 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | No change | 6.1 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Increase 1-10 mmHg | 33.4 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Decrease 21-30 mmHg | 0.5 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Decrease 11-20 mmHg | 11.5 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Increase 1-10 mmHg | 33.7 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Increase greater than 30 mmHg | 0.0 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Increase 21-30 mmHg | 0.0 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Decrease 1-10 mmHg | 42.6 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Decrease greater than 30 mmHg | 0.2 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | Increase 11-20 mmHg | 5.0 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Diastolic) to Exit (Month 12 or Sooner) | No change | 6.5 Percentage of subjects |
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.
Time frame: Baseline (Day 0), Exit (Month 12 or sooner)
Population: Safety Analysis Set, minus any missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Increase greater than 30 mmHg | 0.0 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Increase 21-30 mmHg | 1.2 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | No change | 4.6 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Decrease 21-30 mmHg | 1.0 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Decrease greater than 30 mmHg | 0.5 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Decrease 1-10 mmHg | 35.3 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Increase 11-20 mmHg | 10.6 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Decrease 11-20 mmHg | 11.8 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Increase 1-10 mmHg | 35.1 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Decrease 21-30 mmHg | 2.4 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Decrease 11-20 mmHg | 9.2 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Decrease 1-10 mmHg | 36.3 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Increase 21-30 mmHg | 1.9 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Increase greater than 30 mmHg | 0.0 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Decrease greater than 30 mmHg | 1.2 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | No change | 5.3 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Increase 1-10 mmHg | 33.4 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Increase 11-20 mmHg | 10.2 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | No change | 5.3 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Increase 21-30 mmHg | 1.2 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Decrease 1-10 mmHg | 35.4 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Increase 1-10 mmHg | 34.4 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Increase greater than 30 mmHg | 0.2 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Increase 11-20 mmHg | 10.5 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Decrease 11-20 mmHg | 10.0 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Decrease 21-30 mmHg | 2.4 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Blood Pressure (Systolic) to Exit (Month 12 or Sooner) | Decrease greater than 30 mmHg | 0.5 Percentage of subjects |
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.
Time frame: Baseline (Day 0), Exit (Month 12 or sooner)
Population: Safety Analysis Set, minus any missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Increase 21-30 BPM | 1.4 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | No Change | 7.5 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Decrease 21-30 BPM | 0.7 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Increase 11-20 BPM | 16.8 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Decrease greater than 30 BPM | 0.0 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Decrease 11-20 BPM | 7.5 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Increase greater than 30 BPM | 0.2 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Increase 1-10 BPM | 38.7 Percentage of subjects |
| PATANASE | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Decrease 1-10 BPM | 27.2 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Increase 1-10 BPM | 38.9 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Increase 11-20 BPM | 9.9 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Increase 21-30 BPM | 3.6 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Increase greater than 30 BPM | 0.2 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Decrease greater than 30 BPM | 0.0 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Decrease 21-30 BPM | 1.2 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | No Change | 6.5 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Decrease 11-20 BPM | 9.2 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Decrease 1-10 BPM | 30.4 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Decrease 21-30 BPM | 0.5 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Decrease 1-10 BPM | 34.7 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | No Change | 7.9 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Increase greater than 30 BPM | 0.7 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Decrease greater than 30 BPM | 0.0 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Decrease 11-20 BPM | 6.2 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Increase 1-10 BPM | 39.7 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Increase 11-20 BPM | 8.9 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Change From Baseline (Day 0) in Pulse Rate Beats Per Minute (BPM) to Exit (Month 12 or Sooner) | Increase 21-30 BPM | 1.4 Percentage of subjects |
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.
Time frame: Baseline (Day 0), Exit (Month 12 or sooner)
Population: Safety Analysis Set, minus any missing data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PATANASE | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Skin and Extremities | 1.2 Percentage of subjects |
| PATANASE | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Neck | 0.0 Percentage of subjects |
| PATANASE | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Lymph Nodes | 0.0 Percentage of subjects |
| PATANASE | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Musculoskeletal | 0.0 Percentage of subjects |
| PATANASE | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Neurological | 0.7 Percentage of subjects |
| PATANASE | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Head/EENT | 5.2 Percentage of subjects |
| PATANASE | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Cardiovascular | 0.0 Percentage of subjects |
| PATANASE | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Pulmonary | 0.7 Percentage of subjects |
| PATANASE | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Abdomen | 0.0 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Pulmonary | 0.2 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Abdomen | 0.0 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Skin and Extremities | 0.5 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Neurological | 0.0 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Lymph Nodes | 0.2 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Neck | 0.7 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Cardiovascular | 0.5 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Musculoskeletal | 0.5 Percentage of subjects |
| Patanase Vehicle, pH 3.7 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Head/EENT | 4.2 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Musculoskeletal | 0.5 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Head/EENT | 4.6 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Skin and Extremities | 1.3 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Lymph Nodes | 0.0 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Neck | 0.0 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Cardiovascular | 0.3 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Pulmonary | 0.3 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Abdomen | 0.3 Percentage of subjects |
| Patanase Vehicle, pH 7.0 | Percentage of Subjects With Clinically Relevant Change From Baseline (Day 0) in Physical Examination Parameters to Exit (Month 12 or Sooner) | Neurological | 0.0 Percentage of subjects |