Trial Outcomes & Findings for Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis (NCT NCT00789555)

Last Updated: 2018-02-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1260 participants

Primary outcome timeframe

Baseline (Day 0), Exit (Month 12 or sooner)

Results posted on

2018-02-08

Participant Flow

Subjects were recruited and enrolled from 69 US study centers.

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.

Participant milestones

Participant milestones
Measure	PATANASE Two sprays in each nostril twice a day for up to 12 months	Patanase Vehicle, pH 3.7 Two sprays in each nostril twice a day for up to 12 months	Patanase Vehicle, pH 7.0 Two sprays in each nostril twice a day for up to 12 months
Overall Study STARTED	421	417	422
Overall Study COMPLETED	262	278	263
Overall Study NOT COMPLETED	159	139	159

Reasons for withdrawal

Reasons for withdrawal
Measure	PATANASE Two sprays in each nostril twice a day for up to 12 months	Patanase Vehicle, pH 3.7 Two sprays in each nostril twice a day for up to 12 months	Patanase Vehicle, pH 7.0 Two sprays in each nostril twice a day for up to 12 months
Overall Study Protocol Amendment	78	76	80
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 Treatment failure	11	8	12
Overall Study Protocol Violation	6	9	13

Baseline Characteristics

Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PATANASE n=421 Participants Two sprays in each nostril twice a day for up to 12 months	Patanase Vehicle, pH 3.7 n=417 Participants Two sprays in each nostril twice a day for up to 12 months	Patanase Vehicle, pH 7.0 n=422 Participants Two sprays in each nostril twice a day for up to 12 months	Total n=1260 Participants Total of all reporting groups
Age, Continuous	36.8 years STANDARD_DEVIATION 14.5 • n=5 Participants	36.2 years STANDARD_DEVIATION 14.2 • n=7 Participants	38.3 years STANDARD_DEVIATION 14.6 • n=5 Participants	37.1 years STANDARD_DEVIATION 14.4 • n=4 Participants
Sex: Female, Male Female	251 Participants n=5 Participants	260 Participants n=7 Participants	278 Participants n=5 Participants	789 Participants n=4 Participants
Sex: Female, Male Male	170 Participants n=5 Participants	157 Participants n=7 Participants	144 Participants n=5 Participants	471 Participants n=4 Participants
Region of Enrollment United States	421 participants n=5 Participants	417 participants n=7 Participants	422 participants n=5 Participants	1260 participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	PATANASE n=386 Participants Two sprays in each nostril twice a day for up to 12 months	Patanase Vehicle, pH 3.7 n=386 Participants Two sprays in each nostril twice a day for up to 12 months	Patanase Vehicle, pH 7.0 n=381 Participants Two sprays in each nostril twice a day for up to 12 months
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	1.3 Percentage of subjects	0.3 Percentage of subjects
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	1.0 Percentage of subjects	2.6 Percentage of subjects
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	1.0 Percentage of subjects	0.0 Percentage of subjects
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	0.5 Percentage of subjects	1.6 Percentage of subjects

PRIMARY outcome

Timeframe: 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.

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."

Outcome measures

Outcome measures
Measure	PATANASE n=328 Participants Two sprays in each nostril twice a day for up to 12 months	Patanase Vehicle, pH 3.7 n=331 Participants Two sprays in each nostril twice a day for up to 12 months	Patanase Vehicle, pH 7.0 n=330 Participants Two sprays in each nostril twice a day for up to 12 months
Self-Rated Relief Assessment at Day 30	2.4 Units on a scale Standard Deviation 0.9	2.7 Units on a scale Standard Deviation 1.0	2.7 Units on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: Baseline (Day 0), Exit (Month 12 or sooner)

Population: Safety Analysis Set, minus any missing data.

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.

Outcome measures

Outcome measures
Measure	PATANASE n=416 Participants Two sprays in each nostril twice a day for up to 12 months	Patanase Vehicle, pH 3.7 n=414 Participants Two sprays in each nostril twice a day for up to 12 months	Patanase Vehicle, pH 7.0 n=418 Participants Two sprays in each nostril twice a day for up to 12 months
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	0.0 Percentage of subjects	0.0 Percentage of subjects
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	1.2 Percentage of subjects	0.5 Percentage of subjects
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	9.9 Percentage of subjects	8.9 Percentage of subjects
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	9.2 Percentage of subjects	6.2 Percentage of subjects
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	30.4 Percentage of subjects	34.7 Percentage of subjects
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	6.5 Percentage of subjects	7.9 Percentage of subjects
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	38.9 Percentage of subjects	39.7 Percentage of subjects
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	3.6 Percentage of subjects	1.4 Percentage of subjects
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	0.2 Percentage of subjects	0.7 Percentage of subjects

SECONDARY outcome

Timeframe: Baseline (Day 0), Exit (Month 12 or sooner)

Population: Safety Analysis Set, minus any missing data.

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.

Outcome measures

Outcome measures
Measure	PATANASE n=416 Participants Two sprays in each nostril twice a day for up to 12 months	Patanase Vehicle, pH 3.7 n=413 Participants Two sprays in each nostril twice a day for up to 12 months	Patanase Vehicle, pH 7.0 n=418 Participants Two sprays in each nostril twice a day for up to 12 months
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	1.2 Percentage of subjects	0.5 Percentage of subjects
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	2.4 Percentage of subjects	2.4 Percentage of subjects
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	9.2 Percentage of subjects	10.0 Percentage of subjects
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	36.3 Percentage of subjects	35.4 Percentage of subjects
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	5.3 Percentage of subjects	5.3 Percentage of subjects
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	10.2 Percentage of subjects	10.5 Percentage of subjects
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	0.0 Percentage of subjects	0.2 Percentage of subjects
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	33.4 Percentage of subjects	34.4 Percentage of subjects
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	1.9 Percentage of subjects	1.2 Percentage of subjects

SECONDARY outcome

Timeframe: Baseline (Day 0), Exit (Month 12 or sooner)

Population: Safety Analysis Set, minus any missing data.

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.

Outcome measures

Outcome measures
Measure	PATANASE n=416 Participants Two sprays in each nostril twice a day for up to 12 months	Patanase Vehicle, pH 3.7 n=413 Participants Two sprays in each nostril twice a day for up to 12 months	Patanase Vehicle, pH 7.0 n=418 Participants Two sprays in each nostril twice a day for up to 12 months
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	0.0 Percentage of subjects	0.0 Percentage of subjects
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	0.2 Percentage of subjects	0.2 Percentage of subjects
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	1.0 Percentage of subjects	0.5 Percentage of subjects
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	13.6 Percentage of subjects	11.5 Percentage of subjects
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	38.7 Percentage of subjects	42.6 Percentage of subjects
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	6.1 Percentage of subjects	6.5 Percentage of subjects
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	33.4 Percentage of subjects	33.7 Percentage of subjects
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	6.5 Percentage of subjects	5.0 Percentage of subjects
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	0.5 Percentage of subjects	0.0 Percentage of subjects

SECONDARY outcome

Timeframe: Baseline (Day 0), Exit (Month 12 or sooner)

Population: Safety Analysis Set, minus any missing data.

Outcome measures

Outcome measures
Measure	PATANASE n=404 Participants Two sprays in each nostril twice a day for up to 12 months	Patanase Vehicle, pH 3.7 n=403 Participants Two sprays in each nostril twice a day for up to 12 months	Patanase Vehicle, pH 7.0 n=392 Participants Two sprays in each nostril twice a day for up to 12 months
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	0.5 Percentage of subjects	0.3 Percentage of subjects
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	0.0 Percentage of subjects	0.3 Percentage of subjects
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	0.5 Percentage of subjects	1.3 Percentage of subjects
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	0.0 Percentage of subjects	0.0 Percentage of subjects
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	4.2 Percentage of subjects	4.6 Percentage of subjects
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	0.7 Percentage of subjects	0.0 Percentage of subjects
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	0.2 Percentage of subjects	0.3 Percentage of subjects
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	0.2 Percentage of subjects	0.0 Percentage of subjects
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	0.5 Percentage of subjects	0.5 Percentage of subjects

Adverse Events

PATANASE

Serious events: 8 serious events

Other events: 220 other events

Deaths: 0 deaths

Patanase Vehicle, pH 3.7

Serious events: 7 serious events

Other events: 213 other events

Deaths: 0 deaths

Patanase Vehicle, pH 7.0

Serious events: 14 serious events

Other events: 214 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	PATANASE n=421 participants at risk Two sprays in each nostril twice a day for up to 12 months	Patanase Vehicle, pH 3.7 n=417 participants at risk Two sprays in each nostril twice a day for up to 12 months	Patanase Vehicle, pH 7.0 n=422 participants at risk Two sprays in each nostril twice a day for up to 12 months
Respiratory, thoracic and mediastinal disorders Epistaxis	21.9% 92/421 • 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.	18.2% 76/417 • 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.	20.1% 85/422 • 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.
Nervous system disorders Headache	5.7% 24/421 • 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.	6.5% 27/417 • 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.	5.9% 25/422 • 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.
Injury, poisoning and procedural complications Injury	7.4% 31/421 • 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.	6.7% 28/417 • 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.	8.8% 37/422 • 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.
Respiratory, thoracic and mediastinal disorders Nasal ulcer	7.4% 31/421 • 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.	6.5% 27/417 • 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.	8.3% 35/422 • 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.
Infections and infestations Nasopharyngitis	11.9% 50/421 • 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.	12.2% 51/417 • 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.	11.4% 48/422 • 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.
Infections and infestations Rhinitis	12.1% 51/421 • 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.	14.1% 59/417 • 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.	14.5% 61/422 • 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.
Infections and infestations Sinusitis	13.1% 55/421 • 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.	11.5% 48/417 • 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.	11.6% 49/422 • 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.
Infections and infestations Upper respiratory tract infection	8.6% 36/421 • 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.	12.5% 52/417 • 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.	10.7% 45/422 • 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.

Additional Information

Terri Pasquine, Sr. Clinical Lead

Alcon Research

Phone: 817-551-4760

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Alcon reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER