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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,260
Two sprays in each nostril twice a day (morning and evening) for up to 12 months
Two sprays in each nostril twice a day (morning and evening) for up to 12 months
Two sprays in each nostril twice a day (morning and evening) for up to 12 months
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States
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)
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
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)
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)
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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)
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)