Effects of Phenylephrine on Nasal Congestion in Participants With Seasonal Allergic Rhinitis (P08156 AM2)(Completed)
- Conditions
- Seasonal RhinitisRhinitis
- Interventions
- Registration Number
- NCT01330017
- Lead Sponsor
- Bayer
- Brief Summary
The trial will evaluate the nasal congestion symptom relief of the approved 10 mg phenylephrine (PE) dose and the higher 20 mg, 30 mg, and 40 mg PE doses compared with placebo in participants with histories of seasonal allergic rhinitis, using loratadine as background medication.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 539
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PE 10 mg Placebo - PE 10 mg Phenylephrine HCl - PE 10 mg Loratadine - PE 20 mg Phenylephrine HCl - PE 30 mg Phenylephrine HCl - PE 30 mg Placebo - PE 30 mg Loratadine - Placebo Placebo - PE 20 mg Placebo - PE 20 mg Loratadine - PE 40 mg Phenylephrine HCl - PE 40 mg Placebo - PE 40 mg Loratadine - Placebo Loratadine -
- Primary Outcome Measures
Name Time Method Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score Baseline, Day 7 The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. Participants rated congestion on a 4-point scale of severity from 0 (best) to 3 (worst), with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period. Baseline was defined as the average of the daily scores over the 4 consecutive 24-hour periods before randomization.
- Secondary Outcome Measures
Name Time Method Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period Baseline and Days 1, 2, 3, 4, 5, 6, and 7 Instantaneous assessment of nasal symptoms was performed once daily before the
morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.Change From Baseline for the Instantaneous Nasal Symptom Assessment Score at Day 7 Baseline, Day 7 The magnitude of effect was measured as the change from baseline for the instantaneous nasal symptom assessment score at Day 7. Instantaneous assessment of nasal symptoms was performed once daily before the morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.
Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period Baseline and Day 2, 3, 4, 5, 6, and 7 Instantaneous assessment of nasal symptoms was performed once daily before the
morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period Baseline and Days 2, 3, 4, 5, 6, and 7 The morning reflective nasal congestion score was captured in participant diaries just before the 8:00 am dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and it is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.
Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period Baseline and Days 1, 2, 3, 4, 5, 6, and 7 The evening reflective nasal congestion score was captured in participant diaries just before the 8;00 p.m. dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms.
Time to Maximal Effect Baseline up to Day 7 Time to maximal effect is defined as the earliest time that the nasal congestion symptom score demonstrates the greatest numerical difference from the placebo in change from baseline. The mean change from baseline scores for a treatment arm and for the placebo arm at each day and timepoint of the treatment period (Day 1 morn, Day 1 eve, etc) were calculated. Then the difference between the placebo and treatment arm means at each day/timepoint of the treatment period was calculated and recorded the day/timepoint that the difference between the treatment arm and the placebo was highest.
Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period Baseline and Days 1, 2, 3, 4, 5, 6, and 7 The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period.