Nasal Congestion
Conditions
Keywords
Seasonal Allergic Rhinitis, nasal congestion
Brief summary
The study was to determine if the drug worked to relieve nasal congestion experienced by people with seasonal allergies.
Detailed description
Subjects who met the inclusion/exclusion criteria were enrolled into the placebo run-in phase of the study on Day -7 (prerandomization, Visit 1). Baseline symptom scores were established during this run-in phase. Subjects with moderate nasal congestion who took at least 80% of their study medication during the run-in phase were eligible for enrollment in the two-week double-blind phase of the study and were randomized on Day 1 (randomization, Visit 2). They were treated for two weeks with their assigned medication. The severity of signs/symptoms were evaluated by the subjects every morning and night and by the investigator at each visit on Day 7 and Day 14. In addition, the subject and investigator provided a global evaluation of response to treatment on Day 7 and Day 14. Safety was evaluated by adverse events reported during the study, vital signs, and the incidence of somnolence.
Interventions
DRUGDiphenhydramine 50 mg
Three times daily: two diphenhydramine 25 mg capsules Twice daily: one pseudoephedrine-matching placebo tablet
Three times daily: one diphenhydramine 25 mg capsule and one diphenhydramine-matching placebo capsule Twice daily: one pseudoephedrine-matching placebo tablet
DRUGPseudoephedrine 120 mg
Three times daily: two diphenhydramine-matching placebo capsules Twice daily: one pseudoephedrine 120 mg tablet
Sponsors
Johnson & Johnson Consumer and Personal Products Worldwide
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* otherwise healthy males and females * 12 to 65 years of age * hypersensitivity to specific pollens for a minimum of 2 years prior to study start * appropriate SAR sign/symptoms scores
Exclusion criteria
* pregnancy, lactation and contraception issues * contraindicated medications or therapies * evidence of clinical, dietary, lifestyle or psychiatric issues, which in the opinion of the investigator, could increase the risk to the subject or research staff, or interfere with the interpretation of study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the subject's mean reflective nasal congestion/stuffiness symptom score | every 12-hours over the 14-day treatment period |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in the subject's mean instantaneous TNS Score | 14 Days |
| Change from baseline in the subject's mean reflective Total SAR Symptom (TSS) Score | 14 Days |
| Change from baseline in the subject's mean instantaneous TSS Score | 14 Days |
| Change from baseline in the subject's mean reflective score for each of the seven remaining individual SAR symptoms, excluding nasal congestion/stuffiness | 14 Days |
| Change from baseline in the subject's mean instantaneous score for each of the eight individual SAR symptoms | 14 Days |
| Onset of action for diphenhydramine treatment for nasal congestion/stuffiness was determined by comparing the change from baseline in the subject's instantaneous nasal congestion/stuffiness scores for diphenhydramine versus placebo | taken at 15, 30, 60 and 90 minutes after the initial dose. Baseline was the score taken just prior to the initial dose. |
| Onset of action for diphenhydramine treatment for allergic rhinitis symptoms was determined by comparing the change from baseline in the subject's instantaneous TNS scores for diphenhydramine versus placebo | taken at 15, 30, 60 and 90 minutes after the initial dose. Baseline was the score taken just prior to the initial dose |
| Duration of action for diphenhydramine for treatment of nasal congestion/stuffiness was evaluated by comparing the change from baseline in the subject's mean instantaneous nasal congestion/stuffiness scores for diphenhydramine versus placebo | taken at the six-hour trough (just prior to the 8:00 pm dose) and the 12-hour trough (just prior to the 8:00 am dose) |
| Duration of action for diphenhydramine for treatment of allergic rhinitis symptoms was evaluated by comparing the change from baseline in the subject's mean instantaneous TNS scores for diphenhydramine versus placebo | taken at the six-hour trough (just prior to the 8:00 pm dose) and the 12-hour trough (just prior to the 8:00 am dose) |
| Change from baseline in the subject's mean reflective Total Nasal Symptom (TNS) Score | 14 Days |
| Subject's global evaluation of response to treatment | at Visits 3 and 4, analyzed separately at each visit |
| Change from baseline in the Investigator's TNS score | at Visits 3 and 4, analyzed separately for each visit. Baseline was the score at Visit 1 |
| Change from baseline in the Investigator's TSS score | at Visits 3 and 4, analyzed separately for each visit. Baseline was the score at Visit 1 |
| Change from baseline for each of the eight individual Investigator's SAR symptoms | at Visits 3 and 4, analyzed separately for each visit. Baseline was the score at Visit 1 |
| Investigator's global evaluation of the subject's response to treatment | at Visits 3 and 4, analyzed separately for each visit |
| Number and percentage of subjects experiencing adverse events | Duration of study |
| Change from baseline and potentially clinically important vital signs (systolic and diastolic blood pressure, pulse, and respiratory rate) | Duration of study |
| Occurrence of somnolence | Overall and weekly |
| Time to maximal effect was assessed by a by-day analysis of the primary efficacy endpoint and select secondary endpoints | 14 Days |
Countries
United States
Outcome results
None listed