Seasonal Allergic Rhinitis
Conditions
Interventions
Trade Name: (Non Drowsy Sudafed® Decongestant Tablets
Product Name: pseudoephedrine hydrochloride, 60 mg
Product Code: PSE
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Capsule*
Rout
Sponsors
Schering Plough Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Skin test positive for the grass pollen allergen used in the chamber at screening or within the prior 12 months. 2. A negative urine pregnancy test at screening and at monthly intervals for female subjects of childbearing potential. 3. The following minimum scores at some point during each of the 120-minute screening periods challenge sessions: a. nasal congestion scoreof at least 2 (moderate) b. total nasal symptoms score of at least 6 c. total non-nasal symptoms score of at least 2 4. Freedom from any clinically significant disease, other than SAR, that would interfere with the study evaluations. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. An upper or lower respiratory tract infection within 4 weeks before screening. 2. Dependence upon nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids, in the opinion of the investigator. 3. A known potential for hypersensitivity, allergy, or idiosyncratic reaction to the study drug or excipients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the effect of phenylephrine 12 mg immediate-release tablet on nasal congestion compared with that of placebo in subjects with seasonal allergic rhinitis (SAR) who have been exposed to pollen in the Vienna Challenge Chamber (VCC). Pseudoephedrine 60 mg immediate-release tablet will be included in the study as an active arm.;Secondary Objective: The key secondary objective is to estimate the effect of phenylephrine 12 mg and PSE 60 mg on nasal congestion over the 7.5 hour observaton period relative to placebo. Another secondary objective is to evaluate the safety profile of post dose adverse events and vitals signs compared with predose evaluations. Postdose blood pressure and pulse will be collected hourly and at final time point.;Primary end point(s): The primary efficacy parameter is the subjectively evaluated nasal decongestant effect expressed as an average change from baseline over the 7.5-hour evaluation period. The primary comparison for this variable is phenylephrine 12 mg versus placebo. | — |
Countries
Austria
Outcome results
None listed