Cross-Over Study of the Decongestant Effect of Phenylephrine Compared With Placebo and Pseudoephedrine as Active Control in SAR Subjects Exposed to Pollen in the Vienna Challenge Chamber
- Conditions
- Seasonal Allergic Rhinitis
- Registration Number
- EUCTR2005-004309-27-AT
- Lead Sponsor
- Schering Plough Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 39
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method