ALAP-1 for the attenuation of nasal provocation with histamine in seasonal allergic rhinitis: a randomised, double-blind, placebo-controlled, three-day dosing, cross-over study and dose finding one month cross-over study
Completed
- Conditions
- Seasonal allergic rhinitisRespiratory
- Registration Number
- ISRCTN83077547
- Lead Sponsor
- Radix Bioscience (USA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
1. Age 18 - 59 years, either sex
2. A history of seasonal allergic rhinitis
Exclusion Criteria
1. Atrophic rhinitis
2. Rhinitis medicamentosa
3. Nasal polyps
4. Septal deviation
5. Active bacterial or viral sinusitis
6. Severe asthma
7. Peptic ulcer disease or active gastroesophageal reflux disease (GERD)
8. History of anaphylaxis to any allergen
9. Pregnancy
10. Active bacterial or viral rhinitis
11. Nasal surgery within the last eight weeks
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Peak nasal inspiratory flow meter, measured at 0, 10, 20, 30, 45 and 60 minutes post-histamine challenge on the study visit days.
- Secondary Outcome Measures
Name Time Method Sneeze score, measured at 0, 10, 20, 30, 45 and 60 minutes post-histamine challenge on the study visit days.