A Placebo Controlled Trial to Evaluate The Effects of Levocetirizine on Nasal Allergen Challenge And Adenosine Monophosphate Challenge In Patients with Intermittent and Persistent Allergic Rhinitis - AMP - Allerge
Phase 1
- Conditions
- Allergic Rhinitis - Both Persistent and Intermittent
- Registration Number
- EUCTR2004-000683-27-GB
- Lead Sponsor
- Research and Innovation Services
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Male or Female Participants 16-75.
Participants with persistent allergic rhinitis must react to house dust mite on skin prick testing.
Participants with intermittent allergic rhinitis must react to grass or tree pollen on skin prick testing.
Are the trial subjects under 18? yes
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) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Asthmatics with an FEV1 < 60% predicted, or a recent chest infection or exacerbation.
Pregnant or breastfeeding mothers, or those taking inadequate contraceptive measures.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To further validate adenosine monophosphate challenge as a measurement of disease activity in allergic rhinitis, by making a comparison to the better established, but less safe allergen challenge standard.;Secondary Objective: Obtaining efficacy data on levocetirizine when measured in terms of attenuation of response to nasal adenosine monophosphate challenge.;Primary end point(s): Provocation concentration of adenosine monophosphate to induce a 20% drop in peak nasal inspiratory flow rates will be compared to the same for allergen challenge.
- Secondary Outcome Measures
Name Time Method