Allergic Rhinitis - Both Persistent and Intermittent
Conditions
Interventions
Trade Name: Xyzal 5mg Tablets
Product Name: Xyzal 5mg Tablets
Pharmaceutical Form: Tablet
CAS Number: 130018-77-8
Current Sponsor code: Xyzal
Other descriptive name: levocetizine dihydrochloride
Conce
Sponsors
Research and Innovation Services
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed