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Clinical Trials/EUCTR2005-002805-21-SE
EUCTR2005-002805-21-SE
Active, not recruiting
Not Applicable

A randomized, double-blind, placebo controlled, three-way crossover study exploring the efficacy of AZD3778 compared with placebo and an oral antihistamine (loratadine) in a model of seasonal allergic rhinitis - N/A

AstraZeneca AB0 sitesAugust 1, 2005
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DrugsLoratadine Biochemie

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
AstraZeneca AB
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 1, 2005
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •For inclusion in the study subjects must fulfil all of the following criteria:
  • •1\. Be willing and able to comply with study procedures and provide informed consent
  • •2\. Men and post\-menopausal or surgically sterilised women aged 18 to 60 years inclusive, (women will be considered post\-menopausal if they have been amenorrheic for 12 months and FSH plasma concentration is within the post
  • •menopausal range as defined by the laboratory)
  • •3\. A clinical diagnosis of birch and/or timothy grass pollen induced seasonal allergic
  • •rhinitis for at least the previous 2 years
  • •4\. The presence of allergic sensitivity to birch and /or timothy grass pollen verified by
  • •a positive skin prick test documented within the previous 24 months or at Visit 1
  • •5\. Asymptomatic subjects out of season, as judged by the investigator
  • •6\. Subjects with need of treatment for their nasal symptoms during the pollen season

Exclusion Criteria

  • •Any of the following is regarded as a criterion for exclusion from the study:
  • •1\. Any clinically relevant disease and /or abnormality which in the opinion of the
  • •investigator, either put the subject at risk because of participation in the study or
  • •influence the results of the study or the subjects ability to participate in the study.
  • •2\. Subjects with structural abnormalities of the nose or nasal disorder symptomatic
  • •enough to cause significant nasal obstruction as judged by the investigator
  • •3\. Have a clinical diagnosis of asthma
  • •4\. Have perennial allergic or non\-allergic rhinitis except for cat and dog sensitivity
  • •under the condition that these subjects will not be exposed to cat and dogs during
  • •the study period.

Outcomes

Primary Outcomes

Not specified

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