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

• Conditions: This is a Phase II trial (Proof of Principle) in volunteer rhinitis subjects utilising a seasonal model of rhinitis and challenge agent

• Registration Number: EUCTR2005-002805-21-SE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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
7. Reaction to a nasal allergen challenge resulting in at least five sneezes and/or
recorded score of = 2 on a scale from 0-3 in either of the symptoms nasal blockage
and/or runny nose

For inclusion in the genetic part of the study the subjects must fulfil the following criterion:
1. Provision of informed consent for genetic research

If a subject declines to participate in the genetic research, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent.

Are the trial subjects under 18?
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)
F.1.3.1 Number of subjects for this age range

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.
5. Any upper respiratory tract infection (bacterial, viral or fungal infections of the
airways) 2 weeks prior to Visit 1 being symptomatic enough to affect study
conduct or the well-being of the subject as judged by the investigator
6. Topical glucocorticosteroid treatment within 1 month prior to Visit 1
7. Systemic glucocorticosteroid therapy for any reason during 6 weeks prior to Visit 1
8. Antihistamine treatment within 1 week prior to Visit 1
9. Subjects on immunotherapy for seasonal allergies
10. BMI < 18 kg/m3 or body weight below 65 kg
11. A marked baseline prolongation of QT/QTc (eg repeated demonstration of a QTc
interval >450 ms for females and >430 ms for males
12. A history of additional risk factors for Torsade de pointes (eg heart failure,
hypokalemia, family history of Long QT syndrome)
13. The use of concomitant medications that prolong the QT/QTc interval.
14. Involvement in the planning and conduct of the study (applies to both AstraZeneca
staff or staff at the study site)
15. Participation in another clinical study within 1 month prior to Visit 1
16. Planned hospitalisation during the course of the study
17. Previous randomization in the present study
18. Past (within 1 year) or present alcohol or drug abuse
19. Suspected poor capability, as judged by the investigator, to follow instructions of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified