The Tolerability and Effects of AZD8848 in Allergic Asthma Subjects Challenged With Inhaled Allergen

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Allergic Asthma

Treatments: Drug: Placebo; Drug: AZD8848

Study type: Interventional

Funder types: Industry

Identifiers

NCT00999466

D0540C00004

Details and patient eligibility

About

AZD8848 is a new drug that is being tested for the treatment of asthma and allergic rhinitis (hayfever). This study will be in two parts and will include 59 asthmatic patients in total. The first part will investigate the tolerability and safety of AZD8848 while the second part will investigate both the therapeutic effect of AZD8848 and how well patients tolerate the drug.

Enrollment: 60 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• FEV1 > 70 % of predicted normal pre-bronchodilator
• Documented history of asthma
• Presence of allergic sensitivity

Exclusion criteria

• Clinically relevant disease and/or abnormality (past or present), which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient's ability to participate in the study.
• Symptomatic allergic rhinitis
• Any clinical relevant abnormal findings in physical examination or assessment which may put the patient at risk because of participation in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

AZD8848 (30 μg PILOT part and 60 μg MAIN part)

Treatment:

Drug: AZD8848

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo