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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Allergic Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

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

Group Type EXPERIMENTAL

AZD8848

Intervention Type DRUG

Nasal spray, solution 0.6mg/ mL. Once weekly for 7 weeks, 8 doses in total.

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Nasal spray, solution. Once weekly for 7 weeks, 8 doses in total.

Interventions

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AZD8848

Nasal spray, solution 0.6mg/ mL. Once weekly for 7 weeks, 8 doses in total.

Intervention Type DRUG

Placebo

Nasal spray, solution. Once weekly for 7 weeks, 8 doses in total.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No