The Study Will Evaluate the Efficacy of AZD5423 in Patients With Mild Asthma Challenged With an Inhaled Allergen

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Placebo; Drug: Budesonide 200 microgram; Drug: AZD5423

Study type: Interventional

Funder types: Industry

Identifiers

NCT01225549

D2340C00005

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy of AZD5423 in patients with mild asthma challenged with an inhaled allergen.

Enrollment: 27 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-60 years of age
• Pre-bronchodilatory FEV1 ≥70% of predicted normal allergic asthmatic with a history of episodic wheeze
• Positive allergen induced early and late airway bronchoconstriction showing ≥ 20% fall in FEV1 for the early and ≥ 15% for the late response
• Positive skin prick test to common aeroallergens

Exclusion criteria

• Any clinically significant disease or disorder
• Any clinically relevant abnormal finding at screening examinations
• Smoker or ex-smoker who has stopped smoking < 12 months prior to study start
• Worsening of asthma or respiratory infection within 6 weeks from visit 1
• Allergen-specific immunotherapy within 6 months prior to visit 1

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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27 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

AZD5423 75ug

Treatment:

Drug: Placebo

Drug: AZD5423

Drug: Placebo

2

Experimental group

Description:

AZD5423 300ug

Treatment:

Drug: Placebo

Drug: AZD5423

Drug: Placebo

3

Active Comparator group

Description:

Budesonide 200 microgram

Treatment:

Drug: Placebo

Drug: Budesonide 200 microgram

Drug: Placebo

4

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Drug: Placebo