Single-dose Crossover Study to Investigate Pharmacodynamics of AZD3199

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Asthma; Airway Obstruction

Treatments: Drug: AZD3199; Drug: Placebo; Drug: Formoterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00736489

D0570C00007

ToBe

Details and patient eligibility

About

The purpose of this study is to investigate the pharmacodynamics of single doses of AZD3199 in asthmatic patients.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Asthmatic patients with pre-bronchodilatory FEV1 above 60% of predicted normal and above 1.5 liters.
• Men and post-menopausal women above 18 years of age.
• Reversible airway obstruction in response to classical beta2-agonist (salbutamol)
• Non/ex-smokers

Exclusion criteria

• Any clinically significant disease or disorder other than asthma
• Any clinically relevant abnormal findings at screening examinations
• Treatment with systemic glucocorticosteroids within the past 30 days
• Inhaled corticosteroid use if dosing is not kept constant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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37 participants in 6 patient groups, including a placebo group

crossover dose 1

Experimental group

Description:

AZD3199 120 microgram

Treatment:

Drug: AZD3199

crossover dose 2

Experimental group

Description:

AZD3199 480 microgram

Treatment:

Drug: AZD3199

crossover dose 3

Experimental group

Description:

AZD3199 1920 microgram

Treatment:

Drug: AZD3199

crossover dose 4

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

crossover dose 5

Active Comparator group

Description:

Formoterol 9 microgram

Treatment:

Drug: Formoterol

crossover dose 6

Active Comparator group

Description:

Formoterol 36 microgram

Treatment:

Drug: Formoterol