Evaluation of the Pharmacokinetics and the Pharmacodynamics of Different Dry Powder Inhalation Formulations of AZD3199 in Patients With Asthma

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: AZD3199; Other: AZD3199 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01348139

D0570C00011

2011-000133-37 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of single doses of three different dry powder inhalation formulations of AZD3199 administered via Single Inhalation Device (SID) compared to AZD3199 administered via Turbuhaler™ Inhaler and compared to placebo in patients with persistent asthma.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of signed and dated written informed consent prior to any study specific procedures
• Men or women, age ≥ 18 years. Women must be of non-childbearing potential or stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue on the chosen contraceptive method throughout the study.
• Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to study start
• A history of asthma for at least 6 months.
• Body Mass Index (BMI) 19-30 kg/m2

Exclusion criteria

• Significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to β2-agonists in general or to AZD3199 and/or excipients
• Prolonged QTcF > 450 msec or shortened QTcF <340 msec
• History of alcohol/drug abuse or excessive intake of alcohol as judged by the Investigator
• Pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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39 participants in 6 patient groups, including a placebo group

1

Experimental group

Description:

AZD3199 800 µg inhaled via single inhaler device (SID), single dose

Treatment:

Drug: AZD3199

Drug: AZD3199

2

Experimental group

Description:

AZD3199 880 µg inhaled via SID, single dose

Treatment:

Drug: AZD3199

Drug: AZD3199

3

Experimental group

Description:

AZD3199 1400 µg inhaled via SID, single dose

Treatment:

Drug: AZD3199

Drug: AZD3199

4

Experimental group

Description:

AZD3199 300 µg inhaled via Turbuhaler inhaler, single dose

Treatment:

Drug: AZD3199

Drug: AZD3199

5

Experimental group

Description:

AZD3199 1200 µg inhaled via Turbuhaler inhaler, single dose

Treatment:

Drug: AZD3199

Drug: AZD3199

6

Placebo Comparator group

Description:

Placebo inhaled via Turbuhaler inhaler and SID, single dose

Treatment:

Other: AZD3199 Placebo