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

Phase 2

Completed

Conditions: Asthma

Interventions: Drug: AZD3199
Other: AZD3199 Placebo

Registration Number: NCT01348139

Lead Sponsor: AstraZeneca

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 39

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	AZD3199	AZD3199 800 µg inhaled via single inhaler device (SID), single dose
2	AZD3199	AZD3199 880 µg inhaled via SID, single dose
3	AZD3199	AZD3199 1400 µg inhaled via SID, single dose
4	AZD3199	AZD3199 300 µg inhaled via Turbuhaler inhaler, single dose
5	AZD3199	AZD3199 1200 µg inhaled via Turbuhaler inhaler, single dose
6	AZD3199 Placebo	Placebo inhaled via Turbuhaler inhaler and SID, single dose

Primary Outcome Measures

Name	Time	Method
Emax: Maximum Value of FEV1 for Every Treatment Visits	0-24 hrs	Peak effect (Emax) within 0-24 hours of FEV1, for treatment visits 2 to 7.
E22-26h: The Average of the FEV1 Values Between 22 and 26 h for Every Treatment Visit	22-26 hrs.	Trough effect (E22-26h) will be computed from the repeated measurements collected after each single dose during 22-26 hours of FEV1 from visit 2 to 7.

Secondary Outcome Measures

Name	Time	Method
tEmax: Time to Maximum Value of FEV1 for Every Treatment Visit	0 - 24 hrs.	Time to peak effect (tEmax), within 0-24 hours of FEV1, for treatment visits 2 to 7.
E5min: The Value of FEV1 at 5 Min for Every Treatment Visit.	FEV1 at 5 min	Onset of effect (E5min), observed at 5 min. FEV1 for treatment visits 2 to 7.
E0-24h: The Average of the FEV1 Values Between 0 and 24 h for Every Treatment Visit	0 - 24 hrs	Average effect over 0-24 hours of FEV1 (E0-24h), for treatment visits 2 to 7.
Emax: Maximum Value of Pulse for Every Treatment Visits	0 - 4 hrs.	Peak effect (Emax) within 0-4 hours of pulse, for treatment visits 2 to 7.
E0-4h: The Average of the Pulse Values Between 0 and 4 h for Every Treatment Visit	0 - 4 hrs.	Average effect (E0-4h) of Pulse, for treatment visits 2 to 7.
Cmax: Maximum Plasma Concentration	0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.	Maximum plasma concentration (Cmax) for AZD3199 doses
AUC: Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC),	0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.	Area under the plasma concentration-time curve from zero to infinity (AUC), for AZD3199 doses
Tmax:Time to Maximum Plasma Concentration	0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.	Time to maximum plasma concentration (tmax), for AZD3199 doses
t1/2 :Terminal Half-life	0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.	Terminal half-life (t1/2),for AZD3199 doses