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

Asthma Clinical Trial

Official title:

A Randomised, Double-blind, Double-dummy, Placebo-controlled, Multicentre, 6-way Crossover, Single-dose, Phase IIa Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Different Dry Powder Inhalation Formulations of AZD3199 Administered Via Single Inhalation Device Compared to AZD3199 Administered Via Turbuhaler™ Inhaler in Patients With Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01348139
• Other study ID #: D0570C00011
• Secondary ID: 2011-000133-37
• Status: Completed
• Phase: Phase 2
• First received: May 3, 2011
• Last updated: January 28, 2013
• Start date: May 2011
• Est. completion date: February 2012

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 ß2-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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• AZD3199
Inhaled via single inhaler device (SID)
• AZD3199
Inhaled via Turbuhaler inhaler

Other:
• AZD3199 Placebo
Inhaled via Turbuhaler inhaler and SID

Locations

Country	Name	City	State
Sweden	Research Site	Göteborg
Sweden	Research Site	Luleå
Sweden	Research Site	Lund

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emax: Maximum Value of FEV1 for Every Treatment Visits	Peak effect (Emax) within 0-24 hours of FEV1, for treatment visits 2 to 7.	0-24 hrs	No
Primary	E22-26h: The Average of the FEV1 Values Between 22 and 26 h for Every Treatment Visit	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.	22-26 hrs.	No
Secondary	tEmax: Time to Maximum Value of FEV1 for Every Treatment Visit	Time to peak effect (tEmax), within 0-24 hours of FEV1, for treatment visits 2 to 7.	0 - 24 hrs.	No
Secondary	E5min: The Value of FEV1 at 5 Min for Every Treatment Visit.	Onset of effect (E5min), observed at 5 min. FEV1 for treatment visits 2 to 7.	FEV1 at 5 min	No
Secondary	E0-24h: The Average of the FEV1 Values Between 0 and 24 h for Every Treatment Visit	Average effect over 0-24 hours of FEV1 (E0-24h), for treatment visits 2 to 7.	0 - 24 hrs	No
Secondary	Emax: Maximum Value of Pulse for Every Treatment Visits	Peak effect (Emax) within 0-4 hours of pulse, for treatment visits 2 to 7.	0 - 4 hrs.	No
Secondary	E0-4h: The Average of the Pulse Values Between 0 and 4 h for Every Treatment Visit	Average effect (E0-4h) of Pulse, for treatment visits 2 to 7.	0 - 4 hrs.	No
Secondary	Cmax: Maximum Plasma Concentration	Maximum plasma concentration (Cmax) for AZD3199 doses	0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.	No
Secondary	AUC: Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC),	Area under the plasma concentration-time curve from zero to infinity (AUC), for AZD3199 doses	0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.	No
Secondary	Tmax:Time to Maximum Plasma Concentration	Time to maximum plasma concentration (tmax), for AZD3199 doses	0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.	No
Secondary	t1/2 :Terminal Half-life	Terminal half-life (t1/2),for AZD3199 doses	0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.	No