Clinical trial NCT01348139: Evaluation of the Pharmacokinetics and the Pharmacodynamics of Different Dry Powder Inhalation Formulations of AZD3199 in Patients With Asthma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
patients
lung function
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-05-05
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Emax: Maximum Value of FEV1 for Every Treatment Visits
timeFrame: 0-24 hrs
measure: E22-26h: The Average of the FEV1 Values Between 22 and 26 h for Every Treatment Visit
timeFrame: 22-26 hrs.
Secondary outcomes:
measure: tEmax: Time to Maximum Value of FEV1 for Every Treatment Visit
timeFrame: 0 - 24 hrs.
measure: E5min: The Value of FEV1 at 5 Min for Every Treatment Visit.
timeFrame: FEV1 at 5 min
measure: E0-24h: The Average of the FEV1 Values Between 0 and 24 h for Every Treatment Visit
timeFrame: 0 - 24 hrs
measure: Emax: Maximum Value of Pulse for Every Treatment Visits
timeFrame: 0 - 4 hrs.
measure: E0-4h: The Average of the Pulse Values Between 0 and 4 h for Every Treatment Visit
timeFrame: 0 - 4 hrs.
measure: Cmax: Maximum Plasma Concentration
timeFrame: 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.
measure: AUC: Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUC),
timeFrame: 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.
measure: Tmax:Time to Maximum Plasma Concentration
timeFrame: 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.
measure: t1/2 :Terminal Half-life
timeFrame: 0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Research Site
city: Luleå
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
Study officials:
References: