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
Overview
- Phase
- Phase 2
- Intervention
- AZD3199
- Conditions
- Asthma
- Sponsor
- AstraZeneca
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Emax: Maximum Value of FEV1 for Every Treatment Visits
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
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
Arms & Interventions
1
AZD3199 800 µg inhaled via single inhaler device (SID), single dose
Intervention: AZD3199
2
AZD3199 880 µg inhaled via SID, single dose
Intervention: AZD3199
3
AZD3199 1400 µg inhaled via SID, single dose
Intervention: AZD3199
4
AZD3199 300 µg inhaled via Turbuhaler inhaler, single dose
Intervention: AZD3199
5
AZD3199 1200 µg inhaled via Turbuhaler inhaler, single dose
Intervention: AZD3199
6
Placebo inhaled via Turbuhaler inhaler and SID, single dose
Intervention: AZD3199 Placebo
Outcomes
Primary Outcomes
Emax: Maximum Value of FEV1 for Every Treatment Visits
Time Frame: 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
Time Frame: 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 Outcomes
- 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.)
- tEmax: Time to Maximum Value of FEV1 for Every Treatment Visit(0 - 24 hrs.)
- E5min: The Value of FEV1 at 5 Min for Every Treatment Visit.(FEV1 at 5 min)
- E0-24h: The Average of the FEV1 Values Between 0 and 24 h for Every Treatment Visit(0 - 24 hrs)
- Emax: Maximum Value of Pulse for Every Treatment Visits(0 - 4 hrs.)
- E0-4h: The Average of the Pulse Values Between 0 and 4 h for Every Treatment Visit(0 - 4 hrs.)
- Cmax: Maximum Plasma Concentration(0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.)
- 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.)
- t1/2 :Terminal Half-life(0 - 120 hrs for first two treatment visit 2 and 3 and 0 - 48 hrs for other treatment visits.)