Asthma MedDRA version: 13.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: AZD3199 Turbuhaler
Product Code: AZD3199 Turbuhaler
Pharmaceutical Form: Inhalation powder
CAS Number: 925244-40-2
Current Sponsor code: AZD3199 dihydrobromide
Other descriptive name: AZ
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Provision of signed and dated written informed consent prior to any study specific procedures 2) 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 3) Be a non-smoker or ex-smoker who has stopped smoking for >6 months prior to study start 4) A history of asthma for at least 6 months. 5) Body Mass Index (BMI) 19-30 kg/m2 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1) 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 2) 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 3) Prolonged QTcF > 450 msec or shortened QTcF <340 msec 4) History of alcohol/drug abuse or excessive intake of alcohol as judged by the Investigator 5) Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the pharmacokinetics and pharmacodynamics of single doses of dry powder inhalation formulations of AZD3199 administered via Single Inhalation Device (SID) compared to AZD3199 administered via Turbuhaler® and compared to placebo in patients with persistent asthma.;Secondary Objective: To investigate the safety and tolerability of different dry powder formulations of AZD3199 compared to placebo after single dose administration.;Primary end point(s): Forced Expiratory Volume in 1 second (FEV1): both the peak effect within 0-24 h post dose (Emax) and the trough effect measured 22-26 h post dose (E22-26 h);Timepoint(s) of evaluation of this end point: The peak effect within 0-24 h post dose (Emax) and the trough effect measured 22-26 h post dose (E22-26 h) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pulse Emax and E0-4 h Adverse Events (AEs), vital signs, ECG, FEV1, forced vital capacity (FVC) and safety laboratory variables AUC and Cmax ;Timepoint(s) of evaluation of this end point: Pulse Emax and E0-4 h = 0-4 hours post each single dose administration. Adverse Events (AEs), vital signs, ECG, FEV1, forced vital capacity (FVC) and safety laboratory variables = Frequent safety measurements during the study from screening until follow-up. AUC and Cmax = Pre-dose up until 120 hours post each single dose administration | — |
Countries
Sweden
Outcome results
None listed