Asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Code: AZD3199 dihydrobromide Turbuhaler
Pharmaceutical Form: Inhalation powder
CAS Number: 925244-40-2
Current Sponsor code: AZD3199 dihydrobromide
Concentration unit: µg microgram(s)
Concentr
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study patients must fulfil the following criteria: 1. Provision of informed consent prior to any study specific procedures. 2. Be aged 18 years or above. 3. Men or post-menopausal (defined as amenorrheic for 12 months and folliclestimulating hormone (FSH) plasma concentration within the post-menopausal range as defined by the laboratory) or surgically sterile female patients. 4. Be non-smoker or ex-smoker who has stopped smoking for >6 months prior to study start and have a smoking history of not more than 15 pack years. 5. A history of asthma for at least 6 months. Asthma is defined according to the Global initiative for asthma (GINA 2007). 6. Pre-bronchodilator FEV1 equal to or above 60% of predicted normal value and equal to or above 1.5 L. 7. A stepwise reversible airway obstruction. A minimum of 5% units additional increase from first dose and a total of at least 15% increase in FEV1 are required. 8. Be able to inhale from the study devices. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients must not enter the study if any of the following exclusion criteria are fulfilled: 1. Any clinically significant disease or disorder (e.g. cardiovascular, pulmonary other than asthma, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment,) 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. Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs, ECG or lung function at baseline, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study. 3. QTcF >450 ms or QT >500 ms or other abnormality in ECG making interpretation more difficult, as judged by the investigator. 4. History of ischemic heart disease or heart failure. History of recurrent or current clinically significant arrhytmia or ECG abnormality as judged by the investigator. 5. Treatment with systemic glucocorticosteroids within 30 days prior to the study. 6. A definite or suspected personal history of intolerance or hypersensivity to drugs and/or their excipients, judged to be clinically relevant by the investigator. 7. Donation of blood within 3 months or donation of plasma within 14 days prior to Visit 1. 8. History of, or current alcohol or drug abuse, as judged by the investigator. 9. A suspected/manifested infection according to WHO risk classification 2, 3 or 4. 10. Positive results on screening tests for hepatitis B and/or C and/or HIV . 11. Previous randomisation to treatment in the present study. 12. Participation in another investigational drug study within 3 months before Visit 2. 13. Planned in-patient surgery, dental procedure or hospitalisation during the study. 14. Patients who, in the opinion of the investigator should not participate in the study. 15. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): • Pharmacodynamics: FEV1 Potassium concentration QTc and heart rate Pulse and blood pressure Tremor and palpitations • Safety: Adverse events Clinical laboratory assessments Physical examination • Pharmacokinetics: Plasma concentrations of AZD3199;Main Objective: The primary objective of the study is to investigate the pharmacodynamics of AZD3199 inhaled via Turbuhaler compared to placebo and inhaled formoterol. The primary variable for local pulmonary effect is Forced Expiratory Volume in 1 second (FEV1) and the primary variable for systemically mediated effect is potassium concentration. Heart rate, QTc, pulse, blood pressure, tremor and palpitations constitute secondary variables for systemically mediated effects.;Secondary Objective: The secondary objectives of the study are: - To investigate the safety of single-doses of AZD3199 by assessment of incidence and nature of adverse events (AEs), clinical laboratory assessments and physical examination. - To investigate drug exposure of AZD3199, by assessment of drug concentration in plasma and calculated pharmacokinetic (PK) parameters. | — |
Countries
Denmark, Finland, Sweden
Outcome results
None listed