A phase II, double-blind, placebo-controlled, randomised, 6-waycross-over, single-dose study to investigate the local and systemic effectsof 3 doses of inhaled AZD3199 (a ß2-agonist) compared to formoterol inasthmatic patients.

Phase 1

Conditions: Asthma
MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma

Registration Number: EUCTR2008-001724-32-FI

Lead Sponsor: AstraZeneca AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 0

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

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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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