A Study in Asthma Patients to Evaluate Efficacy, Safety and Tolerability of 14 Days Once Daily Inhaled Interferon Beta-1a After the Onset of Symptoms of an Upper Respiratory Tract Infection

1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and staff at third party vendors or staff at the study sites)

2. Previous randomization to treatment in the present study

3. Any condition, including findings in the medical history or in the pre-study assessments that, in the opinion of the Investigator, constitutes a risk or a contraindication for the participation of the patient in the study or that could interfere with the study objectives, conduct or evaluation

4. Lung disease other than asthma (eg, chronic obstructive pulmonary disease, cystic fibrosis, allergic bronchopulmonary aspergillosis, active tuberculosis). Patients with CT or chest X-ray findings indicating bronchiectasis which in the opinion of the Investigator are not clinically significant may be enrolled at the discretion of the Investigator

5. Patients with ≥4 severe exacerbations during the last 12 months that the patient suspected were triggered by something else than an upper respiratory tract infection

6. Current participation in another clinical trial or participation in a clinical trial where the patient has received a dose of a test product (IMP) within 12 weeks prior to entry into the study for small molecules and within 12 months prior to entry into the study for biologicals, or 5 times the half-life (whichever is the longest) of the biologic or small molecule IMP

7. Patients who currently have, or have had within the past 3 months, any significant underlying medical condition(s) that could impact interpretation of results eg, infections, haematological disease, malignancy, renal, hepatic, coronary heart disease or other cardiovascular disease, including arrhythmias, endocrinological or gastrointestinal disease

8. Abnormal vital signs, after at least 10 minutes supine rest, defined as any of the following:

* In patients \< 60 years old, systolic blood pressure \<90 mmHg or ≥150 mmHg

* In patients ≥ 60 years old, systolic blood pressure \<90 mmHg or ≥160 mmHg

* Diastolic blood pressure \<50 mmHg or ≥100 mmHg

* HR \<45 or \>95 beats per minute

9. Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, as considered by the Investigator, may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology (particularly in the protocol defined primary lead) or left ventricular hypertrophy

10. Prolonged QTcF \>450 ms (for both gender) or shortened QTcF \<340 ms or family history of long QT syndrome

11. PR(PQ) interval shortening \<120ms (PR\<120 ms but \>110 ms is acceptable if there is no evidence of ventricular pre-excitation).

12. PR(PQ) interval prolongation (\>240ms), intermittent second or third degree AV block, or AV dissociation

13. QRS duration \>120ms including persistent or intermittent bundle branch block

14. Patients with implantable cardiac defibrillator (ICD) or a permanent pacemaker and patients with symptomatic ventricular and / or atrial tachyarrhythmias

15. Patients with unstable angina pectoris or stable angina pectoris classified higher than Canadian Cardiovascular Society (CSS) class II or a myocardial infarction or stroke within 6 months

16. History of hospitalization within 12 months caused by heart failure or a diagnosis of heart failure higher than New York Heart Association (NYHA) class II

17. History of hypersensitivity to natural or recombinant Interferon beta-1a or to any of the drug preparation excipients

18. Received any marketed biologic agent (eg, omalizumab) within 12 months or 5 times the half-life (whichever is the longer) of the agent prior to enrolment

19. Significant history of depressive disorder or suicidal ideation. Specifically; individuals with current severe depression (ie, a low mood, which pervades all aspects of life and an inability to experience pleasure in activities that formerly were enjoyed); individuals with a past history of depression that required hospitalization or referral to psychiatric services in the past 5 years; individuals who currently feel suicidal or have attempted suicide in the past

20. History of epilepsy or seizures after the age of 5 years, other than febrile childhood seizure(s)

21. History of drug or alcohol abuse within 12 months prior to enrolment

22. Patients who have hepatic serum enzyme levels ≥2.5 times the normal range

23. Positive test for serum hepatitis B surface antigen, hepatitis C antibody, or HIV

24. Patients with a smoking history of ≥20 pack-years (1 pack year = 20 cigarettes smoked per day for one year)

25. Female who is breast-feeding, pregnant (verified by urine dipstick pregnancy test) or intends to become pregnant during the study

26. Patients who are unable to demonstrate an acceptable spirometry technique

27. Patients that have previously been included in studies evaluating the investigational medicinal product

What this study is about