Asthma MedDRA version: 18.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Interferon beta-1a Nebuliser solution 48 µg/mL
Product Code: Interferon beta-1a Nebuliser solution 48 µg/mL
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Interferon beta-1
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study patients should fulfil the following criteria: 1.Provision of signed and dated written informed consent prior to any study specific procedures 2.Male or female aged 18 and above at the time of screening 3.History of physician-diagnosed asthma requiring treatment with medium-to-high dose ICS (>250 µg fluticasone dry powder formulation equivalents total daily dose, as defined in GINA 2014; see CSP App. G) and a second controller medication as recommended in the GINA guidelines (ie, LABA or leukotriene receptor antagonist). The medium or high dose ICS plus LABA can be any combination inhaler or 2 separate inhalers. Patients must have taken ICS (>250 µg fluticasone or the equivalent daily) plus second controller medication for at least 12 months prior to the date the informed consent is obtained, with or without another controller such as OCS, theophylline, tiotropium, or leukotriene receptor antagonists. The maintenance treatment must have been kept at the same or at ahigher level these last months. 4.Proof of post-bronchodilator reversibility in FEV1 of =12% and =200 mL (Pellegrino et al 2005) documented within 5 years prior to Visit 1, or proof of a positive response to a methacholine or histamine challenge (a decrease in FEV1 by 20% [PC20] at =8 mg/mL) performed according to ATS/ERS guidelines (American Thoracic Society 2000) or proof of positive response to mannitol challenge (a descrease in FEV1 by 15%[PD15] at <=635 mg)(Anderson et al 2009) documented within 5 years prior to Visit 1. If historical documentation is not available, reversibility or proof of a positive response to a methacholine, histamine or mannitol challenge must be demonstrated and documented at Visit 1 5.Must answer “Yes” to the question “Does a cold or flu make your asthma worse?” 6.To have had at least two documented severe asthma exacerbations within the last 24 months that were suspected by the patient to have been caused by a cold or flu and To have had at least one documented severe asthma exacerbation within the last 12 months that was suspected by the patient to have been caused by a cold or flu A severe asthma exacerbation is defined as worsening of asthma symptoms and: -Use of systemic corticosteroids (or a temporary increase of at least 2-fold in a stable oral corticosteroid background dose) for at least three days and/or - An unscheduled visit or emergency room visit due to asthma symptoms that requires at least one dose of systemic corticosteroids and/or - An in-patient hospitalization due to asthma requiring at least one dose of systemic corticosteroids The below defines what is acceptable to document exacerbations in this study - Discharge summaries from a hospital, emergency department, or an urgent care facility indicating that a subject was hospitalized/treated with systemic steroids for an asthma exacerbation. - Signed and dated notes from a referring physician, including information regarding diagnosis and treatment of an exacerbation with systemic steroids. -Patients can provide evidence of prescriptions for systemic steroids used during an exacerbation. -A documented conversation between the treating/referral physician or nurse/nurse practitioner certifying that a patient was treated for an exacerbation with steroids at their clinic or under their supervision. The dates (month/year) of the exacerbations and verbal confirmation that appropriate prescriptions were provided is necessary. This option should be used only
Exclusion criteria
Exclusion criteria: Patients should not enter if any exclusion criteria are fulfilled: 1.Involvement in planning and/or conduct of the study(applies to both AZ staff and staff at third party vendors or staff at the study sites) 2.Previous randomization to treatment in present study 3.Any condition, including findings in the medical history or in the pre-study assessm. that, in the opinion of the Investigator constitutes a risk or a contraindication for the participation of the pat in the study 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=150mmHg -In patients >= 60 years old, systolic blood pressure 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, 10.Prolonged QTcF >450 ms (for both gender) or shortened QTcF 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 ide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of inhaled Interferon beta-1a compared to placebo in preventing severe exacerbations during the 14 days of treatment following onset of an upper respiratory tract infection in asthmatic patients, on top of their regular asthma maintenance treatment.;Secondary Objective: To evaluate the preventive or attenuating effect of inhaled Interferon beta-1a compared to placebo on deterioration of secondary efficacy endpoints during and after upper respiratory tract infection. Analysed variables will include: - Occurrence of severe exacerbations with onset during day 1-30 after start of treatment - Occurrence of moderate exacerbations with onset during day 1-30 after start of treatment - Time to severe exacerbation - Time to moderate exacerbation - Change from treatment baseline in Patient reported outcomes - (a) Asthma control as measured by ACQ-6 - (b) Day-time and night-time asthma symptom score and night-time awakenings as determined by area under the curve (AUC) over day 1-14 - (c) Health-related quality of life as measured by AQLQ(S) - Day-time and night-time reliever medication use as determined by AUC over day 1-14 as change from the treatment baseline level - Lung function, ie morning and evening PEF and FEV1;Primary end point(s): Number of severe exacerbations (during 14 days of treatment) Duration of severe exacerbation ;Timepoint(s) of evaluation of this end point: During the 14 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of moderate exacerbations (during 14 days of treatment) Number of severe exacerbations (during day 1-30 after start of treatment) Number of moderate exacerbations (during day 1-30 after start of treatment) Time to sever exacerbation Time to exacerbation (moderate or severee) Change from treatment baseline in Patient reported outcomes in the following variables: - Asthma control as measured by ACQ-6 - Day-time and night-time asthma symptom score and night-time awakenings as determined by area under the curve (AUC) over day 1-14 - Health-related quality of life as measured by AQLQ(S) Day-time and night-time reliever medication use as determined by AUC over day 1-14 as change from the treatment baseline level Lung function ie, PEF, FEV1 Morning and evening peak expiratory flow (PEF) and forced expiratory volume in 1 second (FEV1) measured daily at home, as determined by AUC over day 1-14 as change from the baseline level ;Timepoint(s) of evaluation of this end point: During the 14 days of treatment and for some up to 30 days after start of treatment | — |
Countries
Argentina, Australia, Colombia, France, Korea, Democratic People's Republic of, Spain, United Kingdom
Contacts
Public ContactInformation Centre
AstraZeneca AB
Outcome results
None listed