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A study to investigate if inhaled Interferon beta-1a is safe and tolerated, and can prevent or reduce the severity of asthma attacks when administered to asthma patients at the onset of symptoms of common cold or influenza
The study will consist of a Pre-Treatment Phase followed by a Treatment Phase. Patients are screened and enter the Pre-Treatment phase where they remain until they develop symptoms of a common cold or the flu. During this Pre-Treatment Phase patients will be asked daily if they think they have a common cold or the flu. When the patient answers yes to the question that he/she is coming down with a common cold or the flu, arrangements are made to evaluate the patient at the study site and, if eligible, enters the Treatment Phase. Baseline assessments are performed and the patient is randomized 1:1 to receive 24 μg (metered dose) inhaled Interferon beta-1a or placebo once daily for 14 days (delivered by the I-neb® device [Philips Respironics]). Treatment should start as soon as possible but no later than 48 hours after the onset of the first of the common cold or flu symptoms. Patients will be assessed with regards to exacerbations and changes in respiratory symptoms and reliever medication use at home using an ePRO device. Lung function will be measured both at home by the patients and at the study site. There will be five clinical visits during the Treatment Phase and two visits after the end of treatment; efficacy and safety will be monitored until 2-3 weeks after end of treatment when a final follow-up visit will take place.
The study population will comprise adult asthmatic patients on a maintenance treatment of medium to high dose inhaled corticosteroids and a second controller medication (eg, long- acting β2 agonist), with a documented history of at least two severe exacerbations within the last 24 months, of which at least one has occurred during the last 12 months, and it is suspected by the patient that these aforementioned exacerbations were triggered by an upper respiratory tract infection (ie, related to symptoms of a common cold or the flu).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo (matching) | Placebo Comparator | Placebo, once daily inhalation for 14 days |
|
| Interferon beta-1a | Experimental | Interferon beta-1a, 24 μg (metered dose) once daily inhalation for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon beta-1a Nebuliser solution 48 μg/mL | Drug | Interferon beta-1a, 0,5 ml (24 μg, metered dose) once daily inhalation for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With a Severe Asthma Exacerbation During 14 Days of Treatment | Evaluation of the efficacy of inhaled AZD9412 compared to placebo in preventing severe exacerbations during the 14 day treatment phase following the onset of an URTI in asthmatic patients. A severe exacerbation was defined as worsening asthma symptoms and
The number of patients with severe asthma exacerbations with onset during the treatment phase is presented for each treatment group. | Day 1 - 14 of the treatment phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With Severe Asthma Exacerbations Within 7 and 30 Days Following Randomisation | Evaluation of the efficacy of inhaled AZD9412 compared to placebo in preventing severe exacerbations within 7 and 30 days after the start of treatment (Day 1). A severe exacerbation was defined as worsening asthma symptoms and
The numbers of patients with severe asthma exacerbations with onset during Days 1 - 7 and Days 1 - 30 are presented for each treatment group. |
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Inclusion Criteria:
For inclusion in the study patients should fulfil the following criteria:
Exclusion Criteria:
Patients should not enter the study if any of the following exclusion criteria are fulfilled:
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)
Previous randomization to treatment in the present study
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
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
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
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
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
Abnormal vital signs, after at least 10 minutes supine rest, defined as any of the following:
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
Prolonged QTcF >450 ms (for both gender) or shortened QTcF <340 ms or family history of long QT syndrome
PR(PQ) interval shortening <120ms (PR<120 ms but >110 ms is acceptable if there is no evidence of ventricular pre-excitation).
PR(PQ) interval prolongation (>240ms), intermittent second or third degree AV block, or AV dissociation
QRS duration >120ms including persistent or intermittent bundle branch block
Patients with implantable cardiac defibrillator (ICD) or a permanent pacemaker and patients with symptomatic ventricular and / or atrial tachyarrhythmias
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
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
History of hypersensitivity to natural or recombinant Interferon beta-1a or to any of the drug preparation excipients
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
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
History of epilepsy or seizures after the age of 5 years, other than febrile childhood seizure(s)
History of drug or alcohol abuse within 12 months prior to enrolment
Patients who have hepatic serum enzyme levels ≥2.5 times the normal range
Positive test for serum hepatitis B surface antigen, hepatitis C antibody, or HIV
Patients with a smoking history of ≥20 pack-years (1 pack year = 20 cigarettes smoked per day for one year)
Female who is breast-feeding, pregnant (verified by urine dipstick pregnancy test) or intends to become pregnant during the study
Patients who are unable to demonstrate an acceptable spirometry technique
Patients that have previously been included in studies evaluating the investigational medicinal product
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| Name | Affiliation | Role |
|---|---|---|
| Per Gustafson, MD PhD | AstraZeneca, R&D mölndal | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Buenos Aires | C1414AIF | Argentina | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33091192 | Derived | McCrae C, Olsson M, Gustafson P, Malmgren A, Aurell M, Fageras M, Da Silva CA, Cavallin A, Paraskos J, Karlsson K, Wingren C, Monk P, Marsden R, Harrison T. INEXAS: A Phase 2 Randomized Trial of On-demand Inhaled Interferon Beta-1a in Severe Asthmatics. Clin Exp Allergy. 2021 Feb;51(2):273-283. doi: 10.1111/cea.13765. Epub 2020 Nov 3. |
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349 patients enrolled (signed informed consent) and 228 were not randomised. 121 patients met randomisation criteria and entered the pre-treatment phase. Patients were treated after developing symptoms of an upper respiratory tract infection (URTI) if they met all the inclusion criteria and none of the exclusion criteria for the treatment phase.
First patient enrolled: 21 July 2015; Last Patient Last Visit: 24 November 2016. The study was performed at 39 sites in 7 countries including Argentina, Australia, Colombia, France, South Korea, Spain and the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | AZD9412 | Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI. Patients randomised to the AZD9412 group received 6 Million International Units (MIU) (24 micrograms [mcg] metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device. Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an electronic Patient Reported Outcome (ePRO) device at home. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Pre-treatment Phase |
|
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| Placebo | Drug | Placebo solution for once daily inhalation for 14 days |
|
| Day 1 of treatment phase up to 30 days post-randomisation. |
| Proportion of Patients With Moderate Asthma Exacerbation Within 7, 14 and 30 Days Following Randomisation | Evaluation of the efficacy of inhaled AZD9412 compared to placebo in preventing moderate exacerbations within 7, 14 and 30 days after the start of treatment (Day 1). A moderate exacerbation was defined as a temporary increase in maintenance therapy in order to prevent a severe event supported by a sustained (2 or more days) worsening in at least one key control metric, including asthma score, rescue use, night time awakening or morning peak expiratory flow. The numbers of patients with moderate exacerbations with onset during Days 1 - 7, Days 1 - 14 and Days 1 - 30 are presented for each treatment group. With respect to the Day 1-7 analysis, the model did not converge so the analysis could not be performed. | Day 1 of treatment phase up to 30 days post-randomisation. |
| Time to First Severe Asthma Exacerbation During 30 Days Following Randomisation | The time to first event was calculated as start date of events - date of randomisation + 1. Patients with no observed event were censored at the date of their last visit, or for lost-to-follow-up patients, at the last time point after which an event could not be assessed. The median time to first exacerbation was not calculated in either treatment group due to low numbers of events. | From Day 1 of treatment phase up to 30 days post-randomisation. |
| Time to First Moderate Asthma Exacerbation During 30 Days Following Randomisation | The time to first event was calculated as start date of events - date of randomisation + 1. Patients with no observed event were censored at the date of their last visit, or for lost-to-follow-up patients, at the last time point after which an event could not be assessed. The median time to first exacerbation was not calculated in either treatment group due to low numbers of events. | From Day 1 of treatment phase up to 30 days post-randomisation. |
| Duration of Moderate or Severe Exacerbations | The duration of each individual moderate or severe exacerbation was calculated as: Cessation date of exacerbation - Start date of exacerbation + 1. The start date of a severe exacerbation was defined as the start date of systemic corticosteroids or increase of systemic corticosteroids or emergency room visit or hospital admission, whichever occurred first. The stop date was defined as the last day of systemic corticosteroids/increase of systemic corticosteroids or hospital discharge, whichever occurred last. The start date of a moderate exacerbation was defined as the first day of increase in temporary maintenance therapy. The stop date was defined as the last day of this treatment. The mean duration of moderate or severe exacerbations is presented for each treatment group. | Day 1 of treatment phase up to 30 days post-randomisation. |
| Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) | The ACQ-6 consists of 6 questions to assess asthma control, each question measured on a 7-point scale scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 total score is computed as the un-weighted mean of the responses to the 6 questions. Baseline assessments were taken as the last non-missing assessment prior to randomisation. The change from baseline at Visit 4 (Day 7 +/- 1), at Visit 6 (Day 14 +/- 1) and at Visit 8 (Day 30) is presented for the total score and for each of the 6 questions. | From baseline up to 30 days after start of treatment phase. |
| AUC for Change in Daytime and Night-time Asthma Symptom Score From Baseline up to 30 Days | Asthma symptoms during night-time and daytime were recorded by the patient each morning and evening in the Asthma Daily Diary on a daily basis. Symptoms were recorded using a scale of 0 to 3 where 0 indicates no asthma symptoms up to an absolute score of 3. Baseline assessments were taken as the last non-missing assessment prior to randomisation. The total daily asthma symptom score was calculated by taking the sum of the night-time and daytime asthma scores recorded each day. The outcome variable is the area under the curve (AUC) for change from baseline in day-time, night-time and total daily asthma symptom scores over Days 1-14, Days 1-7, Days 8-14 and Days 15-30. | From baseline up to 30 days after start of treatment phase. |
| Change in the Proportion of Night-time Awakening Using the ePRO Questionnaire From Baseline up to 30 Days | Night-time awakenings due to asthma symptoms were recorded by the patient in the Asthma Daily Diary each morning by answering the question whether he/she woke up during the night due to asthma symptoms with a 'yes' or 'no' response. Biweekly means were calculated as the percentages of times the subject answered 'yes' over a period of 14 sequential days. Biweekly means are presented for the periods over Days 2-15 and Days 16-30. | From baseline up to 30 days after start of treatment phase. |
| Change in Health-related Quality of Life as Measured by the Asthma Quality of Life Questionnaire (AQLQ[S]) From Baseline up to 30 Days | The AQLQ(S) was used to assess health-related quality of life and consisted of 32 questions. Patients were asked to score each of the questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The questions were allocated to 4 domains assessing:
The overall score was calculated as the mean of the responses to all questions. The mean change in overall score from baseline at Visit 6 (Day 14+/-1) and Visit 8 (Day 30) are presented. | From baseline up to 30 days after start of treatment phase. |
| AUC for Change in Daytime and Night-time Reliever Medication Use From Baseline up to 14 Days | Patients recorded the number of reliever medication inhalations taken twice daily in the Asthma Daily Diary. The number of inhalations taken between the morning and evening lung function assessments were recorded in the evening. The number of inhalations taken between the evening and morning lung function assessments were recorded in the morning. Baseline assessments were taken as the last non-missing assessment prior to randomisation. The AUC for change from baseline over Days 1-14 (inclusive of Days 1 and 14) is presented. | From baseline up to Day 14 of treatment phase. |
| AUC for Change in the Morning Peak Expiratory Flow (PEF) From Baseline to up to 30 Days | Patients measured morning PEF at home and recorded the results using the ePRO device. Baseline assessments were taken as the last non-missing assessment prior to randomisation. The mean AUC for change from baseline is presented for the periods Days 1-14, 1-7, 8-14 and 15-30. | From baseline up to 30 days after start of treatment phase. |
| AUC for Change in the Morning Forced Expiratory Volume in 1 Second (FEV1) From Baseline up to 30 Days | Patients measured morning FEV1 at home and recorded the results using the ePRO device. Baseline assessments were taken as the last non-missing assessment prior to randomisation. The mean AUC for change from baseline is presented for the periods Days 1-14, 1-7, 8-14 and 15-30. | From baseline up to 30 days after start of treatment phase. |
| AUC for Change in the Evening PEF From Baseline to up to 30 Days | Patients measured evening PEF at home and recorded the results using the ePRO device. Baseline assessments were taken as the last non-missing assessment prior to randomisation. The mean AUC for change from baseline is presented for the periods Days 1-14, 1-7, 8-14 and 15-30. | From baseline up to 30 days after start of treatment phase. |
| AUC for Change in the Evening FEV1 From Baseline up to 30 Days | Patients measured evening FEV1 at home and recorded the results using the ePRO device. Baseline assessments were taken as the last non-missing assessment prior to randomisation. The mean AUC for change from baseline is presented for the periods Days 1-14, 1-7, 8-14 and 15-30. | From baseline up to 30 days after start of treatment phase. |
| CABA |
| C1425BEN |
| Argentina |
| Research Site | Ciudad Autonomade Buenos Aires | 1426 | Argentina |
| Research Site | Nueve de Julio | B6500EZL | Argentina |
| Research Site | Quilmes | B1878FNR | Argentina |
| Research Site | Bedford Park | 5042 | Australia |
| Research Site | New Lambton | 2310 | Australia |
| Research Site | Westmead | 2145 | Australia |
| Research Site | Woolloongabba | 4102 | Australia |
| Research Site | Bogotá | 110311 | Colombia |
| Research Site | Bogotá | Colombia |
| Research Site | Floridablanca | 680006 | Colombia |
| Research Site | Dijon | 21079 | France |
| Research Site | Lyon | 69317 | France |
| Research Site | Marseille | 13015 | France |
| Research Site | Montpellier | 34295 | France |
| Research Site | Paris | 75877 | France |
| Research Site | Pessac | 33604 | France |
| Research Site | Bucheon-si | 14584 | South Korea |
| Research Site | Jeonju | 54907 | South Korea |
| Research Site | Seoul | 02559 | South Korea |
| Research Site | Seoul | 03080 | South Korea |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Barcelona | 08003 | Spain |
| Research Site | Marbella (Málaga) | 29603 | Spain |
| Research Site | Málaga | 29010 | Spain |
| Research Site | Seville | 41071 | Spain |
| Research Site | Valencia | 46017 | Spain |
| Research Site | Blackpool | FY4 3AD | United Kingdom |
| Research Site | Bradford | BD9 6RJ | United Kingdom |
| Research Site | Lancaster | LA1 4RP | United Kingdom |
| Research Site | Leeds | LS9 7TF | United Kingdom |
| Research Site | Manchester | M23 9QZ | United Kingdom |
| Research Site | Nottingham | NG5 1PB | United Kingdom |
| Research Site | Southampton | SO9 4XY | United Kingdom |
| FG001 | Placebo | Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI. Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device. Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home. |
| COMPLETED |
|
| NOT COMPLETED |
|
| Treatment Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AZD9412 | Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI. Patients randomised to the AZD9412 group received 6 MIU (24 mcg metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device. Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home. |
| BG001 | Placebo | Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI. Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device. Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Proportion of Patients With a Severe Asthma Exacerbation During 14 Days of Treatment | Evaluation of the efficacy of inhaled AZD9412 compared to placebo in preventing severe exacerbations during the 14 day treatment phase following the onset of an URTI in asthmatic patients. A severe exacerbation was defined as worsening asthma symptoms and
The number of patients with severe asthma exacerbations with onset during the treatment phase is presented for each treatment group. | The Intention to treat (ITT) analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available. | Posted | Count of Participants | Participants | Day 1 - 14 of the treatment phase. |
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| Secondary | Proportion of Patients With Severe Asthma Exacerbations Within 7 and 30 Days Following Randomisation | Evaluation of the efficacy of inhaled AZD9412 compared to placebo in preventing severe exacerbations within 7 and 30 days after the start of treatment (Day 1). A severe exacerbation was defined as worsening asthma symptoms and
The numbers of patients with severe asthma exacerbations with onset during Days 1 - 7 and Days 1 - 30 are presented for each treatment group. | The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available. | Posted | Count of Participants | Participants | Day 1 of treatment phase up to 30 days post-randomisation. |
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| Secondary | Proportion of Patients With Moderate Asthma Exacerbation Within 7, 14 and 30 Days Following Randomisation | Evaluation of the efficacy of inhaled AZD9412 compared to placebo in preventing moderate exacerbations within 7, 14 and 30 days after the start of treatment (Day 1). A moderate exacerbation was defined as a temporary increase in maintenance therapy in order to prevent a severe event supported by a sustained (2 or more days) worsening in at least one key control metric, including asthma score, rescue use, night time awakening or morning peak expiratory flow. The numbers of patients with moderate exacerbations with onset during Days 1 - 7, Days 1 - 14 and Days 1 - 30 are presented for each treatment group. With respect to the Day 1-7 analysis, the model did not converge so the analysis could not be performed. | The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available. | Posted | Count of Participants | Participants | Day 1 of treatment phase up to 30 days post-randomisation. |
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| Secondary | Time to First Severe Asthma Exacerbation During 30 Days Following Randomisation | The time to first event was calculated as start date of events - date of randomisation + 1. Patients with no observed event were censored at the date of their last visit, or for lost-to-follow-up patients, at the last time point after which an event could not be assessed. The median time to first exacerbation was not calculated in either treatment group due to low numbers of events. | The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available. | Posted | Median | Full Range | Days | From Day 1 of treatment phase up to 30 days post-randomisation. |
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| Secondary | Time to First Moderate Asthma Exacerbation During 30 Days Following Randomisation | The time to first event was calculated as start date of events - date of randomisation + 1. Patients with no observed event were censored at the date of their last visit, or for lost-to-follow-up patients, at the last time point after which an event could not be assessed. The median time to first exacerbation was not calculated in either treatment group due to low numbers of events. | The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available. | Posted | Median | Full Range | Days | From Day 1 of treatment phase up to 30 days post-randomisation. |
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| Secondary | Duration of Moderate or Severe Exacerbations | The duration of each individual moderate or severe exacerbation was calculated as: Cessation date of exacerbation - Start date of exacerbation + 1. The start date of a severe exacerbation was defined as the start date of systemic corticosteroids or increase of systemic corticosteroids or emergency room visit or hospital admission, whichever occurred first. The stop date was defined as the last day of systemic corticosteroids/increase of systemic corticosteroids or hospital discharge, whichever occurred last. The start date of a moderate exacerbation was defined as the first day of increase in temporary maintenance therapy. The stop date was defined as the last day of this treatment. The mean duration of moderate or severe exacerbations is presented for each treatment group. | The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available. The number of patients in the analysis are those with at least 1 exacerbation. | Posted | Mean | Standard Deviation | Days | Day 1 of treatment phase up to 30 days post-randomisation. |
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| Secondary | Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) | The ACQ-6 consists of 6 questions to assess asthma control, each question measured on a 7-point scale scored from 0 (totally controlled) to 6 (severely uncontrolled). The ACQ-6 total score is computed as the un-weighted mean of the responses to the 6 questions. Baseline assessments were taken as the last non-missing assessment prior to randomisation. The change from baseline at Visit 4 (Day 7 +/- 1), at Visit 6 (Day 14 +/- 1) and at Visit 8 (Day 30) is presented for the total score and for each of the 6 questions. | The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available. Patients with non-missing values were included in the analysis. | Posted | Least Squares Mean | Standard Error | Units on a Scale | From baseline up to 30 days after start of treatment phase. |
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| Secondary | AUC for Change in Daytime and Night-time Asthma Symptom Score From Baseline up to 30 Days | Asthma symptoms during night-time and daytime were recorded by the patient each morning and evening in the Asthma Daily Diary on a daily basis. Symptoms were recorded using a scale of 0 to 3 where 0 indicates no asthma symptoms up to an absolute score of 3. Baseline assessments were taken as the last non-missing assessment prior to randomisation. The total daily asthma symptom score was calculated by taking the sum of the night-time and daytime asthma scores recorded each day. The outcome variable is the area under the curve (AUC) for change from baseline in day-time, night-time and total daily asthma symptom scores over Days 1-14, Days 1-7, Days 8-14 and Days 15-30. | The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available. Patients with non-missing values were included in the analysis. | Posted | Least Squares Mean | Standard Error | Units on Scale | From baseline up to 30 days after start of treatment phase. |
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| Secondary | Change in the Proportion of Night-time Awakening Using the ePRO Questionnaire From Baseline up to 30 Days | Night-time awakenings due to asthma symptoms were recorded by the patient in the Asthma Daily Diary each morning by answering the question whether he/she woke up during the night due to asthma symptoms with a 'yes' or 'no' response. Biweekly means were calculated as the percentages of times the subject answered 'yes' over a period of 14 sequential days. Biweekly means are presented for the periods over Days 2-15 and Days 16-30. | The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available. Patients with non-missing values were included in the analysis. | Posted | Mean | Standard Deviation | Percentage of 'yes' responses | From baseline up to 30 days after start of treatment phase. |
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| Secondary | Change in Health-related Quality of Life as Measured by the Asthma Quality of Life Questionnaire (AQLQ[S]) From Baseline up to 30 Days | The AQLQ(S) was used to assess health-related quality of life and consisted of 32 questions. Patients were asked to score each of the questions on a 7-point scale ranging from 7 (no impairment) to 1 (severe impairment). The questions were allocated to 4 domains assessing:
The overall score was calculated as the mean of the responses to all questions. The mean change in overall score from baseline at Visit 6 (Day 14+/-1) and Visit 8 (Day 30) are presented. | The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available. Patients with non-missing values were included in the analysis. | Posted | Least Squares Mean | Standard Error | Units on Scale | From baseline up to 30 days after start of treatment phase. |
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| Secondary | AUC for Change in Daytime and Night-time Reliever Medication Use From Baseline up to 14 Days | Patients recorded the number of reliever medication inhalations taken twice daily in the Asthma Daily Diary. The number of inhalations taken between the morning and evening lung function assessments were recorded in the evening. The number of inhalations taken between the evening and morning lung function assessments were recorded in the morning. Baseline assessments were taken as the last non-missing assessment prior to randomisation. The AUC for change from baseline over Days 1-14 (inclusive of Days 1 and 14) is presented. | The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available. Patients with non-missing values were included in the analysis. | Posted | Least Squares Mean | Standard Error | Inhalations | From baseline up to Day 14 of treatment phase. |
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| Secondary | AUC for Change in the Morning Peak Expiratory Flow (PEF) From Baseline to up to 30 Days | Patients measured morning PEF at home and recorded the results using the ePRO device. Baseline assessments were taken as the last non-missing assessment prior to randomisation. The mean AUC for change from baseline is presented for the periods Days 1-14, 1-7, 8-14 and 15-30. | The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available. Patients with non-missing values were included in the analysis. | Posted | Least Squares Mean | Standard Error | litres/minute (l/min) | From baseline up to 30 days after start of treatment phase. |
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| Secondary | AUC for Change in the Morning Forced Expiratory Volume in 1 Second (FEV1) From Baseline up to 30 Days | Patients measured morning FEV1 at home and recorded the results using the ePRO device. Baseline assessments were taken as the last non-missing assessment prior to randomisation. The mean AUC for change from baseline is presented for the periods Days 1-14, 1-7, 8-14 and 15-30. | The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available. Patients with non-missing values were included in the analysis. | Posted | Least Squares Mean | Standard Error | litres | From baseline up to 30 days after start of treatment phase. |
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| Secondary | AUC for Change in the Evening PEF From Baseline to up to 30 Days | Patients measured evening PEF at home and recorded the results using the ePRO device. Baseline assessments were taken as the last non-missing assessment prior to randomisation. The mean AUC for change from baseline is presented for the periods Days 1-14, 1-7, 8-14 and 15-30. | The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available. Patients with non-missing values were included in the analysis. | Posted | Least Squares Mean | Standard Error | l/min | From baseline up to 30 days after start of treatment phase. |
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| Secondary | AUC for Change in the Evening FEV1 From Baseline up to 30 Days | Patients measured evening FEV1 at home and recorded the results using the ePRO device. Baseline assessments were taken as the last non-missing assessment prior to randomisation. The mean AUC for change from baseline is presented for the periods Days 1-14, 1-7, 8-14 and 15-30. | The ITT analysis set consisted of all randomised patients who received at least 1 dose of investigational product and had some post-dose data available. Patients with non-missing values were included in the analysis. | Posted | Least Squares Mean | Standard Error | litres | From baseline up to 30 days after start of treatment phase. |
|
Treatment emergent adverse events were collected from the first day of study treatment up to the last date of follow-up (approximately 30 days).
The safety analysis set consisted of all randomised patients who received at least 1 dose of investigational product and with post-dose data available.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD9412 | Patients were randomised to receive investigational product AZD9412 (interferon beta-1a) in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI. Patients randomised to the AZD9412 group received 6 Million International Units (MIU) (24 micrograms [mcg] metered dose) inhaled AZD9412 once daily for 14 days, delivered by the I-neb® device. Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an electronic Patient Reported Outcome (ePRO) device at home. | 3 | 61 | 27 | 61 | ||
| EG001 | Placebo | Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI. Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device. Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home. | 0 | 60 | 20 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosinophilia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Blepharospasm | Eye disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Injury associated with device | General disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Conjunctivitis bacterial | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Mouth injury | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA Version 19.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Glycosylated haemoglobin increased | Investigations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Pulmonary function test decreased | Investigations | MedDRA Version 19.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Emotional distress | Psychiatric disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Mood altered | Psychiatric disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Sinus pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA Version 19.1 | Systematic Assessment |
|
The study was terminated early due to the lower than expected rate of severe exacerbations in the study as a whole, and due to the observed lack of differential effect at interim analysis.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Science Director | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007239 | Infections |
Not provided
Not provided
| Investigator and Sponsor decision |
|
| Male |
|
| OG001 | Placebo | Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI. Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device. Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home. |
|
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| OG001 | Placebo | Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI. Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device. Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home. |
|
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|
Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI. Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device. Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home. |
|
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|
Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI. Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device. Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home. |
|
|
|
| OG001 | Placebo | Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI. Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device. Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home. |
|
|
| OG001 | Placebo | Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI. Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device. Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home. |
|
|
|
| OG001 | Placebo | Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI. Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device. Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home. |
|
|
|
| OG001 | Placebo | Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI. Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device. Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home. |
|
|
| OG001 | Placebo | Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI. Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device. Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home. |
|
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|
| OG001 | Placebo | Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI. Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device. Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home. |
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|
Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI. Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device. Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home. |
|
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|
Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI. Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device. Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home. |
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|
Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.
Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.
Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.
|
|
|
Patients were randomised to receive placebo in the treatment phase. Eligible patients entered the pre-treatment phase until they developed symptoms of a common cold or the flu (URTI). Patients were evaluated at a study site for eligibility to enter the treatment phase as soon as possible but no later than 48 hours after the onset of the first symptoms of an URTI.
Patients randomised to the placebo group received 6 MIU (24 mcg metered dose) inhaled placebo once daily for 14 days, delivered by the I-neb® device.
Patients continued their regular asthma maintenance treatment, and were assessed for exacerbations, changes in respiratory symptoms and reliever medication use using an ePRO device at home.
|
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