Trial Outcomes & Findings for 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 (NCT NCT02491684)

Last Updated: 2019-02-12

Results Overview

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 1. use of systemic corticosteroids (or a temporary increase of at least 2-fold in a stable oral corticosteroid background dose) for at least 3 consecutive days and/or 2. an unscheduled visit or emergency room visit due to asthma symptoms that required at least 1 dose of systemic corticosteroids and/or 3. an in-patient hospitalisation due to asthma requiring at least 1 dose of systemic corticosteroids. The number of patients with severe asthma exacerbations with onset during the treatment phase is presented for each treatment group.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

121 participants

Primary outcome timeframe

Day 1 - 14 of the treatment phase.

Results posted on

2019-02-12

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.
Pre-treatment Phase STARTED	61	60
Pre-treatment Phase COMPLETED	61	60
Pre-treatment Phase NOT COMPLETED	0	0
Treatment Phase STARTED	61	60
Treatment Phase COMPLETED	58	57
Treatment Phase NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Treatment Phase Adverse Event	2	2
Treatment Phase Incorrect randomisation	1	0
Treatment Phase Investigator and Sponsor decision	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AZD9412 n=61 Participants 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.	Placebo n=60 Participants 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.	Total n=121 Participants Total of all reporting groups
Age, Continuous	47.8 years STANDARD_DEVIATION 12.95 • n=5 Participants	47.7 years STANDARD_DEVIATION 14.10 • n=7 Participants	47.7 years STANDARD_DEVIATION 13.48 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	43 Participants n=7 Participants	91 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	17 Participants n=7 Participants	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 - 14 of the treatment phase.

Population: 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.

Outcome measures

Outcome measures
Measure	AZD9412 n=61 Participants 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.	Placebo n=60 Participants 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.
Proportion of Patients With a Severe Asthma Exacerbation During 14 Days of Treatment	7 Participants	5 Participants

SECONDARY outcome

Timeframe: Day 1 of treatment phase up to 30 days post-randomisation.

Population: 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.

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 1. use of systemic corticosteroids (or a temporary increase of at least 2-fold in a stable oral corticosteroid background dose) for at least 3 consecutive days and/or 2. an unscheduled visit or emergency room visit due to asthma symptoms that required at least 1 dose of systemic corticosteroids and/or 3. an in-patient hospitalisation due to asthma requiring at least 1 dose of systemic corticosteroids. The numbers of patients with severe asthma exacerbations with onset during Days 1 - 7 and Days 1 - 30 are presented for each treatment group.

Outcome measures

Outcome measures
Measure	AZD9412 n=61 Participants 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.	Placebo n=60 Participants 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.
Proportion of Patients With Severe Asthma Exacerbations Within 7 and 30 Days Following Randomisation Days 1 - 7	4 Participants	2 Participants
Proportion of Patients With Severe Asthma Exacerbations Within 7 and 30 Days Following Randomisation Days 1 - 30	8 Participants	6 Participants

SECONDARY outcome

Timeframe: Day 1 of treatment phase up to 30 days post-randomisation.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	AZD9412 n=61 Participants 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.	Placebo n=60 Participants 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.
Proportion of Patients With Moderate Asthma Exacerbation Within 7, 14 and 30 Days Following Randomisation Days 1 - 14	1 Participants	1 Participants
Proportion of Patients With Moderate Asthma Exacerbation Within 7, 14 and 30 Days Following Randomisation Days 1 - 7	0 Participants	1 Participants
Proportion of Patients With Moderate Asthma Exacerbation Within 7, 14 and 30 Days Following Randomisation Days 1 - 30	1 Participants	1 Participants

SECONDARY outcome

Timeframe: From Day 1 of treatment phase up to 30 days post-randomisation.

Population: 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 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.

Outcome measures

Outcome measures
Measure	AZD9412 n=61 Participants 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.	Placebo n=60 Participants 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.
Time to First Severe Asthma Exacerbation During 30 Days Following Randomisation	NA Days The median time to severe exacerbation was not calculated due to low numbers of events.	NA Days The median time to severe exacerbation was not calculated due to low numbers of events.

SECONDARY outcome

Timeframe: From Day 1 of treatment phase up to 30 days post-randomisation.

Population: 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.

Outcome measures

Outcome measures
Measure	AZD9412 n=61 Participants 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.	Placebo n=60 Participants 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.
Time to First Moderate Asthma Exacerbation During 30 Days Following Randomisation	NA Days The median time to moderate exacerbation was not calculated due to low numbers of events.	NA Days The median time to moderate exacerbation was not calculated due to low numbers of events.

SECONDARY outcome

Timeframe: Day 1 of treatment phase up to 30 days post-randomisation.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	AZD9412 n=8 Participants 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.	Placebo n=6 Participants 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.
Duration of Moderate or Severe Exacerbations	10 Days Standard Deviation 7.7	8 Days Standard Deviation 4.5

SECONDARY outcome

Timeframe: From baseline up to 30 days after start of treatment phase.

Population: 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.

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.

Outcome measures

Outcome measures
Measure	AZD9412 n=61 Participants 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.	Placebo n=60 Participants 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.
Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) ACQ-6 Total Score, Visit 6	-0.15 Units on a Scale Standard Error 0.14	-0.21 Units on a Scale Standard Error 0.14
Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) Q2: Symptoms at Awakening, Visit 4	0.06 Units on a Scale Standard Error 0.18	-0.17 Units on a Scale Standard Error 0.18
Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) Q2: Symptoms at Awakening, Visit 6	-0.40 Units on a Scale Standard Error 0.16	-0.33 Units on a Scale Standard Error 0.17
Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) Q3: Limited in Activities, Visit 6	-0.12 Units on a Scale Standard Error 0.17	0.16 Units on a Scale Standard Error 0.18
Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) Q4: Shortness of Breath, Visit 6	-0.34 Units on a Scale Standard Error 0.19	-0.38 Units on a Scale Standard Error 0.21
Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) Q5: Wheeze, Visit 4	0.13 Units on a Scale Standard Error 0.17	0.08 Units on a Scale Standard Error 0.17
Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) Q5: Wheeze, Visit 8	-0.33 Units on a Scale Standard Error 0.21	-0.42 Units on a Scale Standard Error 0.21
Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) Q6: Puffs of Short-Acting Bronchodilator; Visit 4	0.06 Units on a Scale Standard Error 0.13	0.00 Units on a Scale Standard Error 0.14
Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) Q6: Puffs of Short-Acting Bronchodilator; Visit 8	0.04 Units on a Scale Standard Error 0.14	-0.03 Units on a Scale Standard Error 0.14
Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) ACQ-6 Total Score, Visit 4	0.02 Units on a Scale Standard Error 0.11	-0.07 Units on a Scale Standard Error 0.12
Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) ACQ-6 Total Score, Visit 8	-0.42 Units on a Scale Standard Error 0.15	-0.35 Units on a Scale Standard Error 0.15
Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) Q1: Woken by Asthma, Visit 4	0.09 Units on a Scale Standard Error 0.18	-0.09 Units on a Scale Standard Error 0.18
Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) Q1: Woken by Asthma, Visit 6	0.15 Units on a Scale Standard Error 0.20	-0.28 Units on a Scale Standard Error 0.21
Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) Q1: Woken by Asthma, Visit 8	-0.50 Units on a Scale Standard Error 0.18	-0.32 Units on a Scale Standard Error 0.18
Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) Q2: Symptoms at Awakening, Visit 8	-0.76 Units on a Scale Standard Error 0.19	-0.47 Units on a Scale Standard Error 0.19
Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) Q3: Limited in Activities, Visit 4	0.04 Units on a Scale Standard Error 0.15	0.06 Units on a Scale Standard Error 0.15
Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) Q3: Limited in Activities, Visit 8	-0.43 Units on a Scale Standard Error 0.18	-0.33 Units on a Scale Standard Error 0.18
Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) Q4: Shortness of Breath, Visit 4	-0.13 Units on a Scale Standard Error 0.15	-0.11 Units on a Scale Standard Error 0.16
Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) Q4: Shortness of Breath, Visit 8	-0.46 Units on a Scale Standard Error 0.18	-0.37 Units on a Scale Standard Error 0.19
Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) Q5: Wheeze, Visit 6	-0.17 Units on a Scale Standard Error 0.17	-0.17 Units on a Scale Standard Error 0.18
Change in Asthma Control From Baseline up to 30 Days as Measured by the Asthma Control Questionnaire (ACQ-6) Q6: Puffs of Short-Acting Bronchodilator; Visit 6	0.07 Units on a Scale Standard Error 0.14	-0.11 Units on a Scale Standard Error 0.15

SECONDARY outcome

Timeframe: From baseline up to 30 days after start of treatment phase.

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.

Outcome measures

Outcome measures
Measure	AZD9412 n=61 Participants 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.	Placebo n=60 Participants 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.
AUC for Change in Daytime and Night-time Asthma Symptom Score From Baseline up to 30 Days Daytime asthma score, Days 8-14	-0.23 Units on Scale Standard Error 0.07	-0.27 Units on Scale Standard Error 0.07
AUC for Change in Daytime and Night-time Asthma Symptom Score From Baseline up to 30 Days Night-time asthma score, Days 1-14	-0.17 Units on Scale Standard Error 0.07	-0.16 Units on Scale Standard Error 0.08
AUC for Change in Daytime and Night-time Asthma Symptom Score From Baseline up to 30 Days Night-time asthma score, Days 15-30	-0.44 Units on Scale Standard Error 0.09	-0.39 Units on Scale Standard Error 0.09
AUC for Change in Daytime and Night-time Asthma Symptom Score From Baseline up to 30 Days Total asthma score, Days 1-14	-0.20 Units on Scale Standard Error 0.16	-0.31 Units on Scale Standard Error 0.16
AUC for Change in Daytime and Night-time Asthma Symptom Score From Baseline up to 30 Days Total asthma score, Days 1-7	-0.11 Units on Scale Standard Error 0.13	-0.22 Units on Scale Standard Error 0.13
AUC for Change in Daytime and Night-time Asthma Symptom Score From Baseline up to 30 Days Total asthma score, Days 8-14	-0.40 Units on Scale Standard Error 0.15	-0.41 Units on Scale Standard Error 0.16
AUC for Change in Daytime and Night-time Asthma Symptom Score From Baseline up to 30 Days Total asthma score, Days 15-30	-0.77 Units on Scale Standard Error 0.16	-0.77 Units on Scale Standard Error 0.16
AUC for Change in Daytime and Night-time Asthma Symptom Score From Baseline up to 30 Days Daytime asthma score, Days 1-14	-0.22 Units on Scale Standard Error 0.07	-0.26 Units on Scale Standard Error 0.07
AUC for Change in Daytime and Night-time Asthma Symptom Score From Baseline up to 30 Days Daytime asthma score, Days 1-7	-0.17 Units on Scale Standard Error 0.06	-0.17 Units on Scale Standard Error 0.06
AUC for Change in Daytime and Night-time Asthma Symptom Score From Baseline up to 30 Days Daytime asthma score, Days 15-30	-0.44 Units on Scale Standard Error 0.07	-0.41 Units on Scale Standard Error 0.07
AUC for Change in Daytime and Night-time Asthma Symptom Score From Baseline up to 30 Days Night-time asthma score, Days 1-7	-0.10 Units on Scale Standard Error 0.06	-0.09 Units on Scale Standard Error 0.07
AUC for Change in Daytime and Night-time Asthma Symptom Score From Baseline up to 30 Days Night-time asthma score, Days 8-14	-0.20 Units on Scale Standard Error 0.07	-0.17 Units on Scale Standard Error 0.08

SECONDARY outcome

Timeframe: From baseline up to 30 days after start of treatment phase.

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.

Outcome measures

Outcome measures
Measure	AZD9412 n=61 Participants 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.	Placebo n=60 Participants 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.
Change in the Proportion of Night-time Awakening Using the ePRO Questionnaire From Baseline up to 30 Days Days 2-15	22.3 Percentage of 'yes' responses Standard Deviation 30.42	24.8 Percentage of 'yes' responses Standard Deviation 29.77
Change in the Proportion of Night-time Awakening Using the ePRO Questionnaire From Baseline up to 30 Days Days 16-30	15.2 Percentage of 'yes' responses Standard Deviation 26.79	15.9 Percentage of 'yes' responses Standard Deviation 26.34

SECONDARY outcome

Timeframe: From baseline up to 30 days after start of treatment phase.

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: 1. activity limitation, 2. symptoms, 3. emotional function, and 4. environmental stimuli 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.

Outcome measures

Outcome measures
Measure	AZD9412 n=61 Participants 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.	Placebo n=60 Participants 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.
Change in Health-related Quality of Life as Measured by the Asthma Quality of Life Questionnaire (AQLQ[S]) From Baseline up to 30 Days Overall Score Visit 6	0.28 Units on Scale Standard Error 0.13	0.35 Units on Scale Standard Error 0.14
Change in Health-related Quality of Life as Measured by the Asthma Quality of Life Questionnaire (AQLQ[S]) From Baseline up to 30 Days Overall Score Visit 8	0.43 Units on Scale Standard Error 0.16	0.53 Units on Scale Standard Error 0.16

SECONDARY outcome

Timeframe: From baseline up to Day 14 of treatment phase.

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.

Outcome measures

Outcome measures
Measure	AZD9412 n=52 Participants 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.	Placebo n=48 Participants 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.
AUC for Change in Daytime and Night-time Reliever Medication Use From Baseline up to 14 Days	-0.12 Inhalations Standard Error 0.46	-0.67 Inhalations Standard Error 0.48

SECONDARY outcome

Timeframe: From baseline up to 30 days after start of treatment phase.

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.

Outcome measures

Outcome measures
Measure	AZD9412 n=61 Participants 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.	Placebo n=60 Participants 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.
AUC for Change in the Morning Peak Expiratory Flow (PEF) From Baseline to up to 30 Days Days 1-14	9.56 litres/minute (l/min) Standard Error 14.02	-7.42 litres/minute (l/min) Standard Error 13.91
AUC for Change in the Morning Peak Expiratory Flow (PEF) From Baseline to up to 30 Days Days 1-7	19.66 litres/minute (l/min) Standard Error 9.66	0.31 litres/minute (l/min) Standard Error 9.11
AUC for Change in the Morning Peak Expiratory Flow (PEF) From Baseline to up to 30 Days Days 8-14	7.03 litres/minute (l/min) Standard Error 15.90	-7.35 litres/minute (l/min) Standard Error 15.80
AUC for Change in the Morning Peak Expiratory Flow (PEF) From Baseline to up to 30 Days Days 15-30	32.75 litres/minute (l/min) Standard Error 15.35	13.49 litres/minute (l/min) Standard Error 14.82

SECONDARY outcome

Timeframe: From baseline up to 30 days after start of treatment phase.

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.

Outcome measures

Outcome measures
Measure	AZD9412 n=61 Participants 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.	Placebo n=60 Participants 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.
AUC for Change in the Morning Forced Expiratory Volume in 1 Second (FEV1) From Baseline up to 30 Days Days 1-14	-0.00 litres Standard Error 0.08	-0.08 litres Standard Error 0.08
AUC for Change in the Morning Forced Expiratory Volume in 1 Second (FEV1) From Baseline up to 30 Days Days 1-7	0.10 litres Standard Error 0.06	0.02 litres Standard Error 0.06
AUC for Change in the Morning Forced Expiratory Volume in 1 Second (FEV1) From Baseline up to 30 Days Days 8-14	-0.03 litres Standard Error 0.08	-0.09 litres Standard Error 0.08
AUC for Change in the Morning Forced Expiratory Volume in 1 Second (FEV1) From Baseline up to 30 Days Days 15-30	0.15 litres Standard Error 0.09	0.04 litres Standard Error 0.08

SECONDARY outcome

Timeframe: From baseline up to 30 days after start of treatment phase.

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.

Outcome measures

Outcome measures
Measure	AZD9412 n=61 Participants 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.	Placebo n=60 Participants 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.
AUC for Change in the Evening PEF From Baseline to up to 30 Days Days 1-14	10.96 l/min Standard Error 12.58	-0.73 l/min Standard Error 11.88
AUC for Change in the Evening PEF From Baseline to up to 30 Days Days 1-7	8.78 l/min Standard Error 9.87	-2.41 l/min Standard Error 9.30
AUC for Change in the Evening PEF From Baseline to up to 30 Days Days 8-14	8.49 l/min Standard Error 13.09	-2.66 l/min Standard Error 12.55
AUC for Change in the Evening PEF From Baseline to up to 30 Days Days 15-30	11.88 l/min Standard Error 15.70	-5.25 l/min Standard Error 15.13

SECONDARY outcome

Timeframe: From baseline up to 30 days after start of treatment phase.

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.

Outcome measures

Outcome measures
Measure	AZD9412 n=61 Participants 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.	Placebo n=60 Participants 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.
AUC for Change in the Evening FEV1 From Baseline up to 30 Days Days 1-14	-0.01 litres Standard Error 0.07	-0.07 litres Standard Error 0.07
AUC for Change in the Evening FEV1 From Baseline up to 30 Days Days 1-7	0.01 litres Standard Error 0.07	-0.03 litres Standard Error 0.07
AUC for Change in the Evening FEV1 From Baseline up to 30 Days Days 8-14	-0.02 litres Standard Error 0.07	-0.08 litres Standard Error 0.07
AUC for Change in the Evening FEV1 From Baseline up to 30 Days Days 15-30	0.02 litres Standard Error 0.08	-0.08 litres Standard Error 0.08

Adverse Events

AZD9412

Serious events: 3 serious events

Other events: 27 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AZD9412 n=61 participants at risk 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.	Placebo n=60 participants at risk 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.
Respiratory, thoracic and mediastinal disorders Asthma	4.9% 3/61 • Number of events 4 • 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.	0.00% 0/60 • 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.

Other adverse events

Additional Information

Medical Science Director

AstraZeneca

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER