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Interferon beta-1a Nebuliser 48 μg/mL

Phase 2

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Trials Updated: Feb 12, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment121

FDA Designations

No designations recorded

Interferon beta-1a Nebuliser 48 μg/mL clinical trials

Interferon beta-1a Nebuliser 48 μg/mL · 1 trial · 1 indication

Phase 2 1
NCT02491684A 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 InfectionAsthma
COMPLETED121 Analytics
PHASE2COMPLETED
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
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of Patients With a Severe Asthma Exacerbation During 14 Days of Treatment
Day 1 - 14 of the treatment phase.

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.

Secondary Endpoints

Proportion of Patients With Severe Asthma Exacerbations Within 7 and 30 Days Following Randomisation
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
Day 1 of treatment phase up to 30 days post-randomisation.
Time to First Severe Asthma Exacerbation During 30 Days Following Randomisation
From Day 1 of treatment phase up to 30 days post-randomisation.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Placebo (matching)PLACEBO_COMPARATORPlacebo, once daily inhalation for 14 days
Interferon beta-1aEXPERIMENTALInterferon beta-1a, 24 μg (metered dose) once daily inhalation for 14 days

Interventions

NameTypeDescription
Interferon beta-1a Nebuliser solution 48 μg/mLDRUGInterferon beta-1a, 0,5 ml (24 μg, metered dose) once daily inhalation for 14 days
PlaceboDRUGPlacebo solution for once daily inhalation for 14 days
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Eligibility Criteria

Age Range18 Years to 99 Years
SexALL
Healthy VolunteersNo
Study Sites35

Inclusion Criteria: For inclusion in the study patients should fulfil the following criteria: 1. Provision of signed and dated written informed consent prior to any study specific procedures 2. Male or female aged 18 and above at the time of enrolment 3. History of physician-diagnosed asthma requi...

Countries:ArgentinaAustraliaColombiaFranceSouth KoreaSpainUnited Kingdom
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Frequently asked questions about Interferon beta-1a Nebuliser 48 μg/mL

What is Interferon beta-1a Nebuliser 48 μg/mL used for?

Interferon beta-1a Nebuliser 48 μg/mL is an inhaled formulation being developed for the treatment of asthma. It is given once daily by nebuliser and was studied in adults with asthma after the onset of symptoms of an upper respiratory tract infection.

Who is developing Interferon beta-1a Nebuliser 48 μg/mL?

Interferon beta-1a Nebuliser 48 μg/mL is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating this inhaled interferon beta-1a formulation in asthma.

What phase is Interferon beta-1a Nebuliser 48 μg/mL in?

Interferon beta-1a Nebuliser 48 μg/mL is in Phase 2 development. It is an investigational product and has not been approved for marketing. The Phase 2 study of this formulation has been completed.

What clinical trial has studied Interferon beta-1a Nebuliser 48 μg/mL?

Interferon beta-1a Nebuliser 48 μg/mL was studied in the Phase 2 trial NCT02491684, titled 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.

How was the Phase 2 trial of Interferon beta-1a Nebuliser 48 μg/mL designed?

The Phase 2 trial NCT02491684 enrolled 121 adults with asthma. It was randomized, double blind, and placebo controlled, with participants receiving 14 days of once daily inhaled treatment. The study ran in Argentina, Australia, Colombia, France, South Korea, Spain, and the United Kingdom.