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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03924635
Other study ID # D589BC00018
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 1, 2019
Est. completion date December 16, 2022

Study information

Verified date January 2023
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomised, active-comparator, open-label, parallel-group, multicentre phase IV exploratory study to characterise changes in airway inflammation, symptoms, lung function, and reliever use in asthma patients using SABA (salbutamol) or anti inflammatory reliever (SYMBICORT®) as reliever medication in addition to SYMBICORT as daily asthma controller. Eligible patients diagnosed with asthma at least 6 months prior to the Screening Visit (Visit 1) and fulfilling all of the inclusion criteria and none of the exclusion criteria will continue into the Run-in Period. At Visit 2, patients will be assessed for randomisation criteria and, if met, will be randomised to receive either SYMBICORT as maintenance and reliever treatment or SYMBICORT as maintenance treatment and salbutamol as reliever treatment in a 1:1 ratio. Randomisation will be stratified by the patient's ongoing dose of inhaled corticosteroids [(ICS) low or medium] or long-acting β2-agonist (ICS/LABA) at study entry


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
SYMBICORT and salbutamol
Salbutamol is a short-acting ß-agonist and SYMBICORT (fixed dose combination of inhaled corticosteroid plus long-acting ß2-agonist) is an anti-inflammatory reliever for asthma. SYMBICORT will be given in a TURBOHALER. Salbutamol will be given in a pressurised metered dose inhaler.

Locations

Country Name City State
United Kingdom Research Site Bradford
United Kingdom Research Site Dundee
United Kingdom Research Site Nottingham
United Kingdom Research Site Oxford
United Kingdom Research Site Watford
United Kingdom Research Site Wishaw

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Individual patient plots of fractional exhaled Nitric Oxide (FeNO) (morning) FeNO will be plotted over time for each patient. From Day 1 to Day 169 (Treatment period).
Primary Individual patient plots of asthma symptoms (morning and evening) Symptoms scores will be plotted over time for each patient. From Day 1 to Day 169 (Treatment period)
Primary Individual patient plots of occasions of reliever medication use (as needed) Reliever use will be plotted over time for each patient. From Day 1 to Day 169 (Treatment period)
Primary Individual patient plots of forced expiratory volume in 1 second (FEV1) (morning and evening) FEV1 will be plotted over time for each patient. From Day 1 to Day 169 (Treatment period)
Primary Individual patient plots of peak expiratory flow (PEF) (morning and evening) PEF will be plotted over time for each patient. From Day 1 to Day 169 (Treatment period)
Secondary Individual patient plots of FeNO (morning) FeNO will be plotted at the time of an event for each patient with an event. Events of interest are severe exacerbation, CompEx (full criteria), a single day (in 24 hours) with 6 or more occasions of reliever medication use, and FeNO >50 ppb. Day -14 to +28 of event (During treatment period only Day 1 to Day 169)
Secondary Individual patient plots of asthma symptoms (morning and evening) Symptoms scores will be plotted at the time of an event for each patient with an event. Events of interest are severe exacerbation, CompEx (full criteria), a single day (in 24 hours) with 6 or more occasions of reliever medication use, and FeNO >50 ppb. Day -14 to +28 of event (During treatment period only Day 1 to Day 169)
Secondary Individual patient plots of occasions of reliever medication use (as needed) Reliever use will be plotted at the time of an event for each patient with an event. Events of interest are severe exacerbation, CompEx (full criteria), a single day (in 24 hours) with 6 or more occasions of reliever medication use, and FeNO >50 ppb. Day -14 to +28 of event (During treatment period only Day 1 to Day 169)
Secondary Individual patient plots of FEV1 (morning and eveing) FEV1 will be plotted at the time of an event for each patient with an event. Events of interest are severe exacerbation, CompEx (full criteria), a single day (in 24 hours) with 6 or more occasions of reliever medication use, and FeNO >50 ppb. Day -14 to +28 of event (During treatment period only Day 1 to Day 169)
Secondary Individual patient plots of PEF (morning and evening) PEF will be plotted at the time of an event for each patient with an event. Events of interest are severe exacerbation, CompEx (full criteria), a single day (in 24 hours) with 6 or more occasions of reliever medication use, and FeNO >50 ppb. Day -14 to +28 of event (During treatment period only Day 1 to Day 169)
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