Airway InflammationPhase 4NCT03924635
An Exploratory Study to Characterise Changes in Airway Inflammation, Symptoms, Lung Function and Reliever Use in Adult Asthma Patients
A Phase 4 study testing SYMBICORT and salbutamol in people with Airway Inflammation and Asthma, run by AstraZeneca at 6 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Airway Inflammation, Asthma
- What is being tested?
- SYMBICORT and salbutamol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 1 Aug 2019to 16 Dec 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated, written Informed Consent Form (ICF) prior to any study-related procedures, sampling, and analyses (at Visit 1).
- Patient must be ≥18 years of age at the time of signing the ICF.
- A physician diagnosis of asthma for a minimum ≥6 months prior to Visit 1.
- Use of ICS (low or medium dose)/LABA for asthma for ≥3 months prior to Visit 1.
- Episode of asthma symptom worsening requiring overuse of reliever (more than the standard for the individual patient) at least once during the last 30 days prior to Visit 1.
- The patient must be able to read speak, and understand local language; and be able to, in the Investigator's judgment, comply with the study protocol.
Show all 12Show fewer
- Able to perform home FeNO and spirometry assessments and complete the asthma symptom diary on a regular basis during the conduct of the study.
- Male and/or female
- Negative pregnancy test (urine) for female patients of childbearing potential at Visit 1.
- For randomisation at Visit 2, patients should fulfil the following criteria:
- Symptoms requiring reliever medication use for a minimum of 2 to a maximum 8 days out of the last 10 days of the Run-in Period.
- At least 80% overall compliance rate for performing FeNO and spirometry assessments and completing the asthma symptom diary during the Run-in Period.
Who cannot join
- Any significant disease or disorder, or evidence of drug/substance abuse which in the Investigator's opinion would pose a risk to patient safety, interfere with the conduct of study, have an impact on the study results, or make it undesirable for the patient to participate in the study.
- Any asthma worsening requiring change in asthma treatment other than the patient's prescribed reliever medication (SYMBICORT as Maintenance and Reliever Therapy [SMART] therapy, SABA, and/or short-acting anticholinergic agent) within 30 days prior to Visit 1.
- Medical history of life- threatening asthma including intubation and intensive care unit admission.
- Medical conditions (other than allergic rhinitis) or medications (other than ICS) that will influence FeNO, as judged by the Investigator.
- Concurrent respiratory disease: presence of a known pre-existing, clinically important lung condition other than asthma (eg, cystic fibrosis, idiopathic pulmonary fibrosis, pulmonary arterial hypertension).
- Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained (Visit 1) or during the screening/Run-in Period.
Show all 20Show fewer
- A severe asthma exacerbation (defined by an exacerbation resulting in ≥3 days of oral corticosteroids [or one depot intramuscular injection of a glucocorticosteroid], an urgent care or emergency room visit that results in systemic corticosteroids, or an inpatient hospitalisation due to asthma) within 30 days prior to screening.
- Any disease state or procedure that may necessitate the use of oral/systemic corticosteroids during the Treatment Period, other than asthma.
- Malignancy: a current malignancy or previous history of cancer in remission for less than 12 months prior to Visit 1 (patients that had localised carcinoma of the skin which was resected for cure will not be excluded).
- Patients with a history/treatment of malignancy, and which in the Investigator's opinion could compromise the safety of the patient.
- Other concurrent medical conditions: patients who have known, pre-existing, clinically significant endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.
- Current smokers: previous smokers are allowed to be included provided that they stopped smoking >12 months prior to Visit 1 AND have a smoking history of ≤10 pack-years.
- Alcohol/substance abuse: a history (or suspected history) of alcohol misuse or substance abuse within 2 years prior to Visit 1.
- Participation in another clinical study with any marketed or investigational biologic drug within 4 months or 5 half-lives (whichever is longer) prior to Visit 1.
- Participation in another clinical study with a non-biologic investigational product or new formulation of a marketed non-biologic drug during the last 30 days prior to Visit 1.
- Patients with a known hypersensitivity to the study drugs or any of the excipients of the products.
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- Previous randomisation in the present study.
- For women only: currently pregnant (confirmed with positive pregnancy test), breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the Investigator. Periodic abstinence, spermicides only, and the lactational amenorrhoea method are not acceptable methods of contraception.
- Planned hospitalisation during the study that would interfere with study objectives as judged by the Investigator.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Research Site
Bradford, BD9 6RJ
Research Site
Dundee, DD1 9SY
Research Site
Nottingham, NG5 1PB
Research Site
Oxford
Research Site
Watford, WD18 0HB
Research Site
Wishaw, ML2 0DP
About this study
Official title: A 24-week Randomised Exploratory Open-Label Study Aiming To Characterise Changes In Airway Inflammation, Symptoms, Lung Function, And Reliever Use In Asthma Patients Using SABA (Salbutamol) Or Anti-Inflammatory Reliever (SYMBICORT®) As Rescue Medication In Addition To SYMBICORT As Daily Asthma Controller
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] at study entry
Read the detailed description
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. During the run-in period, patients will take their maintenance medication (ie, SYMBICORT [100/6 or 200/6 μg, × 2 BID]) and reliever salbutamol [100 μg, PRN]) using the connected inhalers. 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 ICS (low or medium) at study entry. This study will include a minimum of 3 site visits. Patients will be requested to come to the study site for 4 additional Event Visits (E1 to E4) at approximately 4-day intervals beginning after the first visit if they experience any one of the following 3 criteria: a) A severe exacerbation defined as use of systemic steroids for at least 3 days, emergency room visit, or inpatient hospitalisation due to asthma, b) Symptom worsening criteria based on CompEx evaluation - an asthma worsening identified by a combination of deteriorations in at least 2 variables (decrease in PEF of at least 15% compared with baseline, an increase of reliever medication of at least 1.5 occasions compared with baseline, or an increase in asthma symptoms of at least 1 compare with baseline or the absolute max score [=3]) at least 2 consecutive days, or c) A single day (in 24 hours) with 6 or more occasions of reliever medication use.
The duration of participation in the study will be 26 to 28 weeks (maximum) for each individual patient, including a 2-week Run-in Period, followed by a 24-week randomised Treatment Period and an additional follow-up period if the Event Visits fall within the final 2 weeks of the Treatment Period. The study plans to randomise a minimum of 60 patients to a maximum of 80 patients to achieve at least 54 patients completing the study. The study will be conducted at no less than 2 sites in the United Kingdom (UK). The estimated study duration is approximately 30 months.
- Conditions
- Airway Inflammation, Asthma
- Being tested
- SYMBICORT and salbutamol
- Keywords
- Airway inflammation, Anti-inflammatory reliever, SYMBICORT, Maintenance anti-inflammatory therapy, Reliever medication, Salbutamol
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYMBICORT and salbutamolCombination product
Also called VENTOLIN (salbutamol), SYMBICORT (budesonide/formoterol)
SYMBICORT will be given in a TURBOHALER. Salbutamol will be given in a pressurised metered dose inhaler.
| Study group | Role | What they receive |
|---|---|---|
| SYMBICORT as maintenance and reliever treatment | Active comparator | Patients on ICS (low dose)/LABA prior to study entry will receive SYMBICORT (budesonide/formoterol 100/6 μg) × 2 twice a day (BID) for maintenance and as needed (PRN) for relief and patients on ICS (medium dose)/LABA prior to study entry will receive SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance and PRN for relief. Receives: Combination Product: SYMBICORT and salbutamol |
| SYMBICORT as maintenance, salbutamol as reliever treatment | Active comparator | Patients on ICS (low dose)/LABA prior to study entry will receive SYMBICORT (budesonide/formoterol 100/6 μg) × 2 BID for maintenance + salbutamol (100 μg) PRN for relief and patients on ICS (medium dose)/LABA prior to study entry will receive SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance + salbutamol (100 μg) PRN for relief. Receives: Combination Product: SYMBICORT and salbutamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fractional Exhaled Nitric Oxide (FeNO)
FeNO was measured by the patient using a FeNO monitoring device (Vivatmo Me). Standard deviation of daily measurement of FeNO were presented for each patient and based on these summary statistics at treatment level were calculated.
Measured: From Day 1 to Day 169 (Treatment period)
Total Asthma Symptoms Score
Symptoms scores were calculated using the asthma symptom diary.
Asthma symptoms during daytime and night-time were recorded by the patient twice daily in the asthma symptom diary, according to the following scoring system:
0 = no asthma symptoms
- = you are aware of your asthma symptoms, but you can easily tolerate the symptoms
- = your asthma is causing you enough discomfort to cause problems with normal activities (or with sleep)
- = you are unable to do your normal activities (or to sleep) because of your asthma
Total asthma symptom scores were reported, which were calculated as the sum of non-missing morning and evening scores. Lower scores indicate no impairment/symptoms, representing increased asthma control. Conversely, higher scores indicate more severe impairment/symptoms, indicating reduced asthma control.
Standard deviation of total (daily) asthma symptom scores were presented for each patient and based on these summary statistics at treatment level were calculated.
Measured: From Day 1 to Day 169 (Treatment period)
Total Reliever Medication Use
Reliever medication usage was captured in the asthma symptom diary as the number of occasions the reliever inhaler was used. An occasion is defined as 2 puffs for salbutamol or 1 inhalation for SYMBICORT.
Standard deviation of total (daily) reliever medication use were presented for each patient and based on these summary statistics at treatment level were calculated.
Measured: From Day 1 to Day 169 (Treatment period)
Forced Expiratory Volume in 1 Second (FEV1) (Morning and Evening)
FEV1 was measured by the patient using a spirometry sensor (Spirobank Smart™). Standard deviation of daily measurement of FEV1 were presented for each patient and based on these summary statistics at treatment level were calculated.
Measured: From Day 1 to Day 169 (Treatment period)
Peak Expiratory Flow (PEF) (Morning and Evening)
PEF was measured by the patient using a spirometry sensor (Spirobank Smart™). Standard deviation of daily measurement of PEF were presented for each patient and based on these summary statistics at treatment level were calculated.
Measured: From Day 1 to Day 169 (Treatment period)
Secondary outcomes (2)
Number of Patients With Secondary Objective Events
The number of patients with inflammatory, asthma symptoms, lung function, and reliever use profile surrounding an event were assessed. Events of interest were Severe exacerbation (SevEx), composite surrogate endpoint for severe exacerbations of asthma (CompEx), and a single day (in 24 hours) with 6 or more occasions of reliever medication use.
CompEx is an extended definition of asthma exacerbations combining diary-based event with traditionally defined severe exacerbations.
Severe exacerbation are the events leading to one or more of the following; ≥ 3 days of oral corticosteroids (or one depot intramuscular injection of a glucocorticosteroid), an urgent care or emergency room visit that results in systemic corticosteroids, or an inpatient hospitalisation due to asthma.
Measured: From Day 1 to Day 169 (Treatment period)
Number of Secondary Objective Events
The inflammatory, asthma symptoms, lung function, and reliever use profile surrounding an event were assessed. Events of interest were Severe exacerbation (SevEx), composite surrogate endpoint for severe exacerbations of asthma (CompEx), and a single day (in 24 hours) with 6 or more occasions of reliever medication use.
CompEx is an extended definition of asthma exacerbations combining diary-based event with traditionally defined severe exacerbations.
Severe exacerbation are the events leading to one or more of the following; ≥ 3 days of oral corticosteroids (or one depot intramuscular injection of a glucocorticosteroid), an urgent care or emergency room visit that results in systemic corticosteroids, or an inpatient hospitalisation due to asthma.
Measured: From Day 1 to Day 169 (Treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start1 Aug 2019
- Primary completion16 Dec 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Airway InflammationStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924635
- Sponsor's protocol ID
- D589BC00018
- Other IDs
- 2018-003467-64, 2018
- Status last verified
- Dec 2024
- First submitted
- 31 Jan 2019
- Last updated
- 22 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week Randomised Exploratory Open-Label Study Aiming To Characterise Changes In Airway Inflammation, Symptoms, Lung Function, And Reliever Use In Asthma Patients Using SABA (Salbutamol) Or Anti-Inflammatory Reliever (SYMBICORT®) As Rescue Medication In Addition To SYMBICORT As Daily Asthma Controller
- ClinicalTrials.gov ID
- NCT03924635
- Acronym / sponsor ID
- D589BC00018
- Conditions
- Airway Inflammation, Asthma
- Keywords
- Airway inflammation, Anti-inflammatory reliever, SYMBICORT, Maintenance anti-inflammatory therapy, Reliever medication, Salbutamol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Posted 22 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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] at study entry
Detailed description
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. During the run-in period, patients will take their maintenance medication (ie, SYMBICORT [100/6 or 200/6 μg, × 2 BID]) and reliever salbutamol [100 μg, PRN]) using the connected inhalers. 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 ICS (low or medium) at study entry. This study will include a minimum of 3 site visits. Patients will be requested to come to the study site for 4 additional Event Visits (E1 to E4) at approximately 4-day intervals beginning after the first visit if they experience any one of the following 3 criteria: a) A severe exacerbation defined as use of systemic steroids for at least 3 days, emergency room visit, or inpatient hospitalisation due to asthma, b) Symptom worsening criteria based on CompEx evaluation - an asthma worsening identified by a combination of deteriorations in at least 2 variables (decrease in PEF of at least 15% compared with baseline, an increase of reliever medication of at least 1.5 occasions compared with baseline, or an increase in asthma symptoms of at least 1 compare with baseline or the absolute max score [=3]) at least 2 consecutive days, or c) A single day (in 24 hours) with 6 or more occasions of reliever medication use.
The duration of participation in the study will be 26 to 28 weeks (maximum) for each individual patient, including a 2-week Run-in Period, followed by a 24-week randomised Treatment Period and an additional follow-up period if the Event Visits fall within the final 2 weeks of the Treatment Period. The study plans to randomise a minimum of 60 patients to a maximum of 80 patients to achieve at least 54 patients completing the study. The study will be conducted at no less than 2 sites in the United Kingdom (UK). The estimated study duration is approximately 30 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYMBICORT as maintenance and reliever treatment | Active comparator | Combination Product: SYMBICORT and salbutamolPatients on ICS (low dose)/LABA prior to study entry will receive SYMBICORT (budesonide/formoterol 100/6 μg) × 2 twice a day (BID) for maintenance and as needed (PRN) for relief and patients on ICS (medium dose)/LABA prior to study entry will receive SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance and PRN for relief. |
| SYMBICORT as maintenance, salbutamol as reliever treatment | Active comparator | Combination Product: SYMBICORT and salbutamolPatients on ICS (low dose)/LABA prior to study entry will receive SYMBICORT (budesonide/formoterol 100/6 μg) × 2 BID for maintenance + salbutamol (100 μg) PRN for relief and patients on ICS (medium dose)/LABA prior to study entry will receive SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance + salbutamol (100 μg) PRN for relief. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provision of signed and dated, written Informed Consent Form (ICF) prior to any study-related procedures, sampling, and analyses (at Visit 1).
- Patient must be ≥18 years of age at the time of signing the ICF.
- A physician diagnosis of asthma for a minimum ≥6 months prior to Visit 1.
- Use of ICS (low or medium dose)/LABA for asthma for ≥3 months prior to Visit 1.
- Episode of asthma symptom worsening requiring overuse of reliever (more than the standard for the individual patient) at least once during the last 30 days prior to Visit 1.
Key exclusion criteria (20 listed)
- Any significant disease or disorder, or evidence of drug/substance abuse which in the Investigator's opinion would pose a risk to patient safety, interfere with the conduct of study, have an impact on the study results, or make it undesirable for the patient to participate in the study.
- Any asthma worsening requiring change in asthma treatment other than the patient's prescribed reliever medication (SYMBICORT as Maintenance and Reliever Therapy [SMART] therapy, SABA, and/or short-acting anticholinergic agent) within 30 days prior to Visit 1.
- Medical history of life- threatening asthma including intubation and intensive care unit admission.
- Medical conditions (other than allergic rhinitis) or medications (other than ICS) that will influence FeNO, as judged by the Investigator.
- Concurrent respiratory disease: presence of a known pre-existing, clinically important lung condition other than asthma (eg, cystic fibrosis, idiopathic pulmonary fibrosis, pulmonary arterial hypertension).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYMBICORT and salbutamolAlso: VENTOLIN (salbutamol), SYMBICORT (budesonide/formoterol)SYMBICORT will be given in a TURBOHALER. Salbutamol will be given in a pressurised metered dose inhaler. | Combination product | SYMBICORT as maintenance and reliever treatment, SYMBICORT as maintenance, salbutamol as reliever treatment |
Primary outcome
Fractional Exhaled Nitric Oxide (FeNO)
Time frame: From Day 1 to Day 169 (Treatment period)
FeNO was measured by the patient using a FeNO monitoring device (Vivatmo Me). Standard deviation of daily measurement of FeNO were presented for each patient and based on these summary statistics at treatment level were calculated.
Total Asthma Symptoms Score
Time frame: From Day 1 to Day 169 (Treatment period)
Symptoms scores were calculated using the asthma symptom diary. Asthma symptoms during daytime and night-time were recorded by the patient twice daily in the asthma symptom diary, according to the following scoring system: 0 = no asthma symptoms 1. = you are aware of your asthma symptoms, but you can easily tolerate the symptoms 2. = your asthma is causing you enough discomfort to cause problems with normal activities (or with sleep) 3. = you are unable to do your normal activities (or to sleep) because of your asthma Total asthma symptom scores were reported, which were calculated as the sum of non-missing morning and evening scores. Lower scores indicate no impairment/symptoms, representing increased asthma control. Conversely, higher scores indicate more severe impairment/symptoms, indicating reduced asthma control. Standard deviation of total (daily) asthma symptom scores were presented for each patient and based on these summary statistics at treatment level were calculated.
Total Reliever Medication Use
Time frame: From Day 1 to Day 169 (Treatment period)
Reliever medication usage was captured in the asthma symptom diary as the number of occasions the reliever inhaler was used. An occasion is defined as 2 puffs for salbutamol or 1 inhalation for SYMBICORT. Standard deviation of total (daily) reliever medication use were presented for each patient and based on these summary statistics at treatment level were calculated.
Forced Expiratory Volume in 1 Second (FEV1) (Morning and Evening)
Time frame: From Day 1 to Day 169 (Treatment period)
FEV1 was measured by the patient using a spirometry sensor (Spirobank Smart™). Standard deviation of daily measurement of FEV1 were presented for each patient and based on these summary statistics at treatment level were calculated.
Peak Expiratory Flow (PEF) (Morning and Evening)
Time frame: From Day 1 to Day 169 (Treatment period)
PEF was measured by the patient using a spirometry sensor (Spirobank Smart™). Standard deviation of daily measurement of PEF were presented for each patient and based on these summary statistics at treatment level were calculated.
2 secondary outcomes
Number of Patients With Secondary Objective Events
Time frame: From Day 1 to Day 169 (Treatment period)
Number of Secondary Objective Events
Time frame: From Day 1 to Day 169 (Treatment period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Related trials for Airway Inflammation
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Recruiting
Lung Immune Challenge Study: Controlled Exposure to Inhaled Resiquimod (R848)
Innate Immunity, Mucosal Immunity
RecruitingPhase 4
A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease.
Chronic Obstructive Pulmonary Disease
RecruitingObservational study
T2AIR: Real-World Efficacy and Safety of Biologics Targeting Type 2 Inflammation in Asthma and COPD
Asthma, COPD (Chronic Obstructive Pulmonary Disease)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SYMBICORT and salbutamol in people with Airway Inflammation and Asthma, run by AstraZeneca at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fractional Exhaled Nitric Oxide (FeNO) (time frame: From Day 1 to Day 169 (Treatment period)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.