Trial Outcomes & Findings for An Exploratory Study to Characterise Changes in Airway Inflammation, Symptoms, Lung Function and Reliever Use in Adult Asthma Patients (NCT NCT03924635)
NCT ID: NCT03924635
Last Updated: 2025-01-22
Results Overview
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.
COMPLETED
PHASE4
42 participants
From Day 1 to Day 169 (Treatment period)
2025-01-22
Participant Flow
This study was conducted at six study sites in United Kingdom between 01 August 2019 and 16 December 2022.
Eligible patients from the screening visit entered the 14-day run-in period during which they used 4 devices (1 spirometry sensor, 1 FeNO device, and 2 inhaler sensors) connected to the STIFLE App. The Investigator (or trained study staff) ensured all devices were connected properly and instructed patients on how to use each device and the STIFLE App prior to the run-in period.
Participant milestones
| Measure |
SYMBICORT as Maintenance and Reliever Treatment
Patients on ICS (low dose)/LABA prior to study entry received 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 received SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance and PRN for relief.
|
SYMBICORT as Maintenance, Salbutamol as Reliever Treatment
Patients on ICS (low dose)/LABA prior to study entry received 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 received SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance + salbutamol (100 μg) PRN for relief.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
24
|
|
Overall Study
COMPLETED
|
16
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
SYMBICORT as Maintenance and Reliever Treatment
Patients on ICS (low dose)/LABA prior to study entry received 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 received SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance and PRN for relief.
|
SYMBICORT as Maintenance, Salbutamol as Reliever Treatment
Patients on ICS (low dose)/LABA prior to study entry received 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 received SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance + salbutamol (100 μg) PRN for relief.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
Baseline Characteristics
An Exploratory Study to Characterise Changes in Airway Inflammation, Symptoms, Lung Function and Reliever Use in Adult Asthma Patients
Baseline characteristics by cohort
| Measure |
SYMBICORT as Maintenance and Reliever Treatment
n=18 Participants
Patients on ICS (low dose)/LABA prior to study entry received 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 received SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance and PRN for relief.
|
SYMBICORT as Maintenance, Salbutamol as Reliever Treatment
n=24 Participants
Patients on ICS (low dose)/LABA prior to study entry received 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 received SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance + salbutamol (100 μg) PRN for relief.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 Years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
45.5 Years
STANDARD_DEVIATION 16.0 • n=7 Participants
|
49.2 Years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From Day 1 to Day 169 (Treatment period)Population: The FAS was defined as all patients randomised who had at least 1 post baseline measurement, irrespective of their protocol adherence and continued participation in the study.
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.
Outcome measures
| Measure |
SYMBICORT as Maintenance and Reliever Treatment
n=18 Participants
Patients on ICS (low dose)/LABA prior to study entry received 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 received SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance and PRN for relief.
|
SYMBICORT as Maintenance, Salbutamol as Reliever Treatment
n=24 Participants
Patients on ICS (low dose)/LABA prior to study entry received 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 received SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance + salbutamol (100 μg) PRN for relief.
|
|---|---|---|
|
Fractional Exhaled Nitric Oxide (FeNO)
|
8.67 parts per billion (ppb)
Interval 3.25 to 23.97
|
9.01 parts per billion (ppb)
Interval 2.28 to 18.58
|
PRIMARY outcome
Timeframe: From Day 1 to Day 169 (Treatment period)Population: The FAS was defined as all patients randomised who had at least 1 post baseline measurement, irrespective of their protocol adherence and continued participation in the study.
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.
Outcome measures
| Measure |
SYMBICORT as Maintenance and Reliever Treatment
n=18 Participants
Patients on ICS (low dose)/LABA prior to study entry received 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 received SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance and PRN for relief.
|
SYMBICORT as Maintenance, Salbutamol as Reliever Treatment
n=24 Participants
Patients on ICS (low dose)/LABA prior to study entry received 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 received SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance + salbutamol (100 μg) PRN for relief.
|
|---|---|---|
|
Total Asthma Symptoms Score
|
0.58 Score on a scale
Interval 0.08 to 1.26
|
0.83 Score on a scale
Interval 0.0 to 1.47
|
PRIMARY outcome
Timeframe: From Day 1 to Day 169 (Treatment period)Population: The FAS was defined as all patients randomised who had at least 1 post baseline measurement, irrespective of their protocol adherence and continued participation in the study.
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.
Outcome measures
| Measure |
SYMBICORT as Maintenance and Reliever Treatment
n=18 Participants
Patients on ICS (low dose)/LABA prior to study entry received 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 received SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance and PRN for relief.
|
SYMBICORT as Maintenance, Salbutamol as Reliever Treatment
n=24 Participants
Patients on ICS (low dose)/LABA prior to study entry received 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 received SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance + salbutamol (100 μg) PRN for relief.
|
|---|---|---|
|
Total Reliever Medication Use
|
0.75 Number of Occasions
Interval 0.0 to 1.47
|
1.16 Number of Occasions
Interval 0.31 to 2.75
|
PRIMARY outcome
Timeframe: From Day 1 to Day 169 (Treatment period)Population: The FAS was defined as all patients randomised who had at least 1 post baseline measurement, irrespective of their protocol adherence and continued participation in the study.
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.
Outcome measures
| Measure |
SYMBICORT as Maintenance and Reliever Treatment
n=18 Participants
Patients on ICS (low dose)/LABA prior to study entry received 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 received SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance and PRN for relief.
|
SYMBICORT as Maintenance, Salbutamol as Reliever Treatment
n=24 Participants
Patients on ICS (low dose)/LABA prior to study entry received 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 received SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance + salbutamol (100 μg) PRN for relief.
|
|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) (Morning and Evening)
Morning
|
0.169 Liter (L)
Interval 0.078 to 0.386
|
0.188 Liter (L)
Interval 0.089 to 0.576
|
|
Forced Expiratory Volume in 1 Second (FEV1) (Morning and Evening)
Evening
|
0.165 Liter (L)
Interval 0.079 to 0.361
|
0.197 Liter (L)
Interval 0.087 to 0.722
|
PRIMARY outcome
Timeframe: From Day 1 to Day 169 (Treatment period)Population: The FAS was defined as all patients randomised who had at least 1 post baseline measurement, irrespective of their protocol adherence and continued participation in the study.
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.
Outcome measures
| Measure |
SYMBICORT as Maintenance and Reliever Treatment
n=18 Participants
Patients on ICS (low dose)/LABA prior to study entry received 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 received SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance and PRN for relief.
|
SYMBICORT as Maintenance, Salbutamol as Reliever Treatment
n=24 Participants
Patients on ICS (low dose)/LABA prior to study entry received 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 received SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance + salbutamol (100 μg) PRN for relief.
|
|---|---|---|
|
Peak Expiratory Flow (PEF) (Morning and Evening)
Morning
|
30.92 Liter/minute (L/minute)
Interval 16.2 to 59.51
|
36.28 Liter/minute (L/minute)
Interval 19.89 to 73.16
|
|
Peak Expiratory Flow (PEF) (Morning and Evening)
Evening
|
30.17 Liter/minute (L/minute)
Interval 18.19 to 56.81
|
35.61 Liter/minute (L/minute)
Interval 22.86 to 79.42
|
SECONDARY outcome
Timeframe: From Day 1 to Day 169 (Treatment period)Population: The FAS was defined as all patients randomised who had at least 1 post baseline measurement, irrespective of their protocol adherence and continued participation in the study.
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.
Outcome measures
| Measure |
SYMBICORT as Maintenance and Reliever Treatment
n=18 Participants
Patients on ICS (low dose)/LABA prior to study entry received 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 received SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance and PRN for relief.
|
SYMBICORT as Maintenance, Salbutamol as Reliever Treatment
n=24 Participants
Patients on ICS (low dose)/LABA prior to study entry received 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 received SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance + salbutamol (100 μg) PRN for relief.
|
|---|---|---|
|
Number of Patients With Secondary Objective Events
SevEx events
|
2 Participants
|
7 Participants
|
|
Number of Patients With Secondary Objective Events
A single day (in 24 hours) with 6 or more occasions of reliever medication use
|
3 Participants
|
9 Participants
|
|
Number of Patients With Secondary Objective Events
CompEx events
|
4 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 169 (Treatment period)Population: The FAS was defined as all patients randomised who had at least 1 post baseline measurement, irrespective of their protocol adherence and continued participation in the study.
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.
Outcome measures
| Measure |
SYMBICORT as Maintenance and Reliever Treatment
n=18 Participants
Patients on ICS (low dose)/LABA prior to study entry received 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 received SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance and PRN for relief.
|
SYMBICORT as Maintenance, Salbutamol as Reliever Treatment
n=24 Participants
Patients on ICS (low dose)/LABA prior to study entry received 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 received SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance + salbutamol (100 μg) PRN for relief.
|
|---|---|---|
|
Number of Secondary Objective Events
SevEx events
|
2 Number of events
|
8 Number of events
|
|
Number of Secondary Objective Events
CompEx events
|
8 Number of events
|
15 Number of events
|
|
Number of Secondary Objective Events
A single day (in 24 hours) with 6 or more occasions of reliever medication use
|
3 Number of events
|
18 Number of events
|
Adverse Events
SYMBICORT as Maintenance and Reliever Treatment
SYMBICORT as Maintenance, Salbutamol as Reliever Treatment
Serious adverse events
| Measure |
SYMBICORT as Maintenance and Reliever Treatment
n=18 participants at risk
Patients on ICS (low dose)/LABA prior to study entry received 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 received SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance and PRN for relief.
|
SYMBICORT as Maintenance, Salbutamol as Reliever Treatment
n=24 participants at risk
Patients on ICS (low dose)/LABA prior to study entry received 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 received SYMBICORT (budesonide/formoterol 200/6 μg) × 2 BID for maintenance + salbutamol (100 μg) PRN for relief.
|
|---|---|---|
|
Infections and infestations
Central nervous system infection
|
0.00%
0/18 • From Run-in period (Day -14 to -1) up to premature discontinuation visit and last Event Visit (Day 169)
|
4.2%
1/24 • Number of events 1 • From Run-in period (Day -14 to -1) up to premature discontinuation visit and last Event Visit (Day 169)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee This document contains trade secrets and confidential commercial information, disclosure of which is prohibited without providing advance notice to AstraZeneca and opportunity to object.
- Publication restrictions are in place
Restriction type: OTHER