Trial Outcomes & Findings for Asthma Biomarker Study (NCT NCT02392481)
NCT ID: NCT02392481
Last Updated: 2018-08-29
Results Overview
Level of Tumour Necrosis Factor-alpha (TNF-α) \[picograms per milliliter (pg/mL)\] in blood at baseline (Visit 1) is presented.
Recruitment status
COMPLETED
Target enrollment
69 participants
Primary outcome timeframe
Baseline (Visit 1)
Results posted on
2018-08-29
Participant Flow
This is a non-interventional, prospective, exploratory study. Asthma severity (mild, moderate or severe) was determined on the basis of medication use, spirometry (Forced Expiratory Volume in one second (FEV1) predicted values) and exacerbation history.
Participant milestones
| Measure |
Healthy Volunteers
This group consisted of all healthy volunteers aged between 18 and 70 years without any significant comorbid condition.
|
Mild Asthma
Patients with asthma are categorized as mild if they are taking Short-acting beta-agonist (SABA) or SABA/Short-acting muscarinic-antagonist (SAMA) per re nata (as required) (PRN), have no exacerbation in previous 12 months and have FEV1 ≥80 % of predicted.
|
Moderate Asthma
Patients with asthma are categorized as moderate if they are taking at least low dose Inhaled corticosteroid (iCS) ± 2nd controller, have no exacerbation in previous 12 months and have FEV1 ≥ 60 - ≤ 85 % of predicted.
|
Severe Asthma
Patients with asthma are categorized as severe if they are taking at least medium dose iCS ± 2nd controller and have at least 1 exacerbation (requiring treatment with systemic corticosteroids) in previous 12 months.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
20
|
27
|
|
Overall Study
COMPLETED
|
10
|
12
|
18
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Healthy Volunteers
This group consisted of all healthy volunteers aged between 18 and 70 years without any significant comorbid condition.
|
Mild Asthma
Patients with asthma are categorized as mild if they are taking Short-acting beta-agonist (SABA) or SABA/Short-acting muscarinic-antagonist (SAMA) per re nata (as required) (PRN), have no exacerbation in previous 12 months and have FEV1 ≥80 % of predicted.
|
Moderate Asthma
Patients with asthma are categorized as moderate if they are taking at least low dose Inhaled corticosteroid (iCS) ± 2nd controller, have no exacerbation in previous 12 months and have FEV1 ≥ 60 - ≤ 85 % of predicted.
|
Severe Asthma
Patients with asthma are categorized as severe if they are taking at least medium dose iCS ± 2nd controller and have at least 1 exacerbation (requiring treatment with systemic corticosteroids) in previous 12 months.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Asthma Biomarker Study
Baseline characteristics by cohort
| Measure |
Healthy Volunteers
n=10 Participants
This group consisted of all healthy volunteers aged between 18 and 70 years without any significant comorbid condition.
|
Mild Asthma
n=12 Participants
Patients with asthma are categorized as mild if they are taking Short-acting beta-agonist (SABA) or SABA/Short-acting muscarinic-antagonist (SAMA) per re nata (as required) (PRN), have no exacerbation in previous 12 months and have FEV1 ≥80 % of predicted.
|
Moderate Asthma
n=20 Participants
Patients with asthma are categorized as moderate if they are taking at least low dose Inhaled corticosteroid (iCS) ± 2nd controller, have no exacerbation in previous 12 months and have FEV1 ≥ 60 - ≤ 85 % of predicted.
|
Severe Asthma
n=27 Participants
Patients with asthma are categorized as severe if they are taking at least medium dose iCS ± 2nd controller and have at least 1 exacerbation (requiring treatment with systemic corticosteroids) in previous 12 months.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.3 Years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
36.1 Years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
44.9 Years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
50.2 Years
STANDARD_DEVIATION 13.6 • n=4 Participants
|
44.8 Years
STANDARD_DEVIATION 14.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (Visit 1)Population: Biomarker Subjects Set (BM) - All subjects, from the OBS \[subjects enrolled in the trial, following the receipt of informed consent, and are eligible to enter the observation period\], with at least one valid biomarker measurement either from blood or sputum at either visit.
Level of Tumour Necrosis Factor-alpha (TNF-α) \[picograms per milliliter (pg/mL)\] in blood at baseline (Visit 1) is presented.
Outcome measures
| Measure |
Healthy Volunteers
n=8 Participants
This group consisted of all healthy volunteers aged between 18 and 70 years without any significant comorbid condition.
|
Mild Asthma
n=10 Participants
Patients with asthma are categorized as mild if they are taking Short-acting beta-agonist (SABA) or SABA/Short-acting muscarinic-antagonist (SAMA) per re nata (as required) (PRN), have no exacerbation in previous 12 months and have FEV1 ≥80 % of predicted.
|
Moderate Asthma
n=13 Participants
Patients with asthma are categorized as moderate if they are taking at least low dose Inhaled corticosteroid (iCS) ± 2nd controller, have no exacerbation in previous 12 months and have FEV1 ≥ 60 - ≤ 85 % of predicted.
|
Severe Asthma
n=25 Participants
Patients with asthma are categorized as severe if they are taking at least medium dose iCS ± 2nd controller and have at least 1 exacerbation (requiring treatment with systemic corticosteroids) in previous 12 months.
|
|---|---|---|---|---|
|
Level of Tumour Necrosis Factor-alpha (TNF-α) in Blood at Baseline (Visit 1)
|
5.3 pg/mL
Standard Deviation 5.1
|
9.3 pg/mL
Standard Deviation 23.4
|
10.6 pg/mL
Standard Deviation 13.1
|
15.7 pg/mL
Standard Deviation 70.2
|
PRIMARY outcome
Timeframe: Baseline (Visit 1)Population: Biomarker Subjects Set (BM) - All subjects, from the OBS \[subjects enrolled in the trial, following the receipt of informed consent, and are eligible to enter the observation period\], with at least one valid biomarker measurement either from blood or sputum at either visit.
Level of Interleukin-6 (IL-6) (pg/mL) in blood at baseline (Visit 1) is presented.
Outcome measures
| Measure |
Healthy Volunteers
n=8 Participants
This group consisted of all healthy volunteers aged between 18 and 70 years without any significant comorbid condition.
|
Mild Asthma
n=10 Participants
Patients with asthma are categorized as mild if they are taking Short-acting beta-agonist (SABA) or SABA/Short-acting muscarinic-antagonist (SAMA) per re nata (as required) (PRN), have no exacerbation in previous 12 months and have FEV1 ≥80 % of predicted.
|
Moderate Asthma
n=13 Participants
Patients with asthma are categorized as moderate if they are taking at least low dose Inhaled corticosteroid (iCS) ± 2nd controller, have no exacerbation in previous 12 months and have FEV1 ≥ 60 - ≤ 85 % of predicted.
|
Severe Asthma
n=25 Participants
Patients with asthma are categorized as severe if they are taking at least medium dose iCS ± 2nd controller and have at least 1 exacerbation (requiring treatment with systemic corticosteroids) in previous 12 months.
|
|---|---|---|---|---|
|
Level of Interleukin-6 (IL-6) in Blood at Baseline (Visit 1)
|
71.3 pg/mL
Standard Deviation 109.0
|
65.2 pg/mL
Standard Deviation 88.2
|
245.0 pg/mL
Standard Deviation 426.3
|
133.9 pg/mL
Standard Deviation 639.5
|
SECONDARY outcome
Timeframe: follow-up visit 28 days after baseline (Visit 2)Population: Biomarker Subjects Set (BM) - All subjects, from the OBS \[subjects enrolled in the trial, following the receipt of informed consent, and are eligible to enter the observation period\], with at least one valid biomarker measurement either from blood or sputum at either visit.
Level of Tumour Necrosis Factor-alpha (TNF-α) (pg/mL) in blood at follow-up visit 28 days after baseline (Visit 2) is presented.
Outcome measures
| Measure |
Healthy Volunteers
n=10 Participants
This group consisted of all healthy volunteers aged between 18 and 70 years without any significant comorbid condition.
|
Mild Asthma
n=12 Participants
Patients with asthma are categorized as mild if they are taking Short-acting beta-agonist (SABA) or SABA/Short-acting muscarinic-antagonist (SAMA) per re nata (as required) (PRN), have no exacerbation in previous 12 months and have FEV1 ≥80 % of predicted.
|
Moderate Asthma
n=16 Participants
Patients with asthma are categorized as moderate if they are taking at least low dose Inhaled corticosteroid (iCS) ± 2nd controller, have no exacerbation in previous 12 months and have FEV1 ≥ 60 - ≤ 85 % of predicted.
|
Severe Asthma
n=25 Participants
Patients with asthma are categorized as severe if they are taking at least medium dose iCS ± 2nd controller and have at least 1 exacerbation (requiring treatment with systemic corticosteroids) in previous 12 months.
|
|---|---|---|---|---|
|
Level of Tumour Necrosis Factor-alpha (TNF-α) in Blood at Follow-up Visit 28 Days After Baseline (Visit 2)
|
5.8 pg/mL
Standard Deviation 9.6
|
8.1 pg/mL
Standard Deviation 14.7
|
5.2 pg/mL
Standard Deviation 5.5
|
16.4 pg/mL
Standard Deviation 65.6
|
SECONDARY outcome
Timeframe: follow-up visit 28 days after baseline (Visit 2)Population: Biomarker Subjects Set (BM) - All subjects, from the OBS \[subjects enrolled in the trial, following the receipt of informed consent, and are eligible to enter the observation period\], with at least one valid biomarker measurement either from blood or sputum at either visit.
Level of Interleukin-6 (IL-6) (pg/mL) in blood at follow-up visit 28 days after baseline (Visit 2) is presented.
Outcome measures
| Measure |
Healthy Volunteers
n=10 Participants
This group consisted of all healthy volunteers aged between 18 and 70 years without any significant comorbid condition.
|
Mild Asthma
n=12 Participants
Patients with asthma are categorized as mild if they are taking Short-acting beta-agonist (SABA) or SABA/Short-acting muscarinic-antagonist (SAMA) per re nata (as required) (PRN), have no exacerbation in previous 12 months and have FEV1 ≥80 % of predicted.
|
Moderate Asthma
n=16 Participants
Patients with asthma are categorized as moderate if they are taking at least low dose Inhaled corticosteroid (iCS) ± 2nd controller, have no exacerbation in previous 12 months and have FEV1 ≥ 60 - ≤ 85 % of predicted.
|
Severe Asthma
n=25 Participants
Patients with asthma are categorized as severe if they are taking at least medium dose iCS ± 2nd controller and have at least 1 exacerbation (requiring treatment with systemic corticosteroids) in previous 12 months.
|
|---|---|---|---|---|
|
Level of Interleukin-6 (IL-6) in Blood at Follow-up Visit 28 Days After Baseline (Visit 2)
|
47.7 pg/mL
Standard Deviation 59.7
|
86.1 pg/mL
Standard Deviation 107.6
|
105.1 pg/mL
Standard Deviation 94.1
|
37.4 pg/mL
Standard Deviation 113.8
|
Adverse Events
Healthy Volunteers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mild Asthma
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Moderate Asthma
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Severe Asthma
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER