Trial Outcomes & Findings for A Cross-sectional Study to Measure Cough in Severe Asthma (NCT NCT03999203)
NCT ID: NCT03999203
Last Updated: 2023-11-22
Results Overview
Objectively measure cough frequency (measured as hours per hour over a 24 hour monitoring period) in different phenotypes of severe asthma and a mild/moderate control group using a validated ambulatory cough monitor (Leicester Cough Monitor)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
Baseline
Results posted on
2023-11-22
Participant Flow
Participant milestones
| Measure |
A - T2 High Severe Asthmatics
Severe asthmatic patients with consistent eosinophil count ≥ 0.15x10\^9/mL and consistently high FeNO levels ≥20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
B - T2 Low Severe Asthmatics
Severe asthmatic patients with consistent eosinophil count ≤ 0.15x10\^9/mL and consistently low FeNO levels \<20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
C - Mild/Moderate Asthmatics
mild/moderate severe asthmatics (defined as step 2/3 using the GINA classification of severity) recruited from general respiratory clinics in the Belfast HSC Trust Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
D - T2 Intermediate
Severe asthmatic patients with consistent eosinophil count ≥ 0.15x10\^9/mL OR consistently high FeNO levels ≥20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
6
|
19
|
14
|
|
Overall Study
COMPLETED
|
22
|
6
|
19
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patient groups analysed seperately This was requested as per comments from review
Baseline characteristics by cohort
| Measure |
A - T2 High Severe Asthmatics
n=22 Participants
Severe asthmatic patients with consistent eosinophil count ≥ 0.15x10\^9/mL and consistently high FeNO levels ≥20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
B - T2 Low Severe Asthmatics
n=6 Participants
Severe asthmatic patients with consistent eosinophil count ≤ 0.15x10\^9/mL and consistently low FeNO levels \<20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
C - Mild/Moderate Asthmatics
n=19 Participants
mild/moderate severe asthmatics (defined as step 2/3 using the GINA classification of severity) recruited from general respiratory clinics in the Belfast HSC Trust Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
D - T2 Intermediate
n=14 Participants
Severe asthmatic patients with consistent eosinophil count ≥ 0.15x10\^9/mL OR consistently high FeNO levels ≥20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
Age
|
60 years
n=5 Participants • Patient groups analysed seperately This was requested as per comments from review
|
53.5 years
n=7 Participants • Patient groups analysed seperately This was requested as per comments from review
|
54 years
n=5 Participants • Patient groups analysed seperately This was requested as per comments from review
|
57 years
n=4 Participants • Patient groups analysed seperately This was requested as per comments from review
|
55.5 years
n=21 Participants • Patient groups analysed seperately This was requested as per comments from review
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
22 participants
n=5 Participants
|
6 participants
n=7 Participants
|
19 participants
n=5 Participants
|
14 participants
n=4 Participants
|
61 participants
n=21 Participants
|
|
BMI
|
30.4 kg/m^2
n=5 Participants • Patient groups analysed seperately This was requested as per comments from review
|
28.4 kg/m^2
n=7 Participants • Patient groups analysed seperately This was requested as per comments from review
|
26.3 kg/m^2
n=5 Participants • Patient groups analysed seperately This was requested as per comments from review
|
29.6 kg/m^2
n=4 Participants • Patient groups analysed seperately This was requested as per comments from review
|
29.0 kg/m^2
n=21 Participants • Patient groups analysed seperately This was requested as per comments from review
|
|
FEV1 (% predicted)
|
68.5 Percentage of predicted
n=5 Participants • Patient groups analysed seperately This was requested as per comments from review
|
87.0 Percentage of predicted
n=7 Participants • Patient groups analysed seperately This was requested as per comments from review
|
95 Percentage of predicted
n=5 Participants • Patient groups analysed seperately This was requested as per comments from review
|
80 Percentage of predicted
n=4 Participants • Patient groups analysed seperately This was requested as per comments from review
|
83.5 Percentage of predicted
n=21 Participants • Patient groups analysed seperately This was requested as per comments from review
|
PRIMARY outcome
Timeframe: BaselineObjectively measure cough frequency (measured as hours per hour over a 24 hour monitoring period) in different phenotypes of severe asthma and a mild/moderate control group using a validated ambulatory cough monitor (Leicester Cough Monitor)
Outcome measures
| Measure |
A - T2 High Severe Asthmatics
n=22 Participants
Severe asthmatic patients with consistent eosinophil count ≥ 0.15x10\^9/mL and consistently high FeNO levels ≥20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
B - T2 Low Severe Asthmatics
n=6 Participants
Severe asthmatic patients with consistent eosinophil count ≤ 0.15x10\^9/mL and consistently low FeNO levels \<20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
C - Mild/Moderate Asthmatics
n=19 Participants
mild/moderate severe asthmatics (defined as step 2/3 using the GINA classification of severity) recruited from general respiratory clinics in the Belfast HSC Trust Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
D - T2 Intermediate
n=14 Participants
Severe asthmatic patients with consistent eosinophil count ≥ 0.15x10\^9/mL OR consistently high FeNO levels ≥20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
|---|---|---|---|---|
|
Cough Frequency Measurement
|
6.6 coughs per hour over a 24 hour monitorin
Standard Deviation 2.6
|
2.7 coughs per hour over a 24 hour monitorin
Standard Deviation 1.6
|
2.5 coughs per hour over a 24 hour monitorin
Standard Deviation 4.1
|
12.7 coughs per hour over a 24 hour monitorin
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: BaselineTo objectively measure cough reflex sensitivity in different phenotypes of severe asthma and a mild.moderate control group using citric acid cough challenge testing. Patients are asked to inhale increasing concentrations of citric acid solutions and the cough response to each is measured in the 15 seconds following. The final outcome endpoint is described as the concentrations needed to cause 2 coughs (C2)
Outcome measures
| Measure |
A - T2 High Severe Asthmatics
n=22 Participants
Severe asthmatic patients with consistent eosinophil count ≥ 0.15x10\^9/mL and consistently high FeNO levels ≥20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
B - T2 Low Severe Asthmatics
n=6 Participants
Severe asthmatic patients with consistent eosinophil count ≤ 0.15x10\^9/mL and consistently low FeNO levels \<20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
C - Mild/Moderate Asthmatics
n=19 Participants
mild/moderate severe asthmatics (defined as step 2/3 using the GINA classification of severity) recruited from general respiratory clinics in the Belfast HSC Trust Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
D - T2 Intermediate
n=14 Participants
Severe asthmatic patients with consistent eosinophil count ≥ 0.15x10\^9/mL OR consistently high FeNO levels ≥20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
|---|---|---|---|---|
|
Cough Reflex Sensitivity (Citric Acid Cough Challenge)
|
0.125 M
Interval 0.03 to 0.38
|
0.25 M
Interval 0.03 to 2.25
|
0.139 M
Interval 0.03 to 0.4
|
0.125 M
Interval 0.05 to 0.25
|
SECONDARY outcome
Timeframe: BaselineAssessment of asthma control using subjective questionnaire (asthma control questionnaire) in different phenotypes of severe asthma. Patient responses graded on likert scale with an average score being calculated. A higher score indicates a worse level of asthma control. Score range 0-6
Outcome measures
| Measure |
A - T2 High Severe Asthmatics
n=22 Participants
Severe asthmatic patients with consistent eosinophil count ≥ 0.15x10\^9/mL and consistently high FeNO levels ≥20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
B - T2 Low Severe Asthmatics
n=6 Participants
Severe asthmatic patients with consistent eosinophil count ≤ 0.15x10\^9/mL and consistently low FeNO levels \<20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
C - Mild/Moderate Asthmatics
n=19 Participants
mild/moderate severe asthmatics (defined as step 2/3 using the GINA classification of severity) recruited from general respiratory clinics in the Belfast HSC Trust Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
D - T2 Intermediate
n=14 Participants
Severe asthmatic patients with consistent eosinophil count ≥ 0.15x10\^9/mL OR consistently high FeNO levels ≥20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
|---|---|---|---|---|
|
Asthma Control Questionnaire
|
1.9 Score
Interval 1.0 to 3.1
|
1.9 Score
Interval 0.3 to 2.4
|
0.6 Score
Interval 0.0 to 1.4
|
1.9 Score
Interval 1.0 to 3.1
|
SECONDARY outcome
Timeframe: BaselineAssesment of quality of life in asthma as perceived by the patient using this questionnaire in different phenotypes of severe asthma. Patient responses graded on likert scale with an average score being calculated. A higher score indicates a worse level of asthma related quality of life. Score range 1-7
Outcome measures
| Measure |
A - T2 High Severe Asthmatics
n=22 Participants
Severe asthmatic patients with consistent eosinophil count ≥ 0.15x10\^9/mL and consistently high FeNO levels ≥20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
B - T2 Low Severe Asthmatics
n=6 Participants
Severe asthmatic patients with consistent eosinophil count ≤ 0.15x10\^9/mL and consistently low FeNO levels \<20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
C - Mild/Moderate Asthmatics
n=19 Participants
mild/moderate severe asthmatics (defined as step 2/3 using the GINA classification of severity) recruited from general respiratory clinics in the Belfast HSC Trust Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
D - T2 Intermediate
n=14 Participants
Severe asthmatic patients with consistent eosinophil count ≥ 0.15x10\^9/mL OR consistently high FeNO levels ≥20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
|---|---|---|---|---|
|
Asthma Quality of Life Questionnaire
|
4.5 Score
Interval 2.5 to 5.5
|
4.8 Score
Interval 3.5 to 6.4
|
5.9 Score
Interval 5.3 to 6.6
|
4.7 Score
Interval 2.9 to 5.5
|
SECONDARY outcome
Timeframe: BaselineAssessment of quality of life in relation to cough in different phenotypes of severe asthma. Patient responses graded on likert scale with an average score being calculated from different symptoms domains wihtin the questionnaire. A lower score indicates a worse level of cough related quality of life. Score range 3-21
Outcome measures
| Measure |
A - T2 High Severe Asthmatics
n=22 Participants
Severe asthmatic patients with consistent eosinophil count ≥ 0.15x10\^9/mL and consistently high FeNO levels ≥20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
B - T2 Low Severe Asthmatics
n=6 Participants
Severe asthmatic patients with consistent eosinophil count ≤ 0.15x10\^9/mL and consistently low FeNO levels \<20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
C - Mild/Moderate Asthmatics
n=19 Participants
mild/moderate severe asthmatics (defined as step 2/3 using the GINA classification of severity) recruited from general respiratory clinics in the Belfast HSC Trust Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
D - T2 Intermediate
n=14 Participants
Severe asthmatic patients with consistent eosinophil count ≥ 0.15x10\^9/mL OR consistently high FeNO levels ≥20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
|---|---|---|---|---|
|
Leceister Cough Questionnaire
|
15.2 Score
Interval 11.1 to 18.5
|
18.7 Score
Interval 14.6 to 19.9
|
20 Score
Interval 17.0 to 20.5
|
14.2 Score
Interval 9.7 to 17.9
|
SECONDARY outcome
Timeframe: BaselineAssessment of quality of life in relation to cough in different phenotypes of severe asthma. Patient responses graded on likert scale with a total score being calculated. A higher score indicates a worse level of cough related quality of life. Score range 28-112
Outcome measures
| Measure |
A - T2 High Severe Asthmatics
n=22 Participants
Severe asthmatic patients with consistent eosinophil count ≥ 0.15x10\^9/mL and consistently high FeNO levels ≥20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
B - T2 Low Severe Asthmatics
n=6 Participants
Severe asthmatic patients with consistent eosinophil count ≤ 0.15x10\^9/mL and consistently low FeNO levels \<20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
C - Mild/Moderate Asthmatics
n=19 Participants
mild/moderate severe asthmatics (defined as step 2/3 using the GINA classification of severity) recruited from general respiratory clinics in the Belfast HSC Trust Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
D - T2 Intermediate
n=14 Participants
Severe asthmatic patients with consistent eosinophil count ≥ 0.15x10\^9/mL OR consistently high FeNO levels ≥20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
|---|---|---|---|---|
|
Cough Quality of Life Questionnaire
|
61 Score
Interval 53.0 to 68.3
|
57 Score
Interval 34.5 to 62.3
|
37 Score
Interval 28.0 to 62.0
|
56.5 Score
Interval 46.8 to 73.5
|
SECONDARY outcome
Timeframe: BaselineOutcome measures
| Measure |
A - T2 High Severe Asthmatics
n=22 Participants
Severe asthmatic patients with consistent eosinophil count ≥ 0.15x10\^9/mL and consistently high FeNO levels ≥20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
B - T2 Low Severe Asthmatics
n=6 Participants
Severe asthmatic patients with consistent eosinophil count ≤ 0.15x10\^9/mL and consistently low FeNO levels \<20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
C - Mild/Moderate Asthmatics
n=19 Participants
mild/moderate severe asthmatics (defined as step 2/3 using the GINA classification of severity) recruited from general respiratory clinics in the Belfast HSC Trust Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
D - T2 Intermediate
n=14 Participants
Severe asthmatic patients with consistent eosinophil count ≥ 0.15x10\^9/mL OR consistently high FeNO levels ≥20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
|---|---|---|---|---|
|
Fractional Exhaled Nitric Oxide (FeNO)
|
47 Parts per billion (ppb)
Interval 25.8 to 83.5
|
9.5 Parts per billion (ppb)
Interval 7.5 to 12.0
|
19 Parts per billion (ppb)
Interval 13.0 to 34.0
|
19 Parts per billion (ppb)
Interval 12.0 to 24.3
|
SECONDARY outcome
Timeframe: BaselineOutcome measures
| Measure |
A - T2 High Severe Asthmatics
n=22 Participants
Severe asthmatic patients with consistent eosinophil count ≥ 0.15x10\^9/mL and consistently high FeNO levels ≥20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
B - T2 Low Severe Asthmatics
n=6 Participants
Severe asthmatic patients with consistent eosinophil count ≤ 0.15x10\^9/mL and consistently low FeNO levels \<20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
C - Mild/Moderate Asthmatics
n=19 Participants
mild/moderate severe asthmatics (defined as step 2/3 using the GINA classification of severity) recruited from general respiratory clinics in the Belfast HSC Trust Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
D - T2 Intermediate
n=14 Participants
Severe asthmatic patients with consistent eosinophil count ≥ 0.15x10\^9/mL OR consistently high FeNO levels ≥20 ppb.
Interventions include 24 hour ambulatory cough monitoring (Leicester Cough Monitor), citric acid cough challenge, fractional exhaled nitric oxide (FeNO) testing, patient reported outcome measures and blood, urine and sputum sampling
Citric acid: Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitor: Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO): Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measures: A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
|
|---|---|---|---|---|
|
Blood Eosinophil Count
|
420 cells/ul
Interval 270.0 to 550.0
|
120 cells/ul
Interval 60.0 to 130.0
|
260 cells/ul
Interval 140.0 to 330.0
|
190 cells/ul
Interval 110.0 to 280.0
|
Adverse Events
A - T2 High Severe Asthmatics
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
B - T2 Low Severe Asthmatics
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
C - Mild/Moderate Asthmatics
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
D - T2 Intermediate
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place