NCT03999203: CISA

A Cross-sectional Study to Measure Cough in Severe Asthma

Completed NA Results posted Last updated 22 November 2023

What this trial tests

NA trial testing Citric acid in Asthma in 61 participants. Completed in 30 December 2019.

Timeline

4 October 2017

Primary endpoint
30 December 2019

30 December 2019

Quick facts

Lead sponsor	Queen's University, Belfast
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	other
Enrollment	61
Start date	4 October 2017
Primary completion	30 December 2019
Estimated completion	30 December 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

• Citric acid (CITRIC ACID) — full drug profile →
• Leicester Cough monitor
• fractional exhaled nitric oxide testing (FeNO)
• Patient reported outcome measures

Conditions studied

• Asthma — all drugs for Asthma →
• Cough — all drugs for Cough →

Sponsor

Queen's University, Belfast

Who can join

Adults 18 to 75, any sex, with Asthma or Cough. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cough Frequency Measurement Primary · Baseline

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)

Group	Value	95% CI
A - T2 High Severe Asthmatics	6.6	± 2.6
B - T2 Low Severe Asthmatics	2.7	± 1.6
C - Mild/Moderate Asthmatics	2.5	± 4.1
D - T2 Intermediate	12.7	± 2.2

Cough Reflex Sensitivity (Citric Acid Cough Challenge) Primary · Baseline

To 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)

Group	Value	95% CI
A - T2 High Severe Asthmatics	0.125	0.03 – 0.38
B - T2 Low Severe Asthmatics	0.25	0.03 – 2.25
C - Mild/Moderate Asthmatics	0.139	0.03 – 0.40
D - T2 Intermediate	0.125	0.05 – 0.25

Asthma Control Questionnaire Secondary · Baseline

Assessment 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

Group	Value	95% CI
A - T2 High Severe Asthmatics	1.9	1 – 3.1
B - T2 Low Severe Asthmatics	1.9	0.3 – 2.4
C - Mild/Moderate Asthmatics	0.6	0 – 1.4
D - T2 Intermediate	1.9	1 – 3.1

Asthma Quality of Life Questionnaire Secondary · Baseline

Assesment 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

Group	Value	95% CI
A - T2 High Severe Asthmatics	4.5	2.5 – 5.5
B - T2 Low Severe Asthmatics	4.8	3.5 – 6.4
C - Mild/Moderate Asthmatics	5.9	5.3 – 6.6
D - T2 Intermediate	4.7	2.9 – 5.5

Leceister Cough Questionnaire Secondary · Baseline

Assessment 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

Group	Value	95% CI
A - T2 High Severe Asthmatics	15.2	11.1 – 18.5
B - T2 Low Severe Asthmatics	18.7	14.6 – 19.9
C - Mild/Moderate Asthmatics	20	17 – 20.5
D - T2 Intermediate	14.2	9.7 – 17.9

Cough Quality of Life Questionnaire Secondary · Baseline

Assessment 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

Group	Value	95% CI
A - T2 High Severe Asthmatics	61	53 – 68.3
B - T2 Low Severe Asthmatics	57	34.5 – 62.3
C - Mild/Moderate Asthmatics	37	28 – 62
D - T2 Intermediate	56.5	46.8 – 73.5

Fractional Exhaled Nitric Oxide (FeNO) Secondary · Baseline

Group	Value	95% CI
A - T2 High Severe Asthmatics	47	25.8 – 83.5
B - T2 Low Severe Asthmatics	9.5	7.5 – 12
C - Mild/Moderate Asthmatics	19	13 – 34
D - T2 Intermediate	19	12 – 24.3

Blood Eosinophil Count Secondary · Baseline

Group	Value	95% CI
A - T2 High Severe Asthmatics	420	270 – 550
B - T2 Low Severe Asthmatics	120	60 – 130
C - Mild/Moderate Asthmatics	260	140 – 330
D - T2 Intermediate	190	110 – 280

Sponsor's own description

This study aims to characterise cough in severe asthma through an observational cross-sectional analysis of patients stratified by inflammatory biomarker profile using a number of subjective and objective cough measurement tools.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.