AsthmaCISANCT03999203
A Cross-sectional Study to Measure Cough in Severe Asthma
A study testing Citric acid, Leicester Cough monitor and fractional exhaled nitric oxide testing (FeNO) in people with Asthma and Cough, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- Citric acid, Leicester Cough monitor and fractional exhaled nitric oxide testing (FeNO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Oct 2017to 30 Dec 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability and willingness to comply with the study procedures
- Age ≥18 to ≤75 years at the time of informed consent
- Severe asthma (as defined by GINA step 4/5 classification of asthma severity) after a detailed systematic assessment
- History of asthma treatment with high doses of Inhaled Corticosteroids (≥1000 µg beclomethasone dipropionate daily, or equivalent) and an additional controller
- Three patient groups with severe asthma will be investigated in the study and will be defined as follows:
- T2-High Severe Asthmatics (Group A)
Show all 18Show fewer
- Persistent blood eosinophil count ≥0.3x10^9/mL and
- Persistent high FeNO levels ≥30 ppb and
- Adherence to inhaled and oral corticosteroid therapy
- T2-Low Severe Asthmatics (Group B)
- Persistent blood eosinophil count ≤0.2x10^9/Ml and
- Persistent low FeNO levels (<30ppb)
- T2 - Intermediate Severe Asthmatics (Group D)
- Persistent blood eosinophil count ≥ 0.3x10^9/mL OR
- Persistent FeNO levels ≥ 30 ppb
- As stated above, these measurements are made at each clinic visit as part of routine care and will be available on all subjects prior to Inclusion
- A chest x-ray or CT scan obtained within 12 months before the time of informed consent and showing no new pathology requiring investigation as a potential cause for their cough
- Mild/moderate severe asthmatics (who have received a diagnosis of asthma from a physician and are defined as step 2/3 using the BTS/SIGN classification of severity and ACQ<1.5) aged 18-75 years inclusive will be recruited from general respiratory clinics in the Belfast HSC Trust. Patients must have the ability and willingness to comply with study procedures.
Who cannot join
- Baseline FEV1 ≤50% of predicted or ≤ 1.0L
- Asthma exacerbation within 28 days before the time of informed consent or during screening
- Major episode of infection requiring any of the following:
- Admission to hospital for ≥24 hours within the 28 days before the time of informed consent
- Treatment with intravenous antibiotics within the 28 days before the time of informed consent or during Screening
- Treatment with oral antibiotics within the 14 days before the time of informed consent or during Screening
Show all 17Show fewer
- For adults: Active tuberculosis (TB) requiring treatment within the 12 months before the time of informed consent (patients are also required to have no recurrence of symptoms in the 12 months following completion of TB treatment), or
- Known history of severe clinically significant immunodeficiency, including, but not limited to, human immunodeficiency virus infection and/or currently receiving or have historically received intravenous Ig for treatment for immunodeficiency Note: Immunodeficiency encompasses a wide spectrum of human conditions and/or diseases. A relative IgG deficiency that is thought, but not proven, to be a feature of severe asthma would not be exclusionary for the study.
- Diagnosis or history of malignancy, or current investigation for possible malignancy
- Other clinically significant medical disease that is uncontrolled despite treatment or that is likely, in the opinion of the investigator, to require a change in therapy or affect the ability to participate in the study
- History of alcohol, drug, or chemical abuse that would impair or risk the patient's full participation in the study, in the opinion of the investigator
- Current smoker or former smoker with a smoking history of >15 pack-years A current smoker is defined as someone who has smoked one or more cigarettes per day (or marijuana or pipe or cigar) for ≥30 days within the 24 months before the time of informed consent and for whom cotinine testing is positive.
- A former smoker is defined as someone who has smoked one or more cigarettes per day (or marijuana or pipe or cigar) for ≥30 days in his or her lifetime (as long as the 30-day total did not include the 24 months before the time of informed consent) and for whom cotinine testing is negative.
- A pack-year is defined as the average number of packs per day times the number of years of smoking.
- Initiation of or change in allergen immunotherapy within three months before the time of informed consent
- Treatment with an investigational agent within 30 days of informed consent or 5 half-lives of the investigational agent, whichever is longer
- Female patients who are pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This study will use a combination of subjective and objective cough measures to assess the frequency of cough as well as its related morbidity in severe asthmatics. Comparisons will be made between T2-High, T2-Low and T2-intermediate patients defined using a composite biomarker profile (blood eosinophil count and FeNO) to assess the role of cough in each and these results will be compared to the transcriptomic and proteomic measurements in the RASP-UK where the same biomarker profiling is being used to define clinical sub-groups of severe asthma. This study aims to also improve characterisation of the T2-Low population and identify possible mechanisms for the pathophysiology of this group.
60 patients are expected to be recruited to the study. Patients will be provided with an information sheet and have a telephone follow-up after at least 24 hours to ask if they remain interested in participation and if so, they will then be asked back for a baseline visit.
Three groups of severe asthmatics will be recruited (as described in appropriate section) and undergo the following procedures:
- Demographic details, height, weight, spirometry, FeNO and vital signs
- Patient reported outcomes:
- Asthma Mini-Asthma Quality of Life Questionnaire (mini-AQLQ) - abbreviated version of Juniper AQLQ
- Asthma Control Questionnaire (ACQ-5 (5 questions);
- Leicester Cough Questionnaire, the Cough-specific quality-of-life Questionnaire and Cough Hypersensitivity Questionnaire will be used to assess the impact of cough;
- Visual analogue scales (VAS) for cough (VASc) and urge to cough (VASu) will be used as a measure of cough severity.
- Blood samples - a sample of blood will be taken for whole blood transcriptomic and serum analyses
- Citric acid cough challenge test will be used to measure cough reflex sensitivity in each phenotype.
- Spontaneous sputum sample - if patients produce a sputum sample during spirometry or citric acid challenge, this will be recorded and the sample will be retained for sputum differential cell count and storage of processed soluble components.
- On completing the above procedures, patients will be asked to wear a validated ambulatory cough monitor (Leicester Cough Monitor) for a 24-hour period to assess the frequency of cough and if they agree, will be fully instructed in its use.
Patients will be asked to attend a follow-up visit 2 weeks after baseline. The study procedures will remain the same as visit 1 with the exception of collection of clinical samples.
A mild/moderate population will be recruited and undergo the same procedures as the severe group in a baseline visit. No mild/moderate asthmatics will be asked to attend for a follow-up visit.
- Being tested
- Citric acid, Leicester Cough monitor, fractional exhaled nitric oxide testing (FeNO), Patient reported outcome measures
- Medical subject headings
- Asthma, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Citric acidDrug
Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
Leicester Cough monitorDevice
Ambulatory cough monitor to assess cough frequency over a 24 hour period
fractional exhaled nitric oxide testing (FeNO)Other
Measurement of exhaled nitric oxide to give an indication of airway inflammation
Patient reported outcome measuresOther
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)
| Study group | Role | What they receive |
|---|---|---|
| A - T2 High Severe Asthmatics | Active comparator | Severe asthmatic patients with eosinophil count ≥ 0.15x10^9/mL andhigh 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 Receives: Drug: Citric acid; Device: Leicester Cough monitor; Other: fractional exhaled nitric oxide testing (FeNO); Other: Patient reported outcome measures |
| B - T2 Low Severe Asthmatics | Active comparator | Severe asthmatic patients with eosinophil count ≤ 0.15x10^9/mL and 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 Receives: Drug: Citric acid; Device: Leicester Cough monitor; Other: fractional exhaled nitric oxide testing (FeNO); Other: Patient reported outcome measures |
| C - Mild/Moderate Asthmatics | Active comparator | 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 Receives: Drug: Citric acid; Device: Leicester Cough monitor; Other: fractional exhaled nitric oxide testing (FeNO); Other: Patient reported outcome measures |
| D - T2 Intermediate | Active comparator | Severe asthmatic patients with eosinophil count ≥ 0.15x10^9/mL OR 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 Receives: Drug: Citric acid; Device: Leicester Cough monitor; Other: fractional exhaled nitric oxide testing (FeNO); Other: Patient reported outcome measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough Frequency Measurement
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)
Measured: Baseline
Cough Reflex Sensitivity (Citric Acid Cough Challenge)
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)
Measured: Baseline
Secondary outcomes (6)
Asthma Control Questionnaire
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
Measured: Baseline
Asthma Quality of Life Questionnaire
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
Measured: Baseline
Leceister Cough Questionnaire
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
Measured: Baseline
Cough Quality of Life Questionnaire
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
Measured: Baseline
Fractional Exhaled Nitric Oxide (FeNO)
Measured: Baseline
Blood Eosinophil Count
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start4 Oct 2017
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London
- Responsible party
- Principal investigator, Liam Heaney, Queen's University, Belfast
- Investigators
- Liam Heaney, MD, Principal investigator, Queen's University, BelfastLorcan McGarvey, MD, Study chair, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999203
- Sponsor's protocol ID
- B17/03
- Acronym
- CISA
- Status last verified
- Feb 2023
- First submitted
- 12 Apr 2018
- Last updated
- 22 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study to Measure Cough in Severe Asthma
- ClinicalTrials.gov ID
- NCT03999203
- Acronym / sponsor ID
- CISA / B17/03
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- King's College London
- Study start
- 4 Oct 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 26 Jun 2019 (actual)
- Results
- Posted 22 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will use a combination of subjective and objective cough measures to assess the frequency of cough as well as its related morbidity in severe asthmatics. Comparisons will be made between T2-High, T2-Low and T2-intermediate patients defined using a composite biomarker profile (blood eosinophil count and FeNO) to assess the role of cough in each and these results will be compared to the transcriptomic and proteomic measurements in the RASP-UK where the same biomarker profiling is being used to define clinical sub-groups of severe asthma. This study aims to also improve characterisation of the T2-Low population and identify possible mechanisms for the pathophysiology of this group.
60 patients are expected to be recruited to the study. Patients will be provided with an information sheet and have a telephone follow-up after at least 24 hours to ask if they remain interested in participation and if so, they will then be asked back for a baseline visit.
Three groups of severe asthmatics will be recruited (as described in appropriate section) and undergo the following procedures:
- Demographic details, height, weight, spirometry, FeNO and vital signs
- Patient reported outcomes:
- Asthma Mini-Asthma Quality of Life Questionnaire (mini-AQLQ) - abbreviated version of Juniper AQLQ
- Asthma Control Questionnaire (ACQ-5 (5 questions);
- Leicester Cough Questionnaire, the Cough-specific quality-of-life Questionnaire and Cough Hypersensitivity Questionnaire will be used to assess the impact of cough;
- Visual analogue scales (VAS) for cough (VASc) and urge to cough (VASu) will be used as a measure of cough severity.
- Blood samples - a sample of blood will be taken for whole blood transcriptomic and serum analyses
- Citric acid cough challenge test will be used to measure cough reflex sensitivity in each phenotype.
- Spontaneous sputum sample - if patients produce a sputum sample during spirometry or citric acid challenge, this will be recorded and the sample will be retained for sputum differential cell count and storage of processed soluble components.
- On completing the above procedures, patients will be asked to wear a validated ambulatory cough monitor (Leicester Cough Monitor) for a 24-hour period to assess the frequency of cough and if they agree, will be fully instructed in its use.
Patients will be asked to attend a follow-up visit 2 weeks after baseline. The study procedures will remain the same as visit 1 with the exception of collection of clinical samples.
A mild/moderate population will be recruited and undergo the same procedures as the severe group in a baseline visit. No mild/moderate asthmatics will be asked to attend for a follow-up visit.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A - T2 High Severe Asthmatics | Active comparator | Drug: Citric acid, Device: Leicester Cough monitor, Other: fractional exhaled nitric oxide testing (FeNO), Other: Patient reported outcome measuresSevere asthmatic patients with eosinophil count ≥ 0.15x10^9/mL andhigh 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 |
| B - T2 Low Severe Asthmatics | Active comparator | Drug: Citric acid, Device: Leicester Cough monitor, Other: fractional exhaled nitric oxide testing (FeNO), Other: Patient reported outcome measuresSevere asthmatic patients with eosinophil count ≤ 0.15x10^9/mL and 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 |
| C - Mild/Moderate Asthmatics | Active comparator | Drug: Citric acid, Device: Leicester Cough monitor, Other: fractional exhaled nitric oxide testing (FeNO), Other: Patient reported outcome measuresmild/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 |
| D - T2 Intermediate | Active comparator | Drug: Citric acid, Device: Leicester Cough monitor, Other: fractional exhaled nitric oxide testing (FeNO), Other: Patient reported outcome measuresSevere asthmatic patients with eosinophil count ≥ 0.15x10^9/mL OR 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Ability and willingness to comply with the study procedures
- Age ≥18 to ≤75 years at the time of informed consent
- Severe asthma (as defined by GINA step 4/5 classification of asthma severity) after a detailed systematic assessment
- History of asthma treatment with high doses of Inhaled Corticosteroids (≥1000 µg beclomethasone dipropionate daily, or equivalent) and an additional controller
- Three patient groups with severe asthma will be investigated in the study and will be defined as follows:
Key exclusion criteria (17 listed)
- Baseline FEV1 ≤50% of predicted or ≤ 1.0L
- Asthma exacerbation within 28 days before the time of informed consent or during screening
- Major episode of infection requiring any of the following:
- For adults: Active tuberculosis (TB) requiring treatment within the 12 months before the time of informed consent (patients are also required to have no recurrence of symptoms in the 12 months following completion of TB treatment), or
- Known history of severe clinically significant immunodeficiency, including, but not limited to, human immunodeficiency virus infection and/or currently receiving or have historically received intravenous Ig for treatment for immunodeficiency Note: Immunodeficiency encompasses a wide spectrum of human conditions and/or diseases. A relative IgG deficiency that is thought, but not proven, to be a feature of severe asthma would not be exclusionary for the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Citric acidCitric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients | Drug | A - T2 High Severe Asthmatics, B - T2 Low Severe Asthmatics, C - Mild/Moderate Asthmatics, D - T2 Intermediate |
| Leicester Cough monitorAmbulatory cough monitor to assess cough frequency over a 24 hour period | Device | A - T2 High Severe Asthmatics, B - T2 Low Severe Asthmatics, C - Mild/Moderate Asthmatics, D - T2 Intermediate |
| fractional exhaled nitric oxide testing (FeNO)Measurement of exhaled nitric oxide to give an indication of airway inflammation | Other | A - T2 High Severe Asthmatics, B - T2 Low Severe Asthmatics, C - Mild/Moderate Asthmatics, D - T2 Intermediate |
| Patient reported outcome measuresA 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) | Other | A - T2 High Severe Asthmatics, B - T2 Low Severe Asthmatics, C - Mild/Moderate Asthmatics, D - T2 Intermediate |
Primary outcome
Cough Frequency Measurement
Time frame: 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)
Cough Reflex Sensitivity (Citric Acid Cough Challenge)
Time frame: 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)
6 secondary outcomes
Asthma Control Questionnaire
Time frame: Baseline
Asthma Quality of Life Questionnaire
Time frame: Baseline
Leceister Cough Questionnaire
Time frame: Baseline
Cough Quality of Life Questionnaire
Time frame: Baseline
Fractional Exhaled Nitric Oxide (FeNO)
Time frame: Baseline
Blood Eosinophil Count
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Asthma
Active, not recruitingPhase 1
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Asthma
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
Asthma
RecruitingPhase 3
A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)
Asthma
Not yet recruitingPhase 4
Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liam Heaney, MD principal investigator
Queen's University, Belfast
Lorcan McGarvey, MD study chair
Queen's University, Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Citric acid, Leicester Cough monitor and fractional exhaled nitric oxide testing (FeNO) in people with Asthma and Cough, run by Queen's University, Belfast at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough Frequency Measurement (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.