AsthmaNCT02703467
Exhaled Hydrogen Sulphide as a Biomarker of Airways Disease in Asthma
An observational study of Asthma, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The purpose of this study will be to determine whether there is any role for measuring Hydrogen Sulphide (H2S) in the exhaled breath in terms of management of the patient with asthma. The investigators will recruit patients with a range of severity of asthma and health volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2015to 30 Jun 2016
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators will recruit a cohort healthy subjects by advertisement within the Hospital and within the general public (by newspaper advertisement). The investigators will also recruit subjects with asthma from paients attending Asthma Clinics at the Royal Brompton and Harefiled NHS Trust.
Who may be able to join
- All patients must be able to give informed consent. The definition of the severity of their asthma will be according to the GINA (Global Initiative for Asthma) guidelines dependent on the amount of therapy needed to control asthma. The investigators will also include at least 45 patients with severe asthma defined on the basis of: Uncontrolled asthma: three or more of the following features present in any week in the previous 4 weeks:
- Daytime symptoms more than twice per week
- Any limitation of activities
- Nocturnal symptoms once or more per week
- Need for reliever treatment more than twice per week
- Pre bronchodilator FEV1 <80% predicted or personal best OR
Show all 14Show fewer
- Frequent severe exacerbations (≥2 per year) OR
- Require prescription of daily or alternate day oral corticosteroids (OCS) to achieve asthma control despite the prescription of high dose inhaled corticosteroids (>1000mcg fluticasone propionate daily or equivalent) or maintenance oral corticosteroids plus a long acting beta agonist or one other controller medication (for example anti-cholinergics, leukotriene receptor antagonists or theophylline).
- Diagnosis of asthma for the asthma cohort: Subjects must have asthma according to one or more of the following criteria documented in the last 12 months
- improvement in FEV1 ≥ 12% and 200ml predicted after inhalation of 400 mcg salbutamol
- airway hyper-responsiveness (PC20 <8mg/ml)
- diurnal variation in PEF: amplitude % mean of twice daily PEF > 8%
- decrease in pre bronchodilator FEV1 >12% and >200mls within 4 weeks after tapering treatment with one or more of the following drugs: inhaled corticosteroids, oral corticosteroids, long-acting beta-agonists, long-acting beta-agonists and short-acting beta-agonists.
- PLUS a history of wheeze occurring spontaneously or on exertion
Who cannot join
- Current smoker, or Ex-smoker with a >10 year pack history or having smoked within the past 6 months.
- Significant alternative diagnoses that may mimic or complicate asthma, in particular dysfunctional breathing, panic attacks, and overt psychosocial problems (if these are thought to be the major problem rather than in addition to severe asthma)
- Significant other primary pulmonary disorders in particular pulmonary embolism, pulmonary hypertension, interstitial lung disease and lung cancer
- Subjects with emphysema and bronchiectasis should only be excluded if this is thought to be the major pulmonary disorder rather than in addition to severe asthma
- Diagnosis or current investigation of occupational asthma
- Any subjects currently participating, or having participated within 3 months of the first dose in a study using a new molecular entity, or the first dose in any other study investigating drugs.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study will be to determine whether there is any role for measuring Hydrogen Sulphide (H2S) in the exhaled breath in terms of management of the patient with asthma.
The investigators will recruit patients with a range of severity of asthma and health volunteers. Levels of Hydrogen Sulphide will be measured in exhaled breath and blood. Also exhaled Nitric Oxide, Spirometry and asthma symptom scores will be measured at each study visit. Participants will attend either 2 or 4 separate visits.
The investigators will determine whether there is a relationship between exhaled Hydrogen Sulphide and asthma severity.
Read the detailed description
Objectives:
- Perform a cross-sectional study in non-asthmatic subjects and asthmatic subjects of varying severities of the levels of Hydrogen Sulphide in exhaled breath in relation to the severity and control of asthma
- Compare the levels of exhaled Hydrogen Sulphide with exhaled Nitric Oxide.
We will recruit 30 health volunteers and 90 patients with a range of severity of asthma.
Particpants will attend for either 2 or 4 visits. At these visits the following measurements will be taken:
- Exhaled Hydrogen Sulphide
- Serum Hydrogen Sulphide
- Exhaled Nitric Oxide 3. Spirometry 4. Asthma Symptom Score (ACQ)
The investigators will use a Hydrogen Sulphide UV fluorescent machine Model T101 (0-50 ppb to 0-20 ppm) (Cal-Bay Control Inc, USA) to measure directly on line exhaled breath Hydrogen Sulphide. This method has been used previously in normal people, but we will first determine whether there is an exhaled flow-dependence on the measurement of H2S levels. The investigators will use a hand-held Nitric Oxide machine (NO Breath) to measure Nitric Oxide in exhaled breath.
Subjects must have asthma according to one or more of the following criteria documented in the last 12 months:
- Improvement in FEV1 (forced expiratory volume at one second) ≥ 12% and 200ml predicted after inhalation of 400 mcg salbutamol
- Airway hyper-responsiveness (PC20 <8mg/ml)
- Diurnal variation in PEF (peak expiratory flow): amplitude % mean of twice daily PEF > 8%
- Decrease in pre-bronchodilator FEV1 >12% and >200mls within 4 weeks after tapering treatment with one or more of the following drugs: inhaled corticosteroids, oral corticosteroids, long-acting beta-agonists, long-acting beta-agonists and short-acting beta-agonists.
PLUS A history of wheeze occurring spontaneously or on exertion
- Conditions
- Asthma
- Keywords
- Exhaled hydrogen sulphide
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Healthy subjects will have no significant medical history and no previous history of asthma or other serious illnesses. They should be non-smokers. The investigators willl measure spirometry and ensure that the values lie within the normal predicted range. | |
| Asthmatics | Patients diagnosed as having asthma will be recruited from Royal Brompton Hospital Asthma Clinics. These patients will have a range of severity of asthma ranging from mild-moderate to severe asthma patients. The diagnosis of asthma is ascertained as described in the inclusion criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydrogen Sulphide in Exhaled Breath
Level of hydrogen sulphide in exhaled breath measured as parts per billion
Measured: At baseline visit
Secondary outcomes (4)
FEV1
Forced expiratory volume in one second as percent of predicted value (%)
Measured: At baseline visit
FVC (Forced Vital Capacity)
Forced vital capacity as per cent of predicted
Measured: At 4 visits which occur during the study duration, up to 1 year
Exhaled Nitric Oxide
Levels of nitric oxide in exhaled breath in parts per billion
Measured: At 4 visits which occur during the study duration, up to 1 year
Blood Hydrogen Sulpide Level
Hydrogen Sulpide level measurements from blood
Measured: At 4 visits which occur during the study duration, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study start1 Aug 2015
- Primary completion30 Jun 2016
- Study completion30 Jun 2016
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.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Kian F Chung, MBBS MD FRCP, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703467
- Sponsor's protocol ID
- 13/LO/1453
- Status last verified
- Oct 2019
- First submitted
- 23 Feb 2016
- Last updated
- 21 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Hydrogen Sulphide as a Biomarker of Airways Disease in Asthma
- ClinicalTrials.gov ID
- NCT02703467
- Acronym / sponsor ID
- 13/LO/1453
- Conditions
- Asthma
- Keywords
- Exhaled hydrogen sulphide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Jun 2016 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Posted 21 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study will be to determine whether there is any role for measuring Hydrogen Sulphide (H2S) in the exhaled breath in terms of management of the patient with asthma.
The investigators will recruit patients with a range of severity of asthma and health volunteers. Levels of Hydrogen Sulphide will be measured in exhaled breath and blood. Also exhaled Nitric Oxide, Spirometry and asthma symptom scores will be measured at each study visit. Participants will attend either 2 or 4 separate visits.
The investigators will determine whether there is a relationship between exhaled Hydrogen Sulphide and asthma severity.
Detailed description
Objectives:
- Perform a cross-sectional study in non-asthmatic subjects and asthmatic subjects of varying severities of the levels of Hydrogen Sulphide in exhaled breath in relation to the severity and control of asthma
- Compare the levels of exhaled Hydrogen Sulphide with exhaled Nitric Oxide.
We will recruit 30 health volunteers and 90 patients with a range of severity of asthma.
Particpants will attend for either 2 or 4 visits. At these visits the following measurements will be taken:
- Exhaled Hydrogen Sulphide
- Serum Hydrogen Sulphide
- Exhaled Nitric Oxide 3. Spirometry 4. Asthma Symptom Score (ACQ)
The investigators will use a Hydrogen Sulphide UV fluorescent machine Model T101 (0-50 ppb to 0-20 ppm) (Cal-Bay Control Inc, USA) to measure directly on line exhaled breath Hydrogen Sulphide. This method has been used previously in normal people, but we will first determine whether there is an exhaled flow-dependence on the measurement of H2S levels. The investigators will use a hand-held Nitric Oxide machine (NO Breath) to measure Nitric Oxide in exhaled breath.
Subjects must have asthma according to one or more of the following criteria documented in the last 12 months:
- Improvement in FEV1 (forced expiratory volume at one second) ≥ 12% and 200ml predicted after inhalation of 400 mcg salbutamol
- Airway hyper-responsiveness (PC20 <8mg/ml)
- Diurnal variation in PEF (peak expiratory flow): amplitude % mean of twice daily PEF > 8%
- Decrease in pre-bronchodilator FEV1 >12% and >200mls within 4 weeks after tapering treatment with one or more of the following drugs: inhaled corticosteroids, oral corticosteroids, long-acting beta-agonists, long-acting beta-agonists and short-acting beta-agonists.
PLUS A history of wheeze occurring spontaneously or on exertion
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | –Healthy subjects will have no significant medical history and no previous history of asthma or other serious illnesses. They should be non-smokers. The investigators willl measure spirometry and ensure that the values lie within the normal predicted range. |
| Asthmatics | – | –Patients diagnosed as having asthma will be recruited from Royal Brompton Hospital Asthma Clinics. These patients will have a range of severity of asthma ranging from mild-moderate to severe asthma patients. The diagnosis of asthma is ascertained as described in the inclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will recruit a cohort healthy subjects by advertisement within the Hospital and within the general public (by newspaper advertisement). The investigators will also recruit subjects with asthma from paients attending Asthma Clinics at the Royal Brompton and Harefiled NHS Trust.
Key inclusion criteria (14 listed)
- All patients must be able to give informed consent. The definition of the severity of their asthma will be according to the GINA (Global Initiative for Asthma) guidelines dependent on the amount of therapy needed to control asthma. The investigators will also include at least 45 patients with severe asthma defined on the basis of: Uncontrolled asthma: three or more of the following features present in any week in the previous 4 weeks:
- Daytime symptoms more than twice per week
- Any limitation of activities
- Nocturnal symptoms once or more per week
- Need for reliever treatment more than twice per week
Key exclusion criteria (6 listed)
- Current smoker, or Ex-smoker with a >10 year pack history or having smoked within the past 6 months.
- Significant alternative diagnoses that may mimic or complicate asthma, in particular dysfunctional breathing, panic attacks, and overt psychosocial problems (if these are thought to be the major problem rather than in addition to severe asthma)
- Significant other primary pulmonary disorders in particular pulmonary embolism, pulmonary hypertension, interstitial lung disease and lung cancer
- Subjects with emphysema and bronchiectasis should only be excluded if this is thought to be the major pulmonary disorder rather than in addition to severe asthma
- Diagnosis or current investigation of occupational asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hydrogen Sulphide in Exhaled Breath
Time frame: At baseline visit
Level of hydrogen sulphide in exhaled breath measured as parts per billion
4 secondary outcomes
FEV1
Time frame: At baseline visit
FVC (Forced Vital Capacity)
Time frame: At 4 visits which occur during the study duration, up to 1 year
Exhaled Nitric Oxide
Time frame: At 4 visits which occur during the study duration, up to 1 year
Blood Hydrogen Sulpide Level
Time frame: At 4 visits which occur during the study duration, up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kian F Chung, MBBS MD FRCP principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Imperial College London 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 14 inclusion and 6 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 21 Oct 2019. 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 21 Oct 2019). 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?
Hydrogen Sulphide in Exhaled Breath (time frame: At baseline visit). 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 21 Oct 2019.