Exhaled Hydrogen Sulphide as a Biomarker of Airways Disease in Asthma

NCT02703467 | Completed Results

• 1 other identifier: 13/LO/1453
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Asthma

Keywords

Exhaled hydrogen sulphide

Outcome Measures

Primary Outcomes (1)

• Hydrogen Sulphide in Exhaled Breath

  Level of hydrogen sulphide in exhaled breath measured as parts per billion

  At baseline visit

Secondary Outcomes (4)

• FEV1

  At baseline visit

• FVC (Forced Vital Capacity)

  At 4 visits which occur during the study duration, up to 1 year

• Exhaled Nitric Oxide

  At 4 visits which occur during the study duration, up to 1 year

• Blood Hydrogen Sulpide Level

  At 4 visits which occur during the study duration, up to 1 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead
• Royal Brompton & Harefield NHS Foundation Trust: collaborator

Study Sites (1)

Royal Brompton Hospital

London, SW3 6HP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Professor Fan Chung
• Organization: Imperial College London

f.chung@imperial.ac.uk

00442075947954

Study Officials

• Kian F Chung, MBBS MD FRCP

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 9, 2016
• Study Start: August 1, 2015
• Primary Completion: June 30, 2016
• Study Completion: June 30, 2016
• Last Updated: October 21, 2019
• Results First Posted: October 21, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)