Exacerbations in Severe Asthma Patients: Mechanisms and Biomarkers

NCT02660853 | Completed Results

• 1 other identifier: 13/LO/1198
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate exacerbations in severe asthma with regard to symptoms, lung function, aetiology and biomarkers.

Conditions

Asthma

Keywords

Exacerbations

Outcome Measures

Primary Outcomes (1)

• Percent Predicted FEV1

  From date of screening visit until date of first asthma exacerbation visit Percent predicted Forced Expiratory Volume in First Second

  Baseline Visit, 12 months

Secondary Outcomes (9)

• Exhaled Breath Condensate

  Baseline Visit, 12 months

• Markers of Oxidative Stress in Urine

  Baseline Visit, 12 months

• Markers of Oxidative Stress in Urine

  Baseline Visit, 12 months

• Sputum Analysis

  From baseline visit and 12 months

• PCR for Respiratory Viruses

  Baseline Visit, 12 months

Study Arms (1)

Severe Asthma

OTHER

Patients under Steps 4/5 of Asthma Treatment - SIGN (Scottish Intercollegiate Guidelines Network) / BTS (British Thoracic Society) Guidelines

Diagnostic Test: FEV1

Interventions

FEV1 DIAGNOSTIC_TEST

Participants have FEV1 test

Severe Asthma

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must be able to give informed consent. The definition of severe asthma will be 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).

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)

Biomedical research Unit, Royal Brompton Hospital, Sydney Street

London, SW3 6NP, United Kingdom

Location

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: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: January 21, 2016
• Study Start: June 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: December 3, 2019
• Results First Posted: October 31, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)