Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Exacerbations in Severe Asthma Patients: Mechanisms and Biomarkers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02660853
Recruitment Status : Completed
First Posted : January 21, 2016
Results First Posted : October 31, 2019
Last Update Posted : December 3, 2019
Sponsor:
Collaborator:
Royal Brompton & Harefield NHS Foundation Trust
Information provided by (Responsible Party):
Imperial College London

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Asthma
Intervention Diagnostic Test: FEV1
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Severe Asthma
Hide Arm/Group Description Patients under Steps 4/5 of Asthma Treatment - SIGN (Scottish Intercollegiate Guidelines Network) / BTS (British Thoracic Society) Guidelines, Observational study
Period Title: Overall Study
Started 25
Completed 25
Not Completed 0
Arm/Group Title Severe Asthma
Hide Arm/Group Description Patients under Steps 4/5 of Asthma Treatment - SIGN (Scottish Intercollegiate Guidelines Network) / BTS (British Thoracic Society) Guidelines
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
55.9  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
17
  68.0%
Male
8
  32.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 25 participants
25
1.Primary Outcome
Title Percent Predicted FEV1
Hide Description From date of screening visit until date of first asthma exacerbation visit Percent predicted Forced Expiratory Volume in First Second
Time Frame Baseline Visit, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Severe Asthma
Hide Arm/Group Description:
Patients under Steps 4/5 of Asthma Treatment - SIGN (Scottish Intercollegiate Guidelines Network) / BTS (British Thoracic Society) Guidelines
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: % of predicted value
baseline 58.6  (20.4)
During exacerbation 56.3  (22.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Severe Asthma
Comments Baseline versus during exacerbation.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.745
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Exhaled Breath Condensate
Hide Description pH and free Iron
Time Frame Baseline Visit, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
No data collected
Arm/Group Title Severe Asthma
Hide Arm/Group Description:
Patients under Steps 4/5 of Asthma Treatment - SIGN (Scottish Intercollegiate Guidelines Network) / BTS (British Thoracic Society) Guidelines
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Markers of Oxidative Stress in Urine
Hide Description malondialdehyde (MDA)
Time Frame Baseline Visit, 12 months
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Markers of Oxidative Stress in Urine
Hide Description 8-isoprostanes
Time Frame Baseline Visit, 12 months
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Sputum Analysis
Hide Description Eosinophils as percentage of total count
Time Frame From baseline visit and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Severe asthma at baseline
Arm/Group Title Severe Asthma
Hide Arm/Group Description:
Patients under Steps 4/5 of Asthma Treatment - SIGN (Scottish Intercollegiate Guidelines Network) / BTS (British Thoracic Society) Guidelines
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: Percentage of total sputum counts
Baseline 10.9  (30.6)
At exacerbation 4.47  (9.47)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Severe Asthma
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.326
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title PCR for Respiratory Viruses
Hide Description nasopharyngeal swabs
Time Frame Baseline Visit, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
No data collected
Arm/Group Title Severe Asthma
Hide Arm/Group Description:
Patients under Steps 4/5 of Asthma Treatment - SIGN (Scottish Intercollegiate Guidelines Network) / BTS (British Thoracic Society) Guidelines
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Sputum Microbiome
Hide Description [Not Specified]
Time Frame Baseline Visit, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
No data collected
Arm/Group Title Severe Asthma
Hide Arm/Group Description:
Patients under Steps 4/5 of Asthma Treatment - SIGN (Scottish Intercollegiate Guidelines Network) / BTS (British Thoracic Society) Guidelines
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Corticosteroid Insensitivity in Peripheral Blood Mononuclear Cells
Hide Description [Not Specified]
Time Frame Baseline Visit, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
No data collected
Arm/Group Title Severe Asthma
Hide Arm/Group Description:
Patients under Steps 4/5 of Asthma Treatment - SIGN (Scottish Intercollegiate Guidelines Network) / BTS (British Thoracic Society) Guidelines
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Exhaled Nitric Oxide
Hide Description [Not Specified]
Time Frame Baseline Visit, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Severe Asthma
Hide Arm/Group Description:
Patients under Steps 4/5 of Asthma Treatment - SIGN (Scottish Intercollegiate Guidelines Network) / BTS (British Thoracic Society) Guidelines
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Exhaled Hydrogen Sulphide
Hide Description [Not Specified]
Time Frame Baseline Visit, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected
Arm/Group Title Severe Asthma
Hide Arm/Group Description:
Patients under Steps 4/5 of Asthma Treatment - SIGN (Scottish Intercollegiate Guidelines Network) / BTS (British Thoracic Society) Guidelines
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Severe Asthma
Hide Arm/Group Description Patients under Steps 4/5 of Asthma Treatment - SIGN (Scottish Intercollegiate Guidelines Network) / BTS (British Thoracic Society) Guidelines
All-Cause Mortality
Severe Asthma
Affected / at Risk (%)
Total   0/25 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Severe Asthma
Affected / at Risk (%)
Total   0/25 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Severe Asthma
Affected / at Risk (%)
Total   0/25 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Professor Fan Chung
Organization: Imperial College London
Phone: 00442075947954
EMail: f.chung@imperial.ac.uk
Layout table for additonal information
Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02660853     History of Changes
Other Study ID Numbers: 13/LO/1198
First Submitted: November 2, 2015
First Posted: January 21, 2016
Results First Submitted: September 13, 2019
Results First Posted: October 31, 2019
Last Update Posted: December 3, 2019