N/A
N=25
Exacerbations in Severe Asthma Patients: Mechanisms and Biomarkers
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02660853 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Percent Predicted FEV1 — 58.6; 56.3 % of predicted value — p=0.745
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FEV1 (Diagnostic_test)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Predicted FEV1 |
58.6; 56.3 | 0.745 |
| SECONDARY Exhaled Breath Condensate |
— | — |
| SECONDARY Markers of Oxidative Stress in Urine |
— | — |
| SECONDARY Markers of Oxidative Stress in Urine |
— | — |
| SECONDARY Sputum Analysis |
10.9; 4.47 | 0.326 |
| SECONDARY PCR for Respiratory Viruses |
— | — |
| SECONDARY Sputum Microbiome |
— | — |
| SECONDARY Corticosteroid Insensitivity in Peripheral Blood Mononuclear Cells |
— | — |
| SECONDARY Exhaled Nitric Oxide |
— | — |
| SECONDARY Exhaled Hydrogen Sulphide |
— | — |
Summary
The purpose of this study is to investigate exacerbations in severe asthma with regard to symptoms, lung function, aetiology and biomarkers.
Eligibility Criteria
Inclusion Criteria
- 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 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).
Exclusion Criteria
- • 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.
Data sourced from ClinicalTrials.gov (NCT02660853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.