Asthma Clinical Trial
Official title:
Monitoring Chronic Airway Inflammation in Children With Asthma and Cystic Fibrosis
Background By means of measurements of series of non-invasive inflammatory markers in
exhaled breath (condensate), a reflection of inflammatory processes and oxidative stress,
can be obtained. Thereby, these techniques could be important in monitoring asthma and CF
lung disease in children. Fractional exhaled nitric oxide (FeNO) and inflammatory markers in
exhaled breath condensate (EBC) reflect ongoing inflammation and oxidative stress in the
airways. These markers have a promising capacity for monitoring diagnoses of CF and asthma
lung disease.
Aim To study the course of inflammatory markers in time in children with asthma and CF, in
stable periods and during pulmonary exacerbations. In addition, we study the ability of
inflammatory markers to predict safe tapering of medical treatment in both populations.
1. To study the course of inflammatory markers in EBC during an exacerbation.
2. To study which IM are already elevated before a clinical exacerbation is evident and
can predict exacerbations in time.
3. To study which inflammatory markers can predict safe discontinuation of antibiotics in
children with CF, or tapering of inhaled corticosteroids in children with asthma.
4. To study the relationship between inflammatory markers in EBC, the severity and control
of CF and asthma, the symptoms and lung function within patients will be analysed.
Methods Children with CF (n=30) and children with asthma (n=40) were recruited included from
our outpatient clinic. During this longitudinal study patients visit the outpatient clinic
were followed–up for 12 months; every two months during one year. patients visited our
outpatient clinic. In addition to these standard visits, During exacerbations patients four
extra visits were planned during an exacerbation. were asked to visit the University
Hospital Maastricht four times. These additional visits were planned with a maximum of two
times during the study. By means of a home monitor, children were asked to assess
measurements of Besides measurements in the University Hospital, children measured forced
expiratory volume in one second (FEV1) at home using a home monitor, to record medication
use, and, to record presence and severity of pulmonary symptoms. Outcome parameters were: 1)
FeNO assessment in exhaled air, 2) inflammatory markers in EBC, 3) lung function parameters,
4) specific questionnaires to assess asthma and CF control and severity, 5) data originating
from the home monitor.
n/a
Allocation: Random Sample, Primary Purpose: Screening, Time Perspective: Longitudinal
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04624425 -
Additional Effects of Segmental Breathing In Asthma
|
N/A | |
| Terminated |
NCT04410523 -
Study of Efficacy and Safety of CSJ117 in Patients With Severe Uncontrolled Asthma
|
Phase 2 | |
| Active, not recruiting |
NCT03927820 -
A Pharmacist-Led Intervention to Increase Inhaler Access and Reduce Hospital Readmissions (PILLAR)
|
N/A | |
| Completed |
NCT04617015 -
Defining and Treating Depression-related Asthma
|
Early Phase 1 | |
| Recruiting |
NCT03694158 -
Investigating Dupilumab's Effect in Asthma by Genotype
|
Phase 4 | |
| Terminated |
NCT04946318 -
Study of Safety of CSJ117 in Participants With Moderate to Severe Uncontrolled Asthma
|
Phase 2 | |
| Completed |
NCT04450108 -
Vivatmo Pro™ for Fractional Exhaled Nitric Oxide (FeNO) Monitoring in U.S. Asthmatic Patients
|
N/A | |
| Completed |
NCT03086460 -
A Dose Ranging Study With CHF 1531 in Subjects With Asthma (FLASH)
|
Phase 2 | |
| Completed |
NCT01160224 -
Oral GW766944 (Oral CCR3 Antagonist)
|
Phase 2 | |
| Completed |
NCT03186209 -
Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)
|
Phase 3 | |
| Completed |
NCT02502734 -
Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma
|
Phase 3 | |
| Completed |
NCT01715844 -
L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics
|
Phase 1 | |
| Terminated |
NCT04993443 -
First-In-Human Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of LQ036
|
Phase 1 | |
| Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
| Recruiting |
NCT06033833 -
Long-term Safety and Efficacy Evaluation of Subcutaneous Amlitelimab in Adult Participants With Moderate-to-severe Asthma Who Completed Treatment Period of Previous Amlitelimab Asthma Clinical Study
|
Phase 2 | |
| Completed |
NCT03257995 -
Pharmacodynamics, Safety, Tolerability, and Pharmacokinetics of Two Orally Inhaled Indacaterol Salts in Adult Subjects With Asthma.
|
Phase 2 | |
| Completed |
NCT02212483 -
Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients
|
N/A | |
| Recruiting |
NCT04872309 -
MUlti-nuclear MR Imaging Investigation of Respiratory Disease-associated CHanges in Lung Physiology
|
||
| Withdrawn |
NCT01468805 -
Childhood Asthma Reduction Study
|
N/A | |
| Recruiting |
NCT05145894 -
Differentiation of Asthma/COPD Exacerbation and Stable State Using Automated Lung Sound Analysis With LungPass Device
|