FLAME: Airway Inflammation Monitoring in Asthma and Cystic Fibrosis

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
Cystic Fibrosis Foundation
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00404859
First received: November 28, 2006
Last updated: November 30, 2006
Last verified: December 2005
  Purpose

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.


Condition
Asthma
Cystic Fibrosis

Study Type: Observational
Study Design: Allocation: Random Sample
Primary Purpose: Screening
Time Perspective: Longitudinal
Official Title: Monitoring Chronic Airway Inflammation in Children With Asthma and Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Estimated Enrollment: 70
Study Start Date: January 2006
Estimated Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   5 Years to 46 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Asthma is defined as a chronic inflammatory disorder, leading to recurrent episodes of wheezing, breathlessness, chest tightness, and/or coughing, based on variable airway obstruction [18]. Children with docter-diagnosed asthma known at the department of Paediatric Pulmonology, were recruited from the University Hospital Maastricht. Atopic and not atopic asthmatic children were allowed; treatment with inhalation corticosteroïd (ICS) was not obliged.
  • Children known with CF were recruited from University Hospital Maastricht. CF was defined as a combination of typical clinical features and an abnormal sweat test (Chloride > 60 mM). CF lung disease was treated according to the CBO consensus ref. Main aspects of treatment were:

    • antibiotic treatment,
    • agents to promote airway secretion clearance, such as DNase,
    • bronchodilators, and,
    • physiotherapy. All alternations of medical therapy were allowed and accurately documented.

Exclusion Criteria:

  • Diseases that may interfere with the results of the study (e.g. upper airway infection, cor vitium, anatomic abnormalities of the airway and other chronic inflammatory diseases, such as Morbus Crohn and rheumatoid arthritis),
  • Mental retardation,
  • Inability to perform measurements properly,
  • Active smoking and,
  • Use of the following medication: papaverin, sodium nitroprusside, angiotensin-converting enzyme (ACE) inhibitors, oxymetazoline, L-arginine, or nitric oxide synthase (NOS) inhibitors
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404859

Locations
Netherlands
Catharina Hospital
Eindhoven, Netherlands
University Hospital Maastricht
Maastricht, Netherlands, 6202AZ
St Radboud Childrens Hospital
Nijmegen, Netherlands
Máxima Medical Centre
Veldhoven, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
AstraZeneca
Cystic Fibrosis Foundation
Investigators
Principal Investigator: Charlotte M Robroeks, MD Maastricht University Medical Center
Study Director: Edward Dompeling, MD, PhD Maastricht University Medical Center
Study Director: Quirijn Jöbsis, MD, PhD Maastricht University Medical Center
  More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00404859     History of Changes
Other Study ID Numbers: MEC 05-114
Study First Received: November 28, 2006
Last Updated: November 30, 2006
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
inflammometry
exhaled breath condensate
fractional exhaled nitric oxide
asthma
cystic fibrosis
monitoring
exacerbations
paediatric

Additional relevant MeSH terms:
Asthma
Cystic Fibrosis
Fibrosis
Inflammation
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014