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FLAME: Airway Inflammation Monitoring in Asthma and Cystic Fibrosis

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. Identifier: NCT00404859
Recruitment Status : Completed
First Posted : November 29, 2006
Last Update Posted : December 4, 2006
Cystic Fibrosis Foundation
Information provided by:
Maastricht University Medical Center

Brief Summary:

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 or disease
Asthma Cystic Fibrosis

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Study Type : Observational
Enrollment : 70 participants
Allocation: Random Sample
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Monitoring Chronic Airway Inflammation in Children With Asthma and Cystic Fibrosis
Study Start Date : January 2006
Study Completion Date : June 2007

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Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 46 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00404859

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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
Cystic Fibrosis Foundation
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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

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00404859     History of Changes
Other Study ID Numbers: MEC 05-114
First Posted: November 29, 2006    Key Record Dates
Last Update Posted: December 4, 2006
Last Verified: December 2005

Keywords provided by Maastricht University Medical Center:
exhaled breath condensate
fractional exhaled nitric oxide
cystic fibrosis

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