FLAME: Airway Inflammation Monitoring in Asthma and Cystic Fibrosis

NCT00404859 | Completed

• 1 other identifier: MEC 05-114
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 4

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. 1.To study the course of inflammatory markers in EBC during an exacerbation.
2. 2.To study which IM are already elevated before a clinical exacerbation is evident and can predict exacerbations in time.
3. 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. 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.

Conditions

Asthma; Cystic Fibrosis

Keywords

inflammometry; exhaled breath condensate; fractional exhaled nitric oxide; asthma; cystic fibrosis; monitoring; exacerbations; paediatric

Eligibility Criteria

• Age: 5 Years - 46 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• AstraZeneca: collaborator
• Cystic Fibrosis Foundation: collaborator

Study Sites (4)

Catharina Hospital

Eindhoven, Netherlands

Location

University Hospital Maastricht

Maastricht, 6202AZ, Netherlands

Location

St Radboud Childrens Hospital

Nijmegen, Netherlands

Location

Máxima Medical Centre

Veldhoven, Netherlands

Location

Related Publications (1)

• Robroeks CM, van Berkel JJ, Jobsis Q, van Schooten FJ, Dallinga JW, Wouters EF, Dompeling E. Exhaled volatile organic compounds predict exacerbations of childhood asthma in a 1-year prospective study. Eur Respir J. 2013 Jul;42(1):98-106. doi: 10.1183/09031936.00010712. Epub 2013 May 3.

  PMID: 23645402 DERIVED

MeSH Terms

Conditions

Asthma; Cystic Fibrosis

Condition Hierarchy (Ancestors)

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; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Charlotte M Robroeks, MD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

• Edward Dompeling, MD, PhD

  Maastricht University Medical Center

  STUDY DIRECTOR

• Quirijn Jöbsis, MD, PhD

  Maastricht University Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 28, 2006
• First Posted: November 29, 2006
• Study Start: January 1, 2006
• Study Completion: June 1, 2007
• Last Updated: December 4, 2006

Record last verified: 2005-12

Locations

NL (4)