Status:
COMPLETED
FLAME: Airway Inflammation Monitoring in Asthma and Cystic Fibrosis
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
AstraZeneca
Cystic Fibrosis Foundation
Conditions:
Asthma
Cystic Fibrosis
Eligibility:
All Genders
5-46 years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
OBSERVATIONAL
End Date :
June 1 2007
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00404859
Start Date
January 1 2006
End Date
June 1 2007
Last Update
December 4 2006
Active Locations (4)
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1
Catharina Hospital
Eindhoven, Netherlands
2
University Hospital Maastricht
Maastricht, Netherlands, 6202AZ
3
St Radboud Childrens Hospital
Nijmegen, Netherlands
4
Máxima Medical Centre
Veldhoven, Netherlands