Cystic fibrosis: a hereditary inflammatory process

Completed

Conditions: Cystic fibrosis
Nutritional, Metabolic, Endocrine

Registration Number: ISRCTN03484127

Lead Sponsor: niversity Medical Centre Utrecht (UMCU) (The Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

For 3-years randomised controlled trial:
1. CF diagnosis as confirmed by sweat chloride test and/or genotyping
2. CF-patients 2 - 10 years old
3. Informed consent
4. Capable of using inhaled corticosteroids by aerochamber
5. Compliant to regular therapy

Exclusion Criteria

For 3-years randomised controlled trial:
1. CF-patients less than 2 years
2. CF-patients greater than 10 years
3. Use of anti-inflammatory therapy in a period of 2 months before inclusion (orally administered steroids, inhaled corticosteroids and non-steroid anti-inflammatory drugs, non-steroidal anti-inflammatory drugs [NSAIDs])
4. Disease, other than CF, that affects growth
5. Participation in another study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulmonary<br>1. Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), residual volume (RV)/total lung capacity (TLC) % after 3 years<br>2. Rint measurements

Secondary Outcome Measures

Name	Time	Method
Immunological:<br>1. Neutrophil markers: MoPhabs A17 and A27, CD11b, CD11a<br>2. Interleukin-8 (IL-8), soluble intercellular adhesion molecule 1 (sICAM1), sE-Selectin, tumour necrotising factor alpha (TNFa)<br>3. End tidal carbon monoxide in exhaled breath<br><br>Microbiological:<br>1. Respiratory pathogens in culture<br> <br>Serological:<br>1. Seroconversion to anti-pseudomonal antibodies<br><br>Clinical: <br>1. Adverse events<br>2. Clinical parameters (body weight, height, fat free mass)<br>3. Number of pulmonary exacerbations<br>4. Antimicrobial agent use<br>5. Quality of life questionnaire scores<br><br>Radiological:<br>1. Chest radiograph scored by CF chest radiograph scoring systems