None listed
Conditions
Interventions
Inhaled HFA-Beclomethasone Diproprionate (Qvar®) 200 mcg twice daily by aerochamber or a placebo (also inhaled by aerochamber).
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 1. CF-patients 10 years; 3. Use of anti-inflammatory therapy in a period of 2 months before inclusion (orally administered steroids, inhaled corticosteroïds and non-steroïd anti-inflammatory drugs, NSAID’s); 4. Disease, other than CF, that affects growth; 5. Participation in another study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PULMONARY: 1. FEV1, FVC, RV%TLC after 3 years; 2. Rint measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| IMMUNOLOGICAL: 1. Neutrophil markers: MoPhabs A17 and A27, CD11b, CD11a; 2. IL-8, sICAM1, sE-Selectin, TNFa; 3. End tidal carbon monoxide in exhaled breath; MICROBIOLOGICAL: 4. Respiratory pathogens in culture; SEROLOGICAL: 5. Seroconversion to anti-pseudomonal antibodies; Clinical: 6. Adverse events; 7. Clinical parameters (body weight, height, fat free mass); 8. Number of pulmonary acerbations; 9. Antimicrobial agent use; 10. Quality of life questionnaire scores; RADIOLOGICAL: 11. Chest radiograph scored by CF chest radiograph scoring systems. | — |
Contacts
Public ContactS.W.J. Terheggen-Lagro
University Medical Center Utrecht (UMCU), locatie AZU, CF-Centrum, P.O.Box 85500
Outcome results
None listed