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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR91 |
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Date of registration:
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26/07/2005 |
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Primary sponsor: |
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Public title:
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Cystic fibrosis; a hereditary inflammatory process.
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Scientific title:
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Cystic fibrosis; a hereditary inflammatory process. - N/A |
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Date of first enrolment:
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1/1/2002 |
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Target sample size:
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60 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=91 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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S.W.J.
Terheggen-Lagro |
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Address:
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University Medical Center Utrecht (UMCU), locatie AZU, CF-Centrum,
P.O.Box 85500, Heidelberglaan 100
3508 GA
Utrecht
The Netherlands |
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Telephone:
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+31 (0)30 2504000 |
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Email:
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s.terheggen@umcutrecht.nl |
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Affiliation:
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Name:
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S.W.J.
Terheggen-Lagro |
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Address:
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University Medical Center Utrecht (UMCU), locatie AZU, CF-Centrum,
P.O.Box 85500, Heidelberglaan 100
3508 GA
Utrecht
The Netherlands |
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Telephone:
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+31 (0)30 2504000 |
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Email:
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s.terheggen@umcutrecht.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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: 1. CF-patients < 2 years;
2. 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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis (CF)
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Intervention(s)
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Inhaled HFA-Beclomethasone Diproprionate (Qvar®) 200 mcg twice daily by aerochamber or a placebo (also inhaled by aerochamber).
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Primary Outcome(s)
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PULMONARY:
1. FEV1, FVC, RV%TLC after 3 years;
2. Rint measurements.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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ISRCTN03484127
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N/A
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Source(s) of Monetary Support
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Netherlands Organization for Scientific Research (NWO)
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