Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/09/2005
Date assigned
12/09/2005
Last edited
17/09/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr S W J Terheggen-Lagro

ORCID ID

Contact details

Universitair Medisch Centrum
locatie AZU
CF-Centrum
Huispostnummer B03.237
P.O.Box 85500
Utrecht
3508 GA
Netherlands
+31 (0)30 250 4000
s.terheggen@umcutrecht.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR91

Study information

Scientific title

Acronym

Study hypothesis

One out of 3600 new-born children in the Netherlands has cystic fibrosis (CF). It is an autosomal recessive disease and about 70% of the Dutch CF-patients are homozygous for the delta-F508 mutation. Although the genetic mutation is identical in this group of patients, the pulmonary disease is very diverse. Causative factors are environmental and also co-genetic ones. Morbidity is caused by chronic inflammation and infection of the lungs, which leads to irreversible lung damage.

Neutrophils play a key role in the inflammatory cascade. It is assumed that parts of the acute inflammatory response of the neutrophil (chemotaxis/IL8 ± adhesion/selectines ± activation/TNFa ± production of e.g. superoxides or myeloperoxidase ±tissue destruction) play an important role in the inflammatory process in CF. There is a higher concentration of mediators (IL-8, sICAM1, sE-Selectin, TNFa) in patients with CF than in other patients with airway infections. The CFTR protein acts not only as a Cl channel but also as a Na/H antiport and influences the intracellular pH. This might affect the functional activity of the neutrophil. Recently, new activation markers (MoPhabs A17 and A27) located on leukocytes were described that may be an early sign of pulmonary inflammation. To be able to predict and intervene in the inflammatory process would improve the prognosis especially in young children before the process of irreversible lung damage.

The use of new and powerful inhaled corticosteroid medication enables us to give anti-inflammatory therapy to young children without the systemic side-effects of orally administered steroids.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, double blind, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Cystic fibrosis

Intervention

Inhaled HFA-Beclomethasone Diproprionate (Qvar®) 200 mcg twice daily by aerochamber or a placebo (also inhaled by aerochamber).

Intervention type

Drug

Phase

Not Specified

Drug names

Inhaled HFA-Beclomethasone Diproprionate

Primary outcome measures

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

Secondary outcome measures

Immunological:
1. Neutrophil markers: MoPhabs A17 and A27, CD11b, CD11a
2. Interleukin-8 (IL-8), soluble intercellular adhesion molecule 1 (sICAM1), sE-Selectin, tumour necrotising factor alpha (TNFa)
3. End tidal carbon monoxide in exhaled breath

Microbiological:
1. Respiratory pathogens in culture

Serological:
1. Seroconversion to anti-pseudomonal antibodies

Clinical:
1. Adverse events
2. Clinical parameters (body weight, height, fat free mass)
3. Number of pulmonary exacerbations
4. Antimicrobial agent use
5. Quality of life questionnaire scores

Radiological:
1. Chest radiograph scored by CF chest radiograph scoring systems

Overall trial start date

01/01/2002

Overall trial end date

01/12/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

60

Participant 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

Recruitment start date

01/01/2002

Recruitment end date

01/12/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Universitair Medisch Centrum, locatie AZU
Utrecht
3508 GA
Netherlands

Sponsor information

Organisation

University Medical Centre Utrecht (UMCU) (The Netherlands)

Sponsor details

P.O. Box 85500
Utrecht
3508 GA
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

The Netherlands Organization for Scientific Research (NWO) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes