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Note: This record shows only 22 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.
Register: EUCTR
Last refreshed on: 29 April 2013
Main ID:  EUCTR2008-007877-19-DE
Date of registration: 28/05/2009
Prospective Registration: Yes
Primary sponsor: University of Jena
Public title: Nasale Inhalation von Colistin mit dem Pari-Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich. Nasal inhalation of colistin by the Pari Sinus nebulizer im patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - colistin nasal CF pilot
Scientific title: Nasale Inhalation von Colistin mit dem Pari-Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich. Nasal inhalation of colistin by the Pari Sinus nebulizer im patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - colistin nasal CF pilot
Date of first enrolment: 15/06/2009
Target sample size: 14
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-007877-19
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Phase: 
Countries of recruitment
Germany
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
1. Subject has a confirmed diagnosis of cystic fibrosis based on:
3 positive sweat chloride tests and/or genetic characterisation
2. detection of P. aeruginosa in nasal lavage (culture) with chronic P.
aeruginosa colonization of the lung (from day – 28)
3. informed consent of the patients or parents
4. Subject >= 6 years
5. Subject is able to comply with the inhalation procedures and nasal
lavage procedures scheduled in the protocol.
6. Women of childbearing potential are only included into the study, if they
are using an effective method of birth control during the protocol (e.g.
implants, combined oral contraceptives, injectables, some IUDs, sexual
abstinence or vasectomised partner)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. subject has a critical condition defined as:
FEV1 < 30% and / or
SaO2 < 93% without O2-substitution; need of O2-substitution
2. Subject had an ENT surgery within 3 months prior to study
3. Subject shows signs of nasal bleeding
4. Subject has an ear drum perforation
5. Subject had an acute rhinosinusitis or a pulmonary exacerbation at study
entry with need of additional systemic antibiotic therapy against
pseudomonas aerug.
6. Subject is unlikely to comply with the procedures scheduled in the protocol
7. Subject has contraindications and known side effects to the medication
8. Subject is pregnant or breastfeeding
9. Subject participates in another clinical trial within 30 days prior to study
entry or 30 days after end of the study.
10. Systemic (oral or intravenous) antibiotic treatment against P.a. 14 days
prior to the inclusion and during the study


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways
MedDRA version: 9.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis
Intervention(s)

Trade Name: Colistin CF
Product Name: Colistin CF
Pharmaceutical Form: Nebuliser solution
INN or Proposed INN: Colistimethat-Natrium
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 1 million-

Primary Outcome(s)
Secondary Objective: 1. drug safety of colistin nasal
2. changes of the Sino-nasal-outcome-test SNOT-20 adapt CF / patient`s diary
3. detection of P. aeruginosa in sputum / througt swab
4. genotyping of P. aeruginosa
5. changes of rhinoscopic findings (size of polyps, mucosa, secretions)
6. changes of rhinomanometric findings
7. cytology, cytokines in nasal lavage
8. incidence of rhinosinusitic and pulmonal exacerbations
Primary end point(s): Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid and in endoscopic swab at the ostium of the maxillary sinus
Main Objective: Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid and in endoscopic swab at the ostium of the maxillary sinus
Secondary Outcome(s)
Secondary ID(s)
colistin nasal CF pilot
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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