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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:
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EUCTR |
Last refreshed on:
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29 April 2013 |
Main ID: |
EUCTR2008-007877-19-DE |
Date of registration:
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28/05/2009 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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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:
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15/06/2009 |
Target sample size:
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14 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-007877-19 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Countries of recruitment
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Germany
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways MedDRA version: 9.1
Level: LLT
Classification code 10011762
Term: Cystic fibrosis
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Intervention(s)
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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-
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Primary Outcome(s)
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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
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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
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Main Objective: Decrease of Pseudomonas aeruginosa bacterial count in the nasal lavage fluid and in endoscopic swab at the ostium of the maxillary sinus
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Secondary ID(s)
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colistin nasal CF pilot
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Source(s) of Monetary Support
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Results
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Results available:
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